First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
Phase: PHASE1
Conditions: Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D, NRAS G12R, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Cholangiocarcinoma, Bile Duct Cancer, Gallbladder Carcinoma
Sponsor: Elicio Therapeutics

 
 
 
Protocol Amendment 
 
Study ID:  
ELI-002-001 
 
Title of Study: 
First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for 
Subjects with Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal 
Adenocarcinoma and Other Solid Tumors 
 
NCT ID:  
NCT04853017 
 
Date of Document: 07 August 2023 

TITLE PAGE 
Protocol Number: ELI-002-001 
Protocol Name: AMPLIFY-201 
First in Human Phase 1 Trial of ELI-002 Immunotherapy 
as Treatment for Subjects with Kirsten Rat Sarcoma 
(KRAS) Mutated Pancreatic Ductal Adenocarcinoma and 
Other Solid Tumors 
 
SPONSOR 
Elicio Therapeutics, Inc. 
 
 
Sponsor Contact: Esther Welkowsky, SVP of Clinical Development  
Phone: (805) 886-5846 
Email: ESTHER.WELKOWSKY@ELICIO.COM 
 
Lead Medical Monitor: Christopher M. Haqq, MD, PhD, Chief Medical Officer 
Phone: (805) 630-2596 
Email: CHRIS.HAQQ@ELICIO.COM 
 
Protocol Version: Version 8.0 Dated 07 August 2023 
Supersedes: Version 7.0 Dated 25 January 2023 
 
 
 

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SIGNATURE PAGE 
 
 
 
 
 
Christopher Haqq, M.D. Ph.D. 
Chief Medical Officer 
Elicio Therapeutics, Inc. 
 
 
 
 
Date 
Esther Welkowsky 
SVP, Clinical Development  
Elicio Therapeutics, Inc. 
 
 
 
 
Date 
Joycelyn Seymour 
VP, Regulatory Affairs 
Elicio Therapeutics, Inc. 
 
Date 
 

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INVESTIGATOR’S AGREEMENT 
I have read and reviewed the ELI-002-001 Protocol, version 8.0, dated 07 August 20232023, and 
agree to conduct the trial as outlined and with all applicable regulations including the current 
International Conference on Harmonization guidelines.  
I agree to provide copies of the ELI-002-001 Protocol and the Investigator’s Brochure for 
ELI-002, provided by the Sponsor (Elicio Therapeutics), to all members of the study team. I will 
ensure that all members of the study team are fully trained regarding the study drug and conduct 
of the study. 
I agree to make available to Elicio Therapeutics, their representatives, and regulatory authorities, 
the study records of each subject in order to verify the data that Elicio Therapeutics has entered 
into the case report forms. I am aware of my responsibilities as a study investigator as provided 
by the Sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator 
 
 
 
 
 
 
 
 
Date 

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PROCEDURES IN CASE OF EMERGENCY 
Emergency contact information is provided in Table 1. 
Table 1: 
Emergency Contact Information 
Role in Trial 
Name 
Email and Telephone Number 
Clinical Operations 
Esther Welkowsky 
Esther.Welkowsky@elicio.com  
(805) 886-5846 
Responsible Physician 
Christopher Haqq, MD, PhD 
Chris.Haqq@elicio.com  
(805) 630-2596 
24-Hour Emergency 
Contact 
Christopher Haqq, MD, PhD 
Chris.Haqq@elicio.com  
(805) 630-2596 
 

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1. 
SYNOPSIS 
Name of Sponsor/Company: Elicio Therapeutics, Inc. (hereafter, referred to as Elicio) 
Name of Investigational Product: ELI-002 
Name of Active Ingredient: ELI-002 is an 8-component product consisting of: up to 7 lipid-
conjugated peptide-based antigens (amphiphilic peptides, referred to as ‘Amph-Peptides’) and a lipid-
conjugated immune-stimulatory oligonucleotide (‘Amph-CpG-7909’) dosed after an admixing 
procedure of the respective Amph-Peptide and Amph-CpG-7909 drug products. 
During the Phase 1 (dose escalation) study, the Amph-Peptide mixture (Amph-Peptides 2P) will be 
comprised of 1.4 mg of 2 Amph modified KRAS peptides, Amph-G12D, and Amph-G12R 
(0.7 mg/peptide). Elicio plans to investigate the use of an Amph-Peptide 7P drug product containing 
all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) in future clinical trials. 
Protocol Number: ELI-002-001 
Phase: 1  
Country: United States (of America)  
Title of Trial: First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects 
with Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other 
Solid Tumors 
Trial centers: Multicenter  
Investigators: Multicenter 
Studied period (years):  
Date first subject enrolled: 4Q2021 
Date last subject enrolled: 2Q2023 
Hypothesis:  
ELI-002 is safe and the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) 
can be established at the end of the Phase 1 dose escalation. 
Phase 1 Primary Objective: 
• 
To assess the safety and tolerability of ELI-002 as adjuvant therapy for subjects with 
KRAS mutated PDAC and other solid tumors who have minimal residual disease (MRD) 
identified using either circulating tumor DNA (ctDNA) or a serum tumor biomarker  
• 
To define the MTD (in the event there is an MTD) and RP2D 
Phase 1 Secondary Objective: 
• 
To assess ctDNA reduction and clearance, defined as reduction or clearance in ctDNA 
compared to baseline, or if ctDNA was not detectable at baseline, serum tumor biomarker 
(such as carbohydrate antigen [CA]19-9, carcinoembryonic antigen [CEA], and CA-125) 
reduction and clearance compared to baseline  
Phase 1 Exploratory Objectives: 
• 
To report the median relapse-free survival (RFS) and median overall survival (OS) 
• 
To assess the change relative to baseline in: 

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− 
Serum cytokines interleukin (IL)-2, interferon gamma (IFNγ), IL-6, IL-10, and tumor 
necrosis factor alpha (TNFα) 
− 
Patient reported outcomes (PROs): European Organization for Research and 
Treatment of Cancer (EORTC) Quality of Life Questionnaire [QLQ]-C30 and 
QLQ-PAN26, QLQ-CR29, QLQ-OV28, QLQ-BIL21, or QLQ-LC13 
− 
To evaluate the immunogenicity of ELI-002. T cell responses to ELI-002 will be 
assessed using assays such as intracellular cytokine staining (ICS), Fluorospot, and/or 
dextramer+ T cells for subjects with human leukocyte antigen (HLA) alleles for 
which dextramer/s is/are available 
− 
Biomarker levels (ctDNA, CA19-9, CEA, and CA-125) 
− 
To evaluate tumor-infiltrating T cells and the tumor microenvironment after dosing 
with ELI-002 
• 
To correlate biomarker data to clinical safety and efficacy (RFS, OS)  
Primary Endpoints: 
• 
To define the MTD of ELI-002 (in the event there is an MTD) and the RP2D  
• 
To evaluate safety as assessed by the incidence of adverse events (AEs) and clinically 
significant changes in laboratory tests and vital signs 
Secondary Endpoint: 
• 
To report the proportion of subjects with ctDNA reduction and clearance, defined as 
reduction or clearance in ctDNA compared to baseline, or if ctDNA was not detectable at 
baseline, serum tumor biomarker (such as CA19-9, CEA, and CA-125) reduction and 
clearance compared to baseline  
Exploratory Endpoints: 
• 
Median RFS and median OS 
• 
Duration of biomarker (ctDNA or serum tumor biomarker) clearance and reduction, 
defined as time from the date of the first negative and/or decreased biomarker to the 
earliest date of any of the following events: 
− 
Subsequent increased/positive biomarker  
− 
Subsequent disease relapse 
− 
Death due to any cause  
• 
Change relative to baseline in: 
− 
Serum cytokines IL-2, IFNγ, IL-6, IL-10, and TNFα 
− 
PROs: EORTC QLQ-C30 and QLQ-PAN26, QLQ-CR29, QLQ-OV28, QLQ-BIL21 
or QLQ-LC13 
− 
Immunogenicity of ELI-002 determined by magnitude of response and fold-change 
from baseline, using assays such as ICS, Fluorospot, and/or dextramer+ T cells for 
subjects with HLA alleles for which dextramer/s is/are available 
− 
Biomarker levels (ctDNA, CA19-9, CEA, and CA-125) 
− 
Immune cell infiltrate and tumor microenvironment if standard of care biopsies are 
obtained to confirm disease progression 
 
 

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Trial Design: 
ELI-002-001 is an open-label, Phase 1 trial of ELI-002 immunotherapy as adjuvant treatment for 
subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC and other 
solid tumors who are at high risk for relapse (ie, presence of isolated tumor cells as detected by 
ctDNA or elevated serum tumor biomarkers in the subject’s body, in which the primary tumor has 
been removed and is currently without clinical signs of disease). For this protocol, high relapse risk is 
defined by either a ctDNA-positive result, or elevated serum tumor biomarker (such as CA19-9, CEA, 
or CA-125). 
This Phase 1 (dose escalation) trial comprises an open-label, single arm, dose-escalation trial 
incorporating a 3+3 design in subjects with mutant KRAS (mKRAS)/mutant NRAS (mNRAS) solid 
tumors (PDAC, CRC, non-small cell lung cancer [NSCLC], ovarian, cholangiocarcinoma [CCA] and 
gallbladder carcinoma). 
Approximately 18 subjects are planned to be enrolled in the dose escalation to evaluate the safety, 
tolerability, and exploratory pharmacodynamic efficacy of subcutaneous (SC) ELI-002 using the 
adjuvant at 3 planned dose levels (Amph-CpG-7909 0.1 mg SC, 0.5 mg SC, 2.5 mg SC) in 
combination with a fixed dose of Amph-Peptides (700 μg each). Additional cohorts may be added to 
explore intermediate or higher dose levels based on the cumulative safety review and preliminary 
review of pharmacodynamic responses. If additional cohorts are added, this will be documented in a 
study memo sent to all clinical sites and submitted to IRBs, per IRB guidance. 
During the dose escalation study, ELI-002 will be comprised of 1.4 mg of two Amph modified KRAS 
peptides G12D and G12R admixed with Amph-CpG-7909 to provide ELI-002 2P. Elicio plans to 
investigate the use of an Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, 
G12R, G12V, G12A, G12C, G12S, G13D) admixed with Amph-CpG-7909 (ELI-002 7P) in future 
clinical trials. 
Subjects in Phase 1 will receive the initial dose of ELI-002 2P and be monitored for 24 hours in 
order to assess for potential AEs such as cytokine release syndrome (CRS). In addition, there will also 
be a 1-week stagger between enrollment of the first subject in a cohort and the subsequent subjects. In 
the absence of toxicity during the dose-limiting toxicity (DLT) assessment window, the ELI-002 2P 
dose will be escalated. Planned cohort dose levels are listed below: 
• 
Cohort 1: Dose Level 1: Amph-CpG-7909 0.1 mg with Amph-Peptides 
• 
Cohort 2: Dose Level 2: Amph-CpG-7909 0.5 mg with Amph-Peptides 
• 
Cohort 3: Dose Level 3: Amph-CpG-7909 2.5 mg with Amph-Peptides 
Cohorts will consist of 3 to 6 subjects (the number will depend on whether DLTs are observed). In 
order to ensure an adequate number of evaluable subjects, up to 6 subjects may be enrolled per cohort 
even in the absence of a DLT. Once the RP2D is determined, the cohort evaluating the Phase 2 dose 
will be expanded as needed so that there is safety experience with at least 6 subjects at this dose level.  
Dose escalation from one cohort to the next will be determined by the Safety Monitoring Committee 
(SMC), and will be based on treatment-emergent AEs, clinical laboratory data, physical examination 
(PE) findings including vital signs, after all subjects within a cohort have completed 28 days. At each 
SMC meeting, longer follow-up will be available on all but the final subject in each cohort. The SMC 
will review all available long-term safety information from prior cohorts (if any), so that the SMC 
will consider the totality of the safety information in their recommendation. 
In any cohort, if none of the subjects experience a DLT during the first 28 days following first 
administration of ELI-002, dose escalation will occur, and 3 subjects will be enrolled in the cohort at 
the next dose level. However, if 1 of the 3 or 4 initial subjects in a cohort experiences a DLT, then 
3 (or 2, if 4 were originally enrolled) additional subjects will be enrolled at the same dose level. If 
2 or more of 3 subjects within a cohort experience a DLT, then this dose will be considered the toxic 

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dose. If only 1 of 6 subjects within a cohort experiences a DLT during the first 28 days of treatment, 
then the next cohort may begin enrollment. If 2 or more of 6 subjects within a cohort experience a 
DLT during the first 28 days, then this dose will be considered the toxic dose. The trial may proceed 
at a lower dose, at a less frequent schedule, or omitting the Amph-CpG-7909 adjuvant while 
continuing to administer the Amph-Peptides, based on emerging toxicity or pharmacodynamic data 
until the MTD is determined. 
A trial memo will be sent to all sites following each SMC cohort review meeting summarizing the 
decision; if additional cohorts are to be enrolled, the dose level and schedule will be provided. 
The RP2D will be defined in consideration of the MTD (if any), safety data, and pharmacodynamic 
data. The RP2D will be communicated to all sites in a trial memo following the last SMC cohort 
review.  
Subject replacement: If a subject discontinues for any reason other than toxicity prior to completing 
28 days of ELI-002 therapy, a replacement subject will be added to the cohort until 3 subjects per 
cohort complete 28 days of ELI-002 therapy.  
DLT definition: A DLT will be defined as any event at least possibly related to ELI-002 as follows: 
a. Any Grade ≥ 3 non-hematologic toxicity except asymptomatic laboratory abnormalities 
(see Section 12.2.1.1) 
b. Any Grade ≥ 3 toxicity involving major organ systems for greater than 72 hours and 
occurring within 28 days of subcutaneous administration 
c. Grade 3 CRS that does not resolve to ≤ Grade 2 within 7 days 
d. Any Grade 4 CRS that does not improve to < Grade 2 within 72 hours 
e. Any Grade ≥ 3 autoimmune disorder 
f. Any Grade ≥ 3 rash that does not resolve to ≤ Grade 1 within 7 days with appropriate 
treatment 
The DLT observation period will be 28 days. 
MTD definition: The MTD is defined as the highest dose level with a DLT incidence <33% of cohort 
subjects. 
The trial will consist of a Screening Period, an Immunization Period, a No Dosing 3-Month Period, a 
Booster Period, and a Follow-up Period.  
A Booster Period is provided as further lymph node antigen exposure may be required to maintain 
effective levels of antigen-specific T-cells. All subjects will receive booster doses unless they have 
unresolved toxicity. 
All subjects will be observed for safety and tolerability. CT imaging with contrast will occur at 
screening and 35 days post first dose and at additional timepoints until radiographic relapse is 
observed. 
The central laboratory will confirm ≥1 of 2 mutant KRAS/NRAS alleles targeted by ELI-002 Amph-
Peptides 2P (G12D, and G12R,) is present and central laboratory ctDNA must be positive or there 
must be serum tumor biomarker (such as CA19-9, CEA, and CA-125) elevation at ≥21 days 
post-surgery or after last administration of adjuvant therapy (whichever comes last in the specific 
subject treatment plan). These data are required for determination of eligibility and inclusion into the 
trial.  
Immunologic biomarkers of response may include HLA typing, serum cytokines, ICS, Fluorospot, 
dextramer+ T cells for subjects with appropriate HLA alleles will be determined when matching 
dextramer/s is/are available. 
Local laboratories will be utilized for serum cytokine testing, tumor biomarkers 
CA19-9/CEA/CA-125 (as appropriate per tumor type), tumor biopsy assays (such as biomarker 
sequencing and/or IHC assays) and all other safety laboratory tests.  

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Central laboratories will be utilized for ctDNA analysis, HLA typing, peripheral blood mononuclear 
cell (PBMC) isolation and immunogenicity assessment (such as Fluorospot, ICS, and/or T cell 
dextramer testing) as detailed in the central laboratory manual. 
While HLA testing will be performed prior to first dose at Visit 3, cohorts will be enrolled regardless 
of the HLA subtype.  
Discontinuation of Trial Treatment: Subjects with confirmed radiographic relapse (using iRECIST 
criteria; not judged as pseudoprogression) during treatment with ELI-002 will discontinue trial 
treatment but should continue other trial-related procedures in the follow-up period.  
The design of the Phase 1 trial is outlined in the following figure. 
ELI-002 Study Cohort Schematic 
 
All cohorts are open to enrollment of subjects with RAS mutated PDAC, CRC, NSCLC, and other 
solid tumors (OST; including ovarian, bile duct and gallbladder carcinoma).  
 

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Sample Size Justification: The sample size for the Phase 1 dose escalation is not based on power 
calculations, but rather on clinical judgement and the expectation that the objectives of this part of the 
trial will be met with approximately 18 subjects enrolled in the 3+3 design. 
Number of Subjects (planned): In the Phase 1 Dose Escalation approximately 18 subjects are 
planned to enroll: 3 to 6 subjects in Cohort 1; 3 to 6 subjects in Cohort 2; and 3 to 6 subjects in 
Cohort 3.  
Diagnosis and Main Criteria for Inclusion: Males or females ≥18 years of age with histologically 
or cytologically confirmed diagnosis of solid tumor with central laboratory analysis confirming the 
presence of at least 1 of the 2 KRAS/NRAS mutations targeted by ELI-002 Amph-Peptides 2P. 
Investigational Product, Dosage and Mode of Administration:  
ELI-002 is an investigational product consisting of 2 lipid-conjugated peptide (G12R and G12D) 
based antigens (amphiphilic peptides, referred to as ‘Amph-Peptides’) and a lipid-conjugated 
immune-stimulatory oligonucleotide (‘Amph-CpG-7909’) dosed after an admixing procedure of the 
respective Amph-Peptides 2P and Amph-CpG-7909 drug products (referred to as ELI-002 in this 
protocol). In the event of toxicity after immunization doses, Amph-Peptides without Amph-CpG-
7909 adjuvant may be administered during the booster period. Elicio plans to investigate the use of an 
Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, 
G12S, G13D) admixed with Amph-CpG-7909 (ELI-002 7P) in future clinical trials. 
The doses planned to be evaluated in Phase 1 are as shown below:  
Phase  
Cohort 
Tumor 
Dose Level 
Phase 1 
Dose 
Escalation 
Cohort 1 
KRAS/NRAS mutated 
solid tumors 
Amph-CpG-7909 0.1 mg with Amph-Peptides 
Cohort 2 
KRAS/NRAS mutated 
solid tumors 
Amph-CpG-7909 0.5 mg with Amph-Peptides 
Cohort 3 
KRAS/NRAS mutated 
solid tumors 
Amph-CpG-7909 2.5 mg with Amph-Peptides 
CRC=colorectal cancer; KRAS=Kirsten Rat Sarcoma; NRAS=neuroblastoma ras viral oncogene homolog; 
NSCLC=non-small cell lung cancer; OST=other solid tumors; PDAC=pancreatic ductal adenocarcinoma 
Duration of Treatment: The total duration of participation for each subject is approximately 2 years, 
and includes a Screening Period, an Immunization Period, a No Dosing 3-Month Period, a Booster 
Period, and a Follow-up Period.  
Subjects who remain in the trial until the end of the required Follow-up Period may be eligible to 
enroll in an Extension Protocol. 
Reference Therapy, Dosage and Mode of Administration: None 
Criteria for Evaluation: 
Safety: Adverse events will be recorded and categorized using CTCAE, Version 5. If observed, 
CRS/ICANS will be recorded and managed according to the American Society for Transplantation 
and Cellular Therapy (ASTCT) consensus criteria. 
Standard clinical chemistry and hematology assays, PEs, vital sign measurements, 
electrocardiograms, and ECOG performance status will be assessed/performed at specified times 
during the trial.  
A SMC comprised of the site investigators, sponsor medical monitor, drug safety and clinical 
operations, will meet for each dose escalation. The SMC will have the authority to assess and 

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recommend any dosing changes warranted due to safety concerns or as otherwise warranted to protect 
the safety of the subjects in the trial.  
Efficacy: Median RFS and 1-year RFS rate will be assessed through imaging using iRECIST criteria; 
subjects will be followed for OS. In addition, biomarker (ctDNA or serum tumor biomarker) response 
rate will be based on the percentage of subjects achieving biomarker reduction or clearance, as 
measured by the reduction or absence of the biomarker, and the duration of biomarker reduction 
and/or clearance will be recorded.  
Immunogenicity: Patients will have leukapheresis and blood samples drawn to evaluate the 
immunogenicity of ELI-002. T cell responses in PBMCs will be assessed by immune assays such as 
IFN Fluorospot, ICS, and/or dextramers. Serum cytokine, CEA, CA-125 and CA 19-9 levels will 
also be examined. Immune responses will be correlated to clinical efficacy parameters. 
Standard of care tumor biopsies: may be collected post-dose per iRECIST, and if there is sufficient 
tumor tissue collected, will be assayed at the local laboratory to examine tumor-infiltrating T cells and 
the tumor microenvironment. Potential assays could include in situ gene expression and/or IHC. 
Statistical Methods: Descriptive statistics will be generated to summarize demographic, medical 
history, and safety data.  
As a general approach, continuous variables will be summarized using mean, standard deviation, 
median, minimum value, maximum value. Categorical variables will be summarized using frequency 
counts and percentages. Time to event data will be summarized using the Kaplan-Meier method. 
Where appropriate, confidence intervals around point estimates will be presented, and estimates of the 
median and other quantiles, as well as individual time points (for time to event data) will be produced.  
All statistical hypothesis testing within (for change from baseline) and between dose cohorts will be 
conducted at the 1-sided 0.05 level of significance. Nominal p-values may be computed for secondary 
or exploratory efficacy analyses as a descriptive measure of strength of results rather than for formal 
tests of hypotheses. Emphasis will be on RP2D, highest dose, and combined RP2D and all higher 
doses for change from baseline and comparison to lowest dose. No formal tests of hypotheses are 
planned for safety analyses.  
Immunogenicity analyses: A positive immune response for each KRAS/NRAS peptide will be 
determined, for example, using a non-parametric distribution-free resampling method with the 
Fluorospot assay. T cell responses to ELI-002 will be summarized for each patient by magnitude of 
response and fold-change from baseline for each timepoint tested. Immune responses will be 
summarized for each Cohort. 
 

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2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES  
TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR’S AGREEMENT ...............................................................................................3 
PROCEDURES IN CASE OF EMERGENCY ...............................................................................4 
1. 
SYNOPSIS ...................................................................................................................5 
2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............12 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.............................19 
4. 
INTRODUCTION ......................................................................................................23 
4.1. 
Summary of Pancreatic Cancer and Other Solid Tumors ...........................................25 
4.1.1. 
Pancreatic Cancer .......................................................................................................25 
4.1.2. 
Colorectal Cancer .......................................................................................................29 
4.1.2.1. 
Introduction .................................................................................................................29 
4.1.2.2. 
Adjuvant Therapy in the Case of Localized CRC Disease .........................................29 
4.1.2.3. 
Rectal Cancer ..............................................................................................................30 
4.1.2.4. 
Colorectal Liver Metastases .......................................................................................30 
4.1.2.5. 
Frequency of KRAS and NRAS Mutations in CRC ...................................................31 
4.1.2.6. 
Importance of ctDNA and CEA Assessment and Follow-up in CRC ........................32 
4.1.2.7. 
Colorectal Cancer and Vaccines .................................................................................33 
4.1.3. 
Non-small Cell Lung Cancer ......................................................................................34 
4.1.3.1. 
KRAS Mutations in NSCLC ......................................................................................34 
4.1.3.2. 
Circulating Tumor DNA in NSCLC ...........................................................................35 
4.1.4. 
Ovarian Carcinoma .....................................................................................................35 
4.1.4.1. 
Ovarian KRAS Mutations...........................................................................................36 
4.1.4.2. 
Circulating Tumor DNA in Ovarian Cancer ..............................................................37 
4.1.5. 
Cholangiocarcinoma ...................................................................................................37 
4.1.5.1. 
Cholangiocarcinoma KRAS Mutations ......................................................................38 
4.1.6. 
Gallbladder Cancer .....................................................................................................39 
4.2. 
Brief Summary of Nonclinical Pharmacology ...........................................................39 
4.3. 
Brief Summary of Pharmacokinetics and Toxicokinetics ..........................................46 
4.4. 
Brief Summary of Toxicology ....................................................................................46 

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4.4.1. 
Repeat-Dose Toxicity Studies ....................................................................................46 
4.4.1.1. 
Study No. 2795-001: Amph-CpG-7909 (with and without Amph-Peptide-
G12D): A 4-Week Subcutaneous Injection Tolerability Study in Male 
C57BL/6 Mice ............................................................................................................46 
4.4.1.2. 
Study 2795-002: A GLP 3-Month Study of ELI-002 by Subcutaneous 
Injection in C57BL/6 Mice with a 5-Week Recovery Period .....................................47 
4.5. 
Safety Pharmacology ..................................................................................................47 
4.6. 
ELI-002: An Investigational Treatment for KRAS/NRAS Mutated Solid 
Tumors ........................................................................................................................48 
4.6.1. 
Mechanism of Action .................................................................................................48 
4.6.2. 
Amphiphile Lymph Node Delivery Background .......................................................48 
4.6.3. 
Known and Potential Risks and Benefits....................................................................49 
4.6.4. 
Trial Rationale ............................................................................................................51 
4.6.5. 
Rationale for Endpoints ..............................................................................................53 
4.6.6. 
Rationale for Dose Selection ......................................................................................54 
5. 
TRIAL OBJECTIVES ................................................................................................55 
5.1. 
Primary Objectives .....................................................................................................55 
5.2. 
Secondary Objective ...................................................................................................55 
5.3. 
Exploratory Objectives ...............................................................................................55 
6. 
INVESTIGATIONAL PLAN .....................................................................................56 
6.1. 
Overall Trial Design ...................................................................................................56 
6.1.1. 
Safety Monitoring .......................................................................................................59 
6.1.2. 
Criteria for Booster and Additional Booster Vaccines ...............................................60 
6.1.3. 
Screening for Human Leukocyte Antigen Subtypes ..................................................60 
6.1.4. 
Schedule of Assessments ............................................................................................60 
6.1.5. 
Risk Determination for Investigational In Vitro Diagnostics .....................................72 
6.1.5.1. 
Description of the IVDs ..............................................................................................73 
6.1.5.2. 
Applying the IVD Results in the Clinical Trial ..........................................................75 
6.2. 
Endpoints ....................................................................................................................75 
6.2.1. 
Primary Endpoints ......................................................................................................75 
6.2.2. 
Secondary Endpoint ....................................................................................................75 
6.2.3. 
Exploratory Endpoints ................................................................................................75 
6.3. 
Number of Subjects ....................................................................................................76 

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6.4. 
Treatment Assignment ................................................................................................76 
6.5. 
Dose Adjustment Criteria ...........................................................................................76 
6.6. 
Safety Criteria for Temporarily or Permanently Stopping the Trial ...........................76 
6.7. 
Management of Study Drug-Related Events ..............................................................77 
6.7.1. 
Temporarily Suspending Treatment Administration ..................................................77 
6.7.2. 
Permanent Stopping Treatment Administration .........................................................77 
6.7.3. 
Dose-limiting Toxicity Guidelines .............................................................................78 
6.8. 
Management of Risks and Toxicities .........................................................................78 
6.8.1. 
Management of Cytokine Release Syndrome .............................................................79 
6.8.2. 
Cytokine Release Syndrome Treatment Guidelines ...................................................81 
6.8.3. 
ICANS Treatment Guidelines .....................................................................................83 
6.8.4. 
Management of On-target Off-tumor Toxicity ...........................................................85 
6.8.5. 
Management of Maculo-Papular or Acneiform Rashes, Injection Site 
Reactions .....................................................................................................................85 
7. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................86 
7.1. 
Subject Inclusion Criteria ...........................................................................................86 
7.2. 
Subject Exclusion Criteria ..........................................................................................89 
7.3. 
Subject Withdrawal Criteria .......................................................................................90 
7.3.1. 
Subject Replacement ..................................................................................................91 
7.3.2. 
Subjects Lost to Follow-up .........................................................................................91 
8. 
TREATMENT OF SUBJECTS ..................................................................................92 
8.1. 
Concomitant Medications ...........................................................................................92 
8.1.1. 
Prohibited Concomitant Medications .........................................................................92 
8.2. 
Treatment Compliance ................................................................................................92 
8.3. 
Randomization and Blinding ......................................................................................92 
9. 
TRIAL DRUG MATERIALS AND MANAGEMENT .............................................93 
9.1. 
Trial Drug ...................................................................................................................93 
9.2. 
Trial Drug Packaging and Labeling ............................................................................93 
9.3. 
Trial Drug Storage ......................................................................................................93 
9.4. 
Trial Drug Preparation ................................................................................................93 
9.5. 
Administration and Dosage ........................................................................................94 
9.6. 
Trial Drug Accountability ...........................................................................................94 
9.7. 
Trial Drug Handling and Disposal ..............................................................................94 

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10. 
TIMING OF TRIAL PROCEDURES ........................................................................95 
10.1. 
Screening and Observation Period ..............................................................................95 
10.1.1. 
Rescreening .................................................................................................................96 
10.2. 
Immunization Period ..................................................................................................97 
10.3. 
No Dosing 3-Month Period ......................................................................................101 
10.4. 
Booster Period ..........................................................................................................102 
10.5. 
Follow-up Period ......................................................................................................106 
11. 
CLINICAL ACTIVITY, IMMUNE ASSESSMENTS, AND SUBJECT 
REPORTED OUTCOMES .......................................................................................108 
11.1. 
Immunogenicity ........................................................................................................108 
11.2. 
Tumor Tissue Collection at Surgery .........................................................................109 
11.3. 
Patient Reported Outcomes ......................................................................................109 
11.3.1. 
EORTC QLQ-C30 ....................................................................................................109 
11.3.2. 
Tumor type-specific PROs .......................................................................................109 
11.4. 
ctDNA Levels ...........................................................................................................110 
12. 
ASSESSMENT OF SAFETY ...................................................................................111 
12.1. 
Safety Parameters .....................................................................................................111 
12.1.1. 
Demographics and Medical History .........................................................................111 
12.1.2. 
Vital Signs ................................................................................................................111 
12.1.3. 
Physical Examinations ..............................................................................................111 
12.1.4. 
Electrocardiogram .....................................................................................................111 
12.1.5. 
Eastern Cooperative Oncology Group ......................................................................111 
12.1.6. 
Laboratory Assessments ...........................................................................................111 
12.1.6.1. 
Hematology ...............................................................................................................112 
12.1.6.2. 
Coagulation ...............................................................................................................112 
12.1.6.3. 
Blood Chemistry .......................................................................................................112 
12.1.6.4. 
Serum Cytokines .......................................................................................................113 
12.1.6.5. 
Viral Laboratory Testing at Screening .....................................................................113 
12.1.6.6. 
Pregnancy Screen ......................................................................................................113 
12.2. 
Adverse and Serious Adverse Events .......................................................................113 
12.2.1. 
Definition of Adverse Events ...................................................................................113 
12.2.1.1. 
Adverse Event ...........................................................................................................113 
12.2.1.2. 
Serious Adverse Event ..............................................................................................114 

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12.2.1.3. 
Reactogenicity to the Vaccine ..................................................................................114 
12.2.1.4. 
Cytokine Release Syndrome .....................................................................................115 
12.3. 
Relationship to Trial Drug ........................................................................................115 
12.4. 
Severity of Adverse Events ......................................................................................116 
12.5. 
Recording Adverse Events .......................................................................................116 
12.6. 
Pregnancy .................................................................................................................117 
12.7. 
Reporting Adverse Events ........................................................................................117 
12.8. 
Extension Protocol ....................................................................................................118 
13. 
STATISTICS ............................................................................................................119 
13.1. 
Sample Size ..............................................................................................................119 
13.2. 
General Statistical Considerations and Definitions ..................................................119 
13.2.1. 
General Statistical Methods ......................................................................................119 
13.2.2. 
Analysis Population ..................................................................................................120 
13.2.2.1. 
Full Analysis Set (FAS) ............................................................................................120 
13.2.2.2. 
Safety Analysis Set ...................................................................................................120 
13.2.2.3. 
Disease Response Evaluable Set ..............................................................................120 
13.2.2.4. 
Per Protocol Set ........................................................................................................121 
13.2.2.5. 
PD/Biomarker Evaluable Set ....................................................................................121 
13.2.3. 
Missing Data .............................................................................................................121 
13.3. 
Statistical Analyses ...................................................................................................121 
13.3.1. 
Demographic and Background Characteristics ........................................................121 
13.3.2. 
Immunogenicity Analysis .........................................................................................121 
13.3.3. 
Efficacy Analysis ......................................................................................................121 
13.3.3.1. 
Relapse-free survival ................................................................................................121 
13.3.3.2. 
Analysis of Biomarker Response..............................................................................122 
13.3.3.3. 
Analysis of Duration of Biomarker Response ..........................................................122 
13.3.3.4. 
Analysis of 1-Year RFS ............................................................................................122 
13.3.3.5. 
Analysis of OS ..........................................................................................................122 
13.3.4. 
Safety Analysis .........................................................................................................123 
13.3.5. 
Pharmacokinetics ......................................................................................................123 
13.3.6. 
Pharmacodynamics ...................................................................................................123 
14. 
DATA INTEGRITY AND QUALITY ASSURANCE ............................................124 

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14.1. 
Data Management and Case Report Forms ..............................................................124 
14.2. 
Source Documentation ..............................................................................................124 
14.3. 
Study Drug Accountability .......................................................................................124 
14.4. 
Laboratory Assessments ...........................................................................................125 
14.5. 
Trial Monitoring .......................................................................................................125 
14.6. 
Protocol Deviations ..................................................................................................125 
14.7. 
Audits and Inspections ..............................................................................................125 
14.8. 
Institutional Review Board and Other Committees ..................................................126 
14.8.1. 
Institutional Review Board .......................................................................................126 
14.8.2. 
Safety Monitoring Committees.................................................................................126 
15. 
ETHICS ....................................................................................................................127 
15.1. 
Ethical Conduct of the Trial .....................................................................................127 
15.2. 
Written Informed Consent ........................................................................................127 
16. 
DATA HANDLING AND RECORDKEEPING .....................................................128 
16.1. 
Retention of Records ................................................................................................128 
17. 
PUBLICATION POLICY ........................................................................................129 
18. 
LIST OF REFERENCES ..........................................................................................130 
19. 
APPENDICES ..........................................................................................................141 
19.1. 
ECOG Performance Status Scale ..............................................................................141 
 
LIST OF TABLES 
Table 1: 
Emergency Contact Information ...................................................................................4 
Table 2: 
Abbreviations and Specialist Terms ...........................................................................19 
Table 3: 
Peptide Elements of Amph-Peptides ..........................................................................24 
Table 4: 
KRAS Mutation Spectrum in Pancreatic Cancer ........................................................28 
Table 5: 
Colon and Rectal Cancer KRAS and NRAS Mutation Spectrum ..............................31 
Table 6: 
KRAS Mutation Spectrum in Non-small Cell Lung Cancer ......................................34 
Table 7: 
KRAS Mutation Spectrum in Ovarian Tumors ..........................................................36 
Table 8: 
KRAS Mutation Frequency in Ovarian Tumors .........................................................37 
Table 9: 
KRAS Mutation Spectrum in Cholangiocarcinoma ...................................................38 
Table 10: Nonclinical Pharmacology studies of mKRAS Vaccine in Support of ELI-
002 (Model = Female C57BL/6 Mice, 5, 10 or 15/group) .........................................41 

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Table 11: Schedule of Assessments- Screening and Observation ..............................................61 
Table 12: Schedule of Assessments- Immunization Period ........................................................63 
Table 13: Schedule of Assessments- No Dosing 3-Month Period ..............................................65 
Table 14: Schedule of Assessments- Booster Period ..................................................................67 
Table 15: Schedule of Assessments- Follow-up Period (Year 1 to Year 2) ...............................69 
Table 16: Schedule of Assessments- Follow-up Period (Year 2 to Year 3) ...............................71 
Table 17: Clinical Symptoms of Cytokine Release Syndrome ...................................................80 
Table 18: Suggested Treatment by Cytokine Release Syndrome Grade ....................................81 
Table 19: High-dose Vasopressors (All Doses are Required for ≥3 Hours) ...............................81 
Table 20: Encephalopathy Assessment Tool for Grading ICANS .............................................83 
Table 21: ASTCT ICANS Consensus Grading for Adults .........................................................84 
Table 22: Neurotoxicity Suggested Treatment ...........................................................................85 
Table 23: Phase 1 Cohorts and Doses .........................................................................................94 
Table 24: ECOG Performance Status Scale ..............................................................................141 
 
LIST OF FIGURES 
Figure 1: 
Structure of Amph-CpG-7909 ....................................................................................24 
Figure 2: 
ELI-002 Trial Cohort Schematic ................................................................................58 
Figure 3: 
Protocol ELI-002-001: Phase 1 Trial Design .............................................................58 
Figure 4: 
Flow Diagram of ELI-002-001 Eligibility Determination using the IVD 
assays ..........................................................................................................................73 
 

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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this trial protocol. 
Table 2: 
Abbreviations and Specialist Terms  
Abbreviation or 
Specialist Term 
Explanation 
ADL 
Activities of daily life 
AE 
Adverse event 
AIDS 
Acquired immune deficiency syndrome 
AJCC 
American Joint Committee on Cancer 
ALT 
Alanine aminotransferase 
APC 
Antigen-presenting cell 
AST 
Aspartate aminotransferase 
ASTCT 
American Society for Transplantation and Cellular Therapy 
BUN 
Blood urea nitrogen 
CA 
Carbohydrate antigen (cancer antigen) 
CAP 
College of American Pathologist 
CAR 
Chimeric antigen receptor  
CBC 
Complete blood count 
CCA 
Cholangiocarcinoma 
CEA 
Carcinoembryonic antigen 
CGP 
Comprehensive Genomic Profiling 
CI 
Confidence interval 
CLIA 
Clinical Laboratory Improvement Amendment 
CRC 
Colorectal cancer 
CRP 
C-reactive protein 
CRS 
Cytokine release syndrome 
CSF 
Cerebrospinal fluid 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events, Version 5 
ctDNA 
Circulating tumor deoxyribonucleic acid  
Da 
Daltons 
dCCA 
Distal cholangiocarcinoma 
DLT 
Dose-limiting toxicity 

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Abbreviation or 
Specialist Term 
Explanation 
DMC 
Data Monitoring Committee 
DFS 
Disease-free survival 
EDTA 
Ethylenediaminetetraacetic acid 
EEG 
Electroencephalogram 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic Case Report Form 
EORTC 
European Organization for Research and Treatment of Cancer 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
5-FU 
5-fluorouracil 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GM-CSF 
Granulocyte-macrophage colony-stimulating factor 
GMP 
Good Manufacturing Practices 
HbsAG 
Hepatitis B virus surface antigen 
HCV 
Hepatitis C virus 
HIV 
Human immunodeficiency virus 
HLA 
Human leukocyte antigen 
HR 
Hazard ratio 
ICANS 
Immune effector cell-associated neurotoxicity syndrome 
iCCA 
Intrahepatic cholangiocarcinoma 
ICE 
Immune Effector Cell-Associated Encephalopathy 
ICH 
International Conference on Harmonization 
ICS 
Intracellular cytokine staining 
IFNγ 
Interferon gamma 
IL 
Interleukin 
IND 
Investigational New Drug 
INR 
International normalized ratio 
IRAE 
Immune related adverse event 
IRB 
Institutional Review Board 

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Abbreviation or 
Specialist Term 
Explanation 
iRECIST 
Immune Response Evaluation Criteria in Solid Tumors 
IV 
Intravenous(ly) 
IVD 
In vitro diagnostic 
KRAS 
Kirsten rat sarcoma 
LDH 
Lactate dehydrogenase 
MHC 
Major histocompatibility complex 
mKRAS 
Mutant Kirsten rat sarcoma 
mNRAS 
Mutant neuroblastoma ras viral oncogene homolog 
MRD 
Minimal residual disease 
MRI 
Magnetic resonance imaging 
MSI 
Microsatellite instability 
MTD 
Maximum tolerated dose 
MW 
Molecular weight 
NCCN 
National Comprehensive Cancer Network 
NED 
No evidence of disease 
NGS 
Next-generation sequencing 
NOAEL 
No-observed-adverse-effect level 
NRAS 
Neuroblastoma ras viral oncogene homolog 
NSCLC 
Non-small cell lung cancer 
ORR 
Objective response rate 
OS 
Overall survival 
PBMC 
Peripheral blood mononuclear cell 
pCCA 
Perihilar cholangiocarcinoma 
PCR 
Polymerase chain reaction 
PDAC 
Pancreatic ductal adenocarcinoma 
PE 
Physical examination 
PK 
Pharmacokinetics 
PI 
Primary Investigator 
Poly IC 
Polyinosinic:polycytidylic acid 
PRO 
Patient reported outcome 
PT 
Prothrombin time 

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Abbreviation or 
Specialist Term 
Explanation 
PTT 
Partial thromboplastin time 
QLQ 
Quality of life questionnaire 
QoL 
Quality of Life 
ROA 
Route of administration 
RP2D 
Recommended Phase 2 dose  
RFS 
Relapse-free survival 
SAE 
Serious adverse event 
SARS 
Severe acute respiratory syndrome 
SC 
Subcutaneous 
SEER 
Surveillance, Epidemiology, and End Results 
SMC 
Safety Monitoring Committee  
SOC 
Standard of care 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TEN 
Toxic epidermal necrolysis 
TNFα 
Tumor necrosis factor alpha 
TLR-9 
Toll-like-receptor-9 
ULN 
Upper limit of normal 
US 
United States (of America) 
WES 
Whole exome sequencing 
WFI 
Water for injection 
WT 
Wild type 
XRT 
Radiation therapy 

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4. 
INTRODUCTION 
ELI-002 is a structurally novel amphiphilic therapeutic vaccine being studied as post-surgical 
adjuvant treatment of minimal residual disease (MRD) in subjects with Kirsten rat sarcoma 
(KRAS) viral oncogene homolog mutated pancreatic ductal adenocarcinoma (PDAC) and other 
KRAS mutated solid tumors.  
ELI-002 uses amphiphile lymph node targeting which was developed at the Massachusetts 
Institute of Technology and licensed to Elicio Therapeutics. In cancer subjects, visual 
identification of sentinel lymph nodes during surgery is accomplished by injections of dyes that 
bind to endogenous albumin, targeting these compounds to draining lymph nodes. Amphiphiles 
were developed as an approach to improve the potency and safety of vaccination by harnessing 
the ability of the lipid component to bind to albumin and deliver a payload to lymph node 
antigen-presenting cells (APCs) [Liu et al., 2014]. Initial studies showed that amphiphiles 
markedly increase lymph node accumulation and decrease systemic dissemination relative to 
their parent soluble compounds, leading to 30-fold increases in T-cell priming and enhanced 
anti-tumor efficacy with reduced systemic toxicity. Subsequently investigation of the mechanism 
of action of amphiphiles using Batf3 knockout mice determined that the pharmacology requires 
cross-presenting dendritic cells in lymph nodes, and that combinations of amphiphiles with 
tumor-antigen-targeting antibodies, cytokines, and checkpoint inhibition using PD1 antibodies 
were able to destroy large established transplanted and genetically induced tumors in mice curing 
a majority of cancers in experimental settings previously considered intractable [Moynihan et al., 
2016]. Most recently, amphiphile combinations with chimeric antigen receptor (CAR) T cells 
demonstrated potent enhancement of their activity including modulation of their phenotype to 
increase the proportion of central memory T cells, to extend the longevity of these cells, and to 
confer the ability to induce antigen spreading, which together led to cures of the majority of 
tumors in the models studied [Ma et al., 2019; Singh and June, 2019].  
For the first clinical translation of the amphiphile technology, Elicio is developing ELI-002, a 
mutant KRAS (mKRAS)/mutant neuroblastoma ras viral oncogene homolog (mNRAS) lymph 
node targeting immuno-oncology product candidate. ELI-002 is comprised of up to 
7 lipid-conjugated peptide-based antigens (‘Amph-Peptides’) described in Table 3, and a lipid-
conjugated immune-stimulatory oligonucleotide (‘Amph-CpG-7909’) depicted in Figure 1. 

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Table 3: 
Peptide Elements of Amph-Peptides  
Peptide 
Name 
Peptide Sequencea 
Peptide 
MW (Da)b 
Residuesb 
Amph-Peptide MW 
(Da)b 
G12D 4-21 
CYKLVVVGADGVGKSALTI 
1790 
18 
5049 
G12V 4-21 
CYKLVVVGAVGVGKSALTI 
1774 
18 
5033 
G12R 4-21 
CYKLVVVGARGVGKSALTI 
1831 
18 
5090 
G12A 4-21 
CYKLVVVGAAGVGKSALTI 
1746 
18 
5005 
G12S 4-21 
CYKLVVVGASGVGKSALTI 
1762 
18 
5021 
G12C 4-21 
YKLVVVGACGVGKSALTI 
1778 
18 
4934 
G13D 4-21 
CYKLVVVGAGDVGKSALTI 
1790 
18 
5049 
a Variable residues: aspartic acid (DG and GD); valine (V); arginine (R); alanine (A); serine (S); cysteine (C) 
b Peptide MW and Residues exclude N-terminal cysteine (C) required for Amphiphile sulfhydryl-maleimide 
coupling; Da=Daltons; MW=molecular weight 
 
Figure 1: 
Structure of Amph-CpG-7909 
 
 

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Structurally, each amphiphile (Amph) component is a fusion comprised of 3 domains:  
• Two 18-carbon acyl lipids that mediates association with albumin to facilitate 
trafficking to the lymph nodes and permits cell membrane insertion;  
• A flexible linker that improves pharmaceutical properties in Amph-Peptides; the 
flexible linker is omitted in Amph-CpG-7909;  
• A bioactive peptide or oligonucleotide.  
Results of in vivo preclinical pharmacology studies showed that the greatest T cell responses to 
mKRAS peptides were achieved when the animals were administered Amph-Peptide(s) in 
combination with Amph-CpG adjuvant. The 7 peptide antigens included in ELI-002 have been 
previously evaluated in humans (without amphiphile modification) and were observed to be safe 
and well tolerated after subcutaneous (SC) administration in studies sponsored by Targovax ASA 
[Ericksen et al., 2017; Palmer et al., 2020]. 
ELI-002 targets mKRAS-driven malignancies expressing the most common oncogenic mutant 
forms of KRAS. Upon SC injection, the components of the vaccine are drained from the 
peripheral tissues into the lymph nodes. Here mKRAS Amph-Peptides are taken up by 
antigen-presenting immune cells for processing through the proteasomal pathway. Moynihan et 
al reported that the immunogenicity of peptide vaccines could be increased by maximizing 
delivery to lymph nodes, where T-cell responses generated using the amphiphile approach were 
increased compared to soluble controls [Moynihan et al, 2018] (see Section 4.6.2). 
This protocol, ELI-002-001, describes a First-in-Human trial to evaluate safety and tolerability of 
ELI-002 as adjuvant therapy for subjects with KRAS/NRAS mutated solid tumors. Subjects will 
be treated and evaluated for safety and efficacy of ELI-002 comprised of 1.4 mg Amph modified 
KRAS peptides (0.7 mg per Amph-Peptide) admixed with escalating doses of the Amph 
modified CpG oligonucleotide adjuvant Amph-CpG-7909. The ELI-002 admixture is prepared 
by combining the separately provided products in a diluent prior to dosing. During the Phase 1 
(dose escalation) study, ELI-002 will be comprised of 1.4 mg of 2 Amph modified KRAS 
peptides G12D and G12R admixed with Amph-CpG-7909 to provide ELI-002 2P. Elicio plans to 
investigate the use of an Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, 
G12R, G12V, G12A, G12C, G12S, G13D) admixed with Amph-CpG-7909 (ELI-002 7P) in 
future clinical trials.  
The trial will be monitored in accordance with the Sponsor’s procedures, which comply with the 
ethical principles of Good Clinical Practice (GCP) as required by the major regulatory 
authorities, and in accordance with the Declaration of Helsinki.  
4.1. 
Summary of Pancreatic Cancer and Other Solid Tumors 
4.1.1. 
Pancreatic Cancer 
With an estimated number of 60,430 new cases in the United States (US) in 2021, PDAC is 
among the most common malignancies. Moreover, it is one of the most lethal cancers, as 
indicated by mortality estimated at 48,220 (~80%) [Siegel et al, 2020]. PDAC is the third leading 
cause of cancer death [Siegel et al, 2021], with 133,300 estimated deaths for 2018 in the US and 
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Surgery (pancreatectomy) is the only curative option in PDAC. Even with surgery, prognosis 
remains poor due to the high propensity of the tumor for loco-regional and hepatic recurrence. In 
the National Cancer Database population, the 5-year survival in subjects undergoing 
pancreatectomy was only 23.3% [Sener et al, 1999]. Therefore, surgery alone is clearly an 
inadequate approach to achieve long-term disease control in subjects with resectable PDAC. 
Historical use of adjuvant therapy with gemcitabine, or FOLFIRINOX combination 
chemotherapy improved the disease-free survival (DFS) and overall survival (OS) outcomes for 
subjects with resectable disease, but the majority of these subjects relapsed and died from 
recurrent disease [Conroy et al, 2018; Oettle et al, 2007]. Contemporary neoadjuvant therapy 
with FOLFIRINOX-based neoadjuvant therapy is a standard approach for locally advanced 
pancreatic cancer since it has been shown to improve the surgical resection rates and clinical 
outcomes in locally advanced PDAC [Chawla and Ferrone, 2019], and promising phase 2 data 
with neoadjuvant gemcitabine/nab-paclitaxel [Philip et al, 2020] indicate that an alternative 
regimen has activity. Fluoropyrimidine-based chemoradiation may be used as well [NCCN 
PDAC guidelines Version 1.2022]. Despite this, there is a need for improved adjuvant therapies 
for subjects who have undergone pancreatic resection surgery as survival rates for pancreatic 
cancer have mostly remained unchanged since the 1970s [Ansari et al, 2016; Macdonald and 
Mair, 2016].  
PDAC is a disease that is almost entirely related to KRAS mutations. The KRAS gene encodes the 
KRAS protein, which is a small (21 kDA) guanosine triphosphatase (GTPase) that functions as a 
simple binary ON–OFF molecular switch, cycling between active GTP-bound and inactive 
guanosine diphosphate (GDP)-bound states [Vigil et al, 2010]. Cancer-associated RAS genes 
contain missense mutations that encode single amino acid substitutions primarily (98%) at 1 of 3 
mutational hot spots: glycine-12 (G12), glycine-13 (G13), or glutamine-61 (Q61) [Waters and 
Der, 2018]. These mutations render KRAS persistently GTP-bound and constitutively active, 
resulting in overstimulation of effector signaling pathways to drive cancer growth.  
The majority of KRAS mutations occur at codon 12. A conversion of the amino acid glycine (G) 
to aspartic acid (D) at this site (KRAS G12D) is the most frequent KRAS mutant in human 
gastrointestinal cancers and has been identified in approximately 33% to 52% of pancreatic 
cancers [Biankin et al 2012; Hendifar et al 2020; Guo et al 2020] and 34% to 37% of CRCs 
[Gong et al 2017; Prior et al, 2012; Price et al, 2020]. KRAS G12D plays a vital role in the 
control of tumor metabolism [Vigil et al, 2010].  
In addition to G12D, there are 5 other clinically relevant but less frequently identified mutants 
with amino acid substitutions at the same site (G12V, G12R, G12A, G12S, and G12C) and 1 
peptide with a mutation at codon 13 (G13D). After G12D, G12V mutation is the next most 
frequent mutation in PDAC, identified in about 36% of these tumors, followed by G12R (about 
12% of mutations) [Biankin et al, 2012]. The remaining codon 12 mutations (G12A, G12C, and 
G12S) each account for about 3% to 4% of PDAC-associated codon 12 KRAS mutations [Prior 
et al, 2012]. G13D is the most frequent codon 13 mutation but is only identified in <1% of 
PDAC tumors. 
Administration of a combination of these peptides provides coverage for multiple potential 
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Circulating tumor deoxyribonucleic acid DNA (ctDNA) is a promising biomarker in the 
management of many cancers, including breast, colorectal [Bettegowda et al, 2014; Reinert et al, 
2019; Tie et al, 2016; Tie et al, 2019], non-small cell lung cancer (NSCLC) [Abbosh et al, 2017], 
bile duct [Jensen et al, 2020], and pancreatic cancers [Diaz and Bardelli, 2014; Lee, Lipton, et al, 
2019]. 
In the metastatic setting, PDAC subjects with positive MRD, as measured by mKRAS ctDNA 
exhibit shorter OS [Perets et al, 2018]. Presence of MRD pre-surgery predicted for poor 
outcomes. Similarly, measurement of mKRAS ctDNA identifies PDAC subjects who have 
undergone pancreatectomy but are at high risk of recurrence. For example, persistence of ctDNA 
immediately following the postoperative period was associated with a high rate of recurrence and 
shorter median recurrence-free survival (5 months) than those without detectable postoperative 
ctDNA (15 months) [Groot et al, 2019]. Similar data were obtained by analysis of a prospective 
cohort in Australasia who underwent surgery and adjuvant gemcitabine-based chemotherapy; 
ctDNA 4-8 weeks post-surgery was assessed [Lee, Lipton, et al., 2019]. In this study, ctDNA 
detection post-surgery had 100% positive predictive value at a median follow-up of 38.4 months; 
ctDNA predicted relapse free (hazard ratio [HR]: 5.4; 95% confidence interval [CI]: 1.9-15.2; 
p<0.0001). Likewise, high pre-operative ctDNA levels associated with shorter overall survival 
(HR: 2.8, 95% CI: 1.8-4.6, p = 0.001) and were an independent prognostic factor compared to 
pathologic features of pancreatic cancer in multivariate analysis of an operable pancreatic cancer 
patient cohort [Singh et al., 2015]. Subjects who remain ctDNA positive despite chemotherapy 
and successful resection are therefore a high-risk population. 
Likewise, multiple studies have shown the prognostic value of postsurgical serum carbohydrate 
antigen 19-9 (CA19-9), with failure to normalize correlating with early recurrence. Most patients 
are assessable for CA19-9, with the exception of 5-10% of the population who lack Lewis blood 
antigen expression and cannot synthesize the sialylated carbohydrate. For example, in a 
retrospective analysis of 525 patients, postsurgical elevations in CA19-9 predicted subsequent 
radiographic relapse [Rieser et al., 2018]. In a Japanese cohort of 119 patients who completed 
adjuvant chemotherapy, median relapse-free survival (RFS) was significantly shorter in patients 
with CA19-9 above the upper limit of normal (ULN) versus those with lower levels (10.4 vs 
29.6 months, p<0.001), median overall survival was also shorter (24.7 vs 92.1 months; p<0.001), 
and CA19-9 was an independent prognostic factor (HR: 2.72) associated with short RFS [Imaoka 
et al., 2016]. Prospective studies have also found that postoperative CA19-9 predicts overall 
survival: among 385 RTOG9704 patients, those with a CA19-9 ≥90 U/mL had a 3-year survival 
of 2%, whereas those with CA19-9 <90 U/mL had a 3-year survival of 32% [Berger et al., 2008]. 
In Protocol ELI-002-201, subjects in the Phase 1 cohort will be enrolled based on high risk 
ctDNA or serum tumor biomarkers. 
Activating KRAS mutations turn on canonical cancer-related pathways but also contribute to 
extensive metabolic reprogramming of pancreatic cancer cells. KRAS is mutated in >90% of 
PDACs and is a well-validated driver of not only initiation but also PDAC growth and 
maintenance [Eser et al, 2014]. Recently, FDA approval of small molecules targeting KRASG12C 
such as Sotorasib [Hong et al., 2020] suggest it may be possible to target cysteine containing 
KRAS alleles, however G12D and G12V are predominate in pancreatic cancer, and non G12C 
alleles are also common in colorectal and NSCLC, making it clear that additional 
immunotherapy strategies are urgently needed.  

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In a small trial from Norway, Palmer et al utilized a vaccine containing the same mKRAS 
peptides present in ELI-002. Prolonged survival was observed in one quarter (8 of 32) of the 
pancreatic cancer subjects that underwent resection surgery and were immunized; this trial also 
provided evidence that humans can mount T-cell responses against KRAS peptides and 
established a dosing schedule that was the basis for the design of the ELI-002-001 trial [Palmer 
et al, 2020]. Thus, KRAS directed vaccines represent a promising strategy to target this lethal 
cancer.  
ELI-002 is well suited to pancreatic cancer since it covers common mutations in KRAS that are 
present in the majority of pancreatic adenocarcinoma cases. A large comprehensive trial of 
3,594 pancreatic tumor samples submitted for analysis at Foundation Medicine (Cambridge, 
MA) has recently been published [Singhi et al, 2019]. In this analysis 3,150 of the 3,594 (88%) 
tumors harbored an mKRAS allele. Similar high prevalence of mKRAS was evident in the 
international consortium trial of US, Australian, and Canadian pancreatic tumors where 93% of 
142 tumors had exon 2 mutations (Table 4); 46% were G12D, 36% were G12V, and 12% were 
G12R [Biankin et al, 2012]. The proportion and specific mKRAS alleles identified are consistent 
across studies, as confirmed by the Cancer Genome Atlas Network, where 93% (140 of 150) 
tumors harbored mKRAS including 44% that were G12D, 29% that were G12V, and 20% that 
were G12R [Cancer Genome Atlas Network et al, 2017]. Likewise, the Johns Hopkin’s cohort 
identified KRAS mutations in 96% (49 of 51 pancreatic tumors), with 42% G12D, 27% G12V, 
21% G12R, 6% G13D and 2% G12C [Sausen et al., 2015] and a German trial identified KRAS 
mutations in 79% (141 of 179 pancreatic tumors); 49% were G12D, 34% G12V, 14% G12R and 
2% G12C [Haas et al, 2017].  
Therefore, the majority of pancreatic cancer subjects are anticipated to have a KRAS mutation 
appropriate for ELI-002-001 trial participation. KRAS is a validated oncogene that when 
mutated is required for PDAC growth and maintenance so that target loss is not anticipated. 
Enhancing the T-cell immune response to PDAC by utilizing the targeted KRAS ELI-002 
product candidate has the potential to improve the outcomes of subjects who have undergone 
pancreatic resection surgery. 
Table 4: 
KRAS Mutation Spectrum in Pancreatic Cancer 
 
G12D 
(%) 
G12V 
(%) 
G12R 
(%) 
G13D 
(%) 
G12C 
(%) 
G12A 
(%) 
G12S 
(%) 
Reference: 
Pancreatic 
46 
36 
12 
0 
0 
0 
0 
Biankin et al, 2012 
Pancreatic 
42 
27 
21 
6 
2 
0 
2 
Sausen et al, 2015 
Pancreatic 
49 
34 
14 
nr 
2 
nr 
nr 
Haas et al, 2017 
Pancreatic  
44 
29 
20 
nr 
nr 
nr 
nr 
Cancer Genome 
Atlas Network, 2017 
Pancreatic 
33 
23 
11 
nr 
1 
nr 
nr 
Hendifar et al, 2020 
Pancreatic 
52 
28 
12 
4 
4 
0 
0 
Guo et al, 2020 
 

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4.1.2. 
Colorectal Cancer 
4.1.2.1. 
Introduction 
Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading 
cause of cancer death in the US. In 2018, 97,220 new cases of colon cancer and approximately 
43,030 cases of rectal cancer have been diagnosed. During the same year, an estimated 50,630 
people died of colon and rectal cancers combined [Miller et al; 2019; Siegel et al, 2020]. 
Non metastatic colon cancer is generally treated with curative intent by colectomy and, in many 
cases, adjuvant chemotherapy. The prognosis for patients with CRC depends on the stage at 
diagnosis: the 5-year survival rate is up to 90% for stage I, but only <15% for advanced stages. 
Over half of the cases are diagnosed at a higher stage of disease (III and IV). Treatment usually 
involves the complete primary tumor resection and appropriate chemotherapy.  
4.1.2.2. 
Adjuvant Therapy in the Case of Localized CRC Disease 
Adjuvant therapy confers a survival advantage in patients with stage III or high-risk stage II 
resected colon cancer. High risk stage II colon cancer are defined as stage T4 tumor, poor 
differentiation, cancer embolus, lymph node harvested number less than 12 and obstruction or 
perforation, baseline carcinoembryonic antigen (CEA) >5 ng/L, large vessel invasion, perineural 
invasion, and extramural vascular invasion [Amri et al, 2016]. 
For patients with high-risk stage II or stage III colon cancer, adjuvant chemotherapy with 
fluoropyrimidine and oxaliplatin reduces the risk of recurrence and death by approximately 30%. 
Oxaliplatin is associated with peripheral neurotoxicity. Consideration of disease stage and 
pathologic features, microsatellite instability (MSI) status, toxicity profiles, and patient age, 
comorbidities, aid in decision-making regarding the use of adjuvant therapy. 
The National Comprehensive Cancer Network (NCCN) guidelines are based on the IDEA study, 
published in 2018, an academic collaboration of clinicians and statisticians who were involved in 
6 randomized, Phase 3 clinical trials enrolling in 12,834 patients with stage III colon cancer in 
12 countries. The 3-year rates of DFS were 74.6% in the 3-month adjuvant therapy group as 
compared with 75.5% in the 6-month therapy group. The 3-year rates of DFS were 64.4% in 
high-risk patients: T4 (61.8%), or N2 (61.4%) [Grothey et al, 2018].  
Tumor (T) and nodal (N) stage were grouped together to make a pragmatic choice between 
low-risk (T1–T3,N1) and high-risk (T4 and/or N2). A difference of approximately 20% at 
3 years was shown between these cancers.  
According to the NCCN Guidelines for patients with low-risk stage III disease (T1–3,N1), the 
preferred regimen is CAPEOX for 3 months or FOLFOX for 3 to 6 months. For patients with 
high-risk stage III disease (T4,N1–N2 or any T and N2), the preferred regimen is CAPEOX for 
3 to 6 months or FOLFOX for 6 months. Other options include capecitabine (6 months) and 
5-fluorouracil (5-FU) for 6 months [Grothey et al, 2018]. 
After adjuvant cytotoxic therapy, no further treatment is recommended. Circulating tumor DNA 
is positive in 28.6% defining a subgroup of high-risk Stage II (T4N0) and a 39.4% subgroup of 
high-risk Stage III (T4, N1 or T Any, N2) patients [Kasi et al, 2020]. 

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4.1.2.3. 
Rectal Cancer 
Patients with rectal cancer were specifically excluded from these studies because of potential 
toxicity and the confounding impact of radiotherapy. 
Although conclusive data on the benefits of adjuvant therapy in patients with stage II/III rectal 
cancer are lacking, the NCCN panel recommends its use. Choice of regimen depends on initial 
clinical staging and predicted circumferential resection margin status during excision surgery 
(such as total mesorectal excision). Pathologic evaluation of the resection margin on the excised 
rectum has been considered important for determining the risk of local recurrence. A margin of 
≤1 mm is considered by some to be a negative prognostic factor for local recurrence [Benson et 
al, 2018]. 
FOLFOX or CAPEOX are preferred adjuvant regimens, with 5-FU/leucovorin or capecitabine 
used in some circumstances, such as when strong neoadjuvant responses to 5-FU or capecitabine 
were previously obtained during therapy. Neoadjuvant or adjuvant 5-FU or capecitabine-based 
chemoradiation, or total neoadjuvant therapy are all standard options for rectal cancer [NCCN 
rectal cancer guidelines V1.2022]. 
4.1.2.4. 
Colorectal Liver Metastases  
Aside from localized CRC, up to 25% of patients with CRC present with simultaneous 
metastases and the liver is frequently the only metastatic site.  
Approximately 35% to 55% of patients will develop hepatic metastases during the course of their 
disease. In some cases, colorectal liver metastases are resectable, ie, an R0 resection can be 
performed, leaving at least a 20% to 25% of total liver volume as future liver remnant. Surgical 
resection represents the only chance of long-term survival [Akgul et al, 2014]. 
Preoperative factors found to be independent predictors of poor survival are a primary tumor at 
stage T4, ≥4 liver metastases, the largest liver metastasis ≥5 cm in diameter, and a serum CEA 
level ≥5 ng/mL. According to these factors, resectable patients could be divided in high-risk 
patients (3 or more factors) and low-risk patients (less than 3 factors) [Adam, et al, 2012]. 
The optimal sequencing of systemic therapy and resection in colorectal liver metastases remain 
unclear. Most studies report on perioperative (neoadjuvant plus postoperative) systemic therapy 
[Krell et al, 2019], with some series reporting on patients with resectable disease who undergo 
resection first, followed by postoperative adjuvant chemotherapy. 
A 2012 meta-analysis identified 3 randomized clinical trials comparing surgery alone to surgery 
plus systemic therapy. The analysis showed a benefit of chemotherapy in progression-free 
survival and DFS but not in OS. Another meta-analysis combined data on 1,896 patients and also 
found that perioperative chemotherapy improved DFS but not OS [Ciliberto et al, 2012]. 
In high-risk patients, perioperative combination chemotherapy should be administered. Those 
who had received neoadjuvant chemotherapy had a better median OS (38.9 months versus 
28.4 months) than those had not received it, and 5 years OS rate of 39% versus 33% (p=0.028). 
In low-risk patients, no significant difference in median survival (60.0 m versus 60.0 m) was 
observed. 

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Colorectal metastatic disease sometimes occurs in the lung. Complete resection based on the 
anatomic location and extent of disease with maintenance of adequate function is required. Most 
of the treatment recommendations for metastatic colorectal liver disease also apply to the 
treatment of colorectal pulmonary metastases. 
Colon, rectal, and oligometastatic CRC patients who show minimal residual DNA on ctDNA 
analysis with no radiographic evidence of disease following prior surgery and 
neoadjuvant/adjuvant chemotherapy, will be eligible to participate in this protocol. 
4.1.2.5. 
Frequency of KRAS and NRAS Mutations in CRC 
KRAS genotyping is done for every CRC patient because of its impact on the treatment and 
patients are classified as KRAS wild type (WT) or KRAS mutated. 
Since 2008, anti-epidermal growth factor receptor (EGFR) therapy is restricted to KRAS WT 
patients as it has been shown that KRAS mutated tumors do not respond [Boeckx et al, 2015; 
Modest et al, 2016]. 
KRAS mutations occur in approximately 40% of the cases, especially in exon 2, codons 12 
(70%-80%) and 13 (15%-20%) (Table 5) [Gong et al, 2017; Zhang et al, 2015; Prior et al, 2012; 
Price et al, 2020]. In exon 2, mutations are common in codons 12: G12D, G12V, G12C and 
G12A. Much less frequent KRAS mutations are mainly located in exon 3, codons 59–61, and in 
exon 4, codons 117 and 146 [Afrasanie et al, 2019]. 
Since the amino acid sequence surrounding positions 12 and 13 are identical in KRAS and 
NRAS, T cells generated to these mKRAS epitopes cross-react and are effective in targeting 
mNRAS at the same amino acids [Chatani and Yang, 2020]. NRAS mutations also occur in CRC 
in approximately 4% of cases, also in exon 2, codons 12 and 13 [Douillard et al, 2013; Summers 
et al, 2017; Zhang et al, 2015]. Therefore, ELI-002 can additionally target NRAS mutations at 
positions 12 and 13. 
Table 5: 
Colon and Rectal Cancer KRAS and NRAS Mutation Spectrum 
 
G12D 
(%) 
G12V 
(%) 
G12R 
(%) 
G13D 
(%) 
G12C 
(%) 
G12A 
(%) 
G12S 
(%) 
Reference 
KRAS 
Colon  
34 
12 
0 
7 
0 
1.4 
5.1 
Gong et al, 2017 
Colon  
41 
20 
0.7 
20 
6 
3.6 
8 
Zhang et al, 2015 
Colon  
35 
20 
0.9 
19 
10 
6 
7 
Prior et al, 2012 
Colon 
37 
23.6 
Nr 
13.3 
9.6 
10.7 
4.4 
Price et al, 2020 
Rectal 
33 
23 
0.7 
17 
8 
7 
6 
Prior et al, 2012 
NRAS 
Colon 
45 
14 
nr 
nr 
14 
4 
nr 
Douillard et al, 2013 
Colon 
25 
13 
nr 
nr 
62.5 
nr 
nr 
Summers et al, 2017 
Colon 
52 
4 
nr 
9 
13 
nr 
nr 
Zhang et al, 2015 
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The full analysis of the RAS gene exons 2, 3, and 4 revealed that these mutations correlate with 
certain typical clinical, pathological and molecular features. The mutations of exon 2 and codon 
12 are associated with the well/ moderately differentiated adenocarcinoma subtype and the 
mucinous subtype [Dobre et al, 2015]. 
Limited data is available evaluating the possible prognostic role of mKRAS at the initiation of 
the treatment. One study showed that patients with KRAS mutation who presented with stage IV 
had a higher mortality rate (34% versus 18.5%) and reduced OS (23.5 months versus 14 months) 
compared to patients without this mutation. Also, the presence of the KRAS mutation was found 
to be an independent risk factor for reduced survival [Heinemann et al, 2009].  
4.1.2.6. 
Importance of ctDNA and CEA Assessment and Follow-up in CRC 
Different authors reported that the detection of ctDNA in CRC patients with stage I, II, or III 
after treatment was associated with a shorter survival and disease recurrence. Patients with 
higher levels of mutant ctDNA and higher mutation loads for the detected mutations 
in KRAS or BRAF genes evinced shorter OS. Diehl et al observed that CRC patients with 
detectable ctDNA after surgery generally relapsed within 1 year and considered ctDNA as a 
highly specific biomarker of tumor dynamics. This might indicate that ctDNA levels in plasma 
after surgery represent a reliable marker of residual disease [Diehl et al, 2008]. Subsequent 
studies have now confirmed the utility of serial ctDNA sampling for relapse prediction. Reinert 
et al observed a 2 to 15 (mean 10) months lead time on detection of metastatic recurrence 
compared to conventional follow-up [Reinert et al, 2016].  
These all support the further development of ctDNA as a biomarker for the detection of early 
diseases and MRD following curative resection, relapse assessment, treatment response, and the 
development of chemoresistance [Vymetalkova et al, 2018]. Fan et al systematically reviewed 
comprehensive data from published studies and showed that a ctDNA-positive status after 
treatment was associated with a worse prognosis [Fan et al, 2017].  
In addition, ctDNA assessment using a personalized ctDNA method for 535 colon cancer 
patients in a real-world sample have confirmed the association with relapse and allow precise 
definition of the risk subgroups. High risk stage 2 (T4N0 with MRD rate 28.6%), high risk stage 
3 (T4N1-2; TanyN2 with MRD rate 39.4%) and surgically resected oligometastatic patients 
(MRD rate 49%) have high rates of ctDNA detection indicating their unmet need for effective 
therapy [Kasi et al 2020]. In a prospective, multicohort study [Tarazona et al, 2020] with 84 
patients where MRD+ status after adjuvant chemotherapy was determined using a personalized 
ctDNA assay, all MRD+ patients relapsed and the association was strongly statistically 
correlated (HR: 27.9; 95% CI: 9.2-85.1 months; p<0.0001). Another study in a cohort of 230 
patients with Stage II colon cancer further confirmed that a plasma-based ctDNA analysis 
predicts recurrence [Tie et al, 2016]. Patients who were ctDNA positive postoperatively were at 
extremely high risk of radiologic recurrence (HR 18) and ctDNA positivity immediately after 
completion of chemotherapy was associated with poorer RFS (HR 11). Postsurgical ctDNA 
analysis using a plasma-based ctDNA assay in 100 patients with Stage III colon cancer 
demonstrated that MRD+ status was associated with inferior RFS [Tie et al, 2019].  
Likewise, the association between elevations in serum CEA with relapse following surgery and 
adjuvant chemotherapy in colorectal cancer was examined in a large patient series. The 

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CEAwatch study, consisting of 3223 patients with Stage I-III R0 resected CRC in the 
Netherlands, evaluated recurrence outcomes in patients followed with usual care versus patients 
with intensified follow-up, including CEA monitoring every 8 weeks, with more frequent 
monitoring if the CEA value was >2.5 ng/mL or if there was a 20% increase compared with the 
previous value. The results showed that with the intensified follow-up protocol a significantly 
higher proportion of radiographic relapse was detected compared with usual care (odds ratio: 1.8; 
95% CI: 1.33-2.50; p=0.0004), indicating earlier detection [Verberne et al., 2015; Verberne et 
al., 2017]. A Memorial Sloan Kettering review of 728 R0 resected patients showed that 
individual CEA measurements above a threshold of 15 ng/mL had a low (2%) false positive rate, 
and no elevations above 35 ng/mL were false positive [Litvak et al., 2014]. 
ELI-002 will be evaluated in such MRD+ patients and those with successive rises in 
CEA/elevated CEA above 15 ng/mL.  
4.1.2.7. 
Colorectal Cancer and Vaccines 
Approaches under investigation to further improving therapy are vaccinations with peptides 
alone, peptide-expressing viruses, peptide-loaded APCs or application of peptide-specific 
T cells.  
In the process of cancer development mutations resulting in neoantigens can emerge in every 
coding region of the DNA. Neoantigens caused by KRAS are one example for point mutations in 
CRC. Early approaches could prove that peptides derived from mKRAS can stimulate cytotoxic 
T-lymphocytes in vitro [Gedde-Dahl, 1994] as well as in CRC [Shono et al, 2003]. A subsequent 
study also investigated the cytotoxic activity of mKRAS peptide-induced cytotoxic 
T lymphocytes [Khleif et al, 1999]. Only 2 of 10 CRC patients showed induction of 
peptide-specific CD8+ but in addition, these cytotoxic T cells were able to lyse HLA-A2-positive 
target cells incubated with the 10-mer mutant peptide. Similar results were obtained in a 
xenograft study, where peptide-specific T cells were able to delay the growth of KRAS-mutant 
pancreatic tumors [Wang, et al, 2016]. 
In vaccination trials with peptides derived from mKRAS, there were early indications of 
potential clinical benefits for patients. Two of 7 CRC patients had an immune response to a 
mKRAS peptide vaccine, and vaccination correlated to DFS [Toubaji et al, 2008]; the treatment 
was well tolerated with no serious systemic effects and Grade 1 to 2 reactogenicity. One of 4 GI 
tumor patients, an individual with CRC, exhibited induction of G12D-specific T cells in response 
to mRNA vaccine administration [Cafri, et al., 2020]. In a case report, 1 CRC patient was treated 
with activated T cells recognizing G12D KRAS [Tran, et al, 2016]. After a single infusion, all 7 
lung metastases regressed until 1 metastatic lesion progressed at 9 months. This patient 
underwent surgical resection for the single relapsed site and has now been in ongoing remission 
for >4 years [Chatani and Yang, 2020]. 
To further enhance the immunological response in CRC patients, Rahma et al combined the 
peptide vaccination of mKRAS with IL-2 or granulocyte-macrophage colony-stimulating factor 
(GM-CSF) [Rahma, 2014]. The strongest immune response could be detected in the group with 
GM-CSF as adjuvant; all CRC patients had an increase in interferon gamma (IFN) producing, 
specifically-activated T cells. Despite the high immune response rate, none of these advanced 
metastatic patients showed clinical response and disease progressed in all cases. 

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4.1.3. 
Non-small Cell Lung Cancer 
NSCLC is the leading cause of cancer mortality in the United States, with an estimated incidence 
in 2021 of over 235,000 and estimated deaths of over 131,000 [Siegel et al., 2021]. While 
surgically treated patients with Stage 1A enjoy long-term disease-free survival, relapse is 
common following surgery for Stage 1B, II, or IIIA disease, with 30%, 60%, and 75% mortality 
[Ravdin 2006]. However, neither adjuvant chemotherapy [Strauss et al., 2008] nor radiation 
therapy [PORT Meta-analysis Trialists Group, 2005] improves overall survival for IB tumors. 
For Stage II tumors, meta-analysis of multiple trials [Pignon et al., 2008] supports a modest 
adjuvant chemotherapy benefit (HR 0.89, 95% CI, 0.82–0.96; p= 0.005); similar benefit was 
observed in neoadjuvant meta-analysis [Burdett et al., 2007], and radiation appears to shorten 
rather than benefit survival outcome [PORT Meta-analysis Trialists Group, 2005]. For Stage IIIA 
tumors, both neoadjuvant [Burdett et al., 2007] and adjuvant [Pignon et al., 2008] chemotherapy 
confer modest benefit. Immunotherapy with checkpoint inhibition using durvalumab was 
associated with longer progression-free survival in NSCLC patients following chemoradiation, 
with a median 16.8 versus 5.6 months (HR 0.52, 95% CI 0.42-0.65, p <0.001) [Antonia et al., 
2017]. Similarly, in a Phase 3 trial of 1005 NSCLC patients following complete surgical 
resection and adjuvant platinum-based chemotherapy whose tumors expressed PD-L1 on 1% or 
more of tumor cells, patients randomized to atezolizumab had not reached the median disease-
free survival compared with best supportive care where the median was 35.3 months (HR: 0.66; 
95% CI 0.50-0.88; p=0.0039) [Felip, et al., 2021]. In addition, nivolumab was approved by the 
FDA for neoadjuvant therapy of NSCLC based on the randomized Checkmate-816 trial which 
compared 3 cycles of combined nivolumab/platinum-based chemotherapy versus platinum based 
chemotherapy alone; the median event-free survival was 31.6 months versus 20.8 months (HR: 
0.63; p=0.0052) [FDA Press Release]. Since immunotherapy appears to be more active in 
NSCLC, novel agents like ELI-002 with an immune mechanism of action hold promise to 
improve outcomes in NSCLC. 
Therefore, ELI-002 will be studied in patients with KRAS-mutated NSCLC who have completed 
neoadjuvant or adjuvant chemotherapy, chemoradiation, or checkpoint inhibitor therapy, as 
appropriate for their stage of tumor, when they remain ctDNA positive indicating a high risk for 
relapse. 
4.1.3.1. 
KRAS Mutations in NSCLC 
Tumor genetics is assessed as standard of care to detect actionable mutations in ALK, ROS1, 
EGFR, NTRK and BRAF, and KRAS is frequently included in the DNA sequence methods. 
KRAS mutations (Table 6) are present in approximately 26% of NSCLC patients [Dogan et al., 
2012], with a high proportion of G12C alleles (Table 6); NRAS mutations are very rare [Illei et 
al., 2017]. 
Table 6: 
KRAS Mutation Spectrum in Non-small Cell Lung Cancer 
 
G12D 
(%) 
G12V 
(%) 
G12R 
(%) 
G13D 
(%) 
G12C 
(%) 
G12A 
(%) 
G12S 
(%) 
Reference 
NSCLC 
17 
21 
nr 
nr 
39 
11 
nr 
Dogan et al., 2012 
NSCLC 
17 
21 
2 
2 
41 
8 
4 
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4.1.3.2. 
Circulating Tumor DNA in NSCLC 
The TRACERx (Tracking Non-Small-Cell Lung Cancer Evolution Through Therapy [Rx]) study 
demonstrated the ability of a personalized ctDNA assay to detect MRD post-operatively in 
patients with non-small cell lung cancer [Abbosh et al., 2017]. Additionally, ctDNA kinetics 
reflected the tumor response to treatment, and predicted a patient’s early cancer recurrence 
before relapse could be detected via standard imaging studies. Consistent results were observed 
in a smaller single-center study of 37 NSCLC patients, where detection of ctDNA within 
4 months of completion of locoregional therapy for Stage 1B-III tumors was associated with 
poor freedom-from-progression and disease-specific survival [Chaudhuri, et al., 2017]. 
Reduction from baseline of <50% in ctDNA level was significantly associated with disease 
progression (HR: 2.28; p= 0.013) in a cohort of 99 metastatic NSCLC patients undergoing PD-
L1 checkpoint inhibitor therapy [Nabet, et al., 2020]. Therefore, additional effective therapies are 
needed for ctDNA positive NSCLC patients who have a high risk of relapse following surgery 
and adjuvant/neoadjuvant therapy; post-baseline reductions in ctDNA holds promise as a 
potential early endpoint. 
4.1.4. 
Ovarian Carcinoma 
Ovarian cancer, associated with primary peritoneal cancer and cancer of the Fallopian tube, is the 
leading cause of gynecologic cancer death in developed countries and most often presents at an 
advanced stage. At diagnosis, 80% of patients present with stage 3 and 10% with stage 4. The 
5-year survival rate is approximately 30%. 
During 2021, the American Cancer Society estimates that approximately 21,410 women will be 
diagnosed with ovarian carcinoma, and approximately 13,770 patients will die as a result of the 
disease [Siegel et al, 2021]. Worldwide, 295,414 new patients per year (2018), and 
184,799 deaths [Bray et al, 2018]. Ovarian cancer is the second most common cancer of the 
female genital tract. In the US, it is responsible for more cancer deaths than all other gynecologic 
tumors. 
The prevalence is approximately 10 times its incidence, with Surveillance, Epidemiology, and 
End Results (SEER) data estimating 233,364 women in the US living with the disease in 2017 
[SEER, 2020]. A paucity of symptoms indicative of early disease, coupled with the absence of 
validated screening tools, makes ovarian carcinoma the deadliest of the gynecologic 
malignancies, with 10-year DFS rate less than 10%.  
Malignant epithelial tumors are the most common type of ovarian cancer and comprise almost 
90% of cases, with the remainder comprised of low-grade borderline tumors. The treatment of 
ovarian cancer has been based mainly on tumor grade and stage, but the histologic subtype is 
very important in-patient management.  
Most patients have advanced disease at initial diagnosis: primarily stage III (75-80%), and fewer 
stage IV (5-10%). Regardless of tumor type, the estimated 5-year OS according to the 26th 
International Federation of Gynecology and Obstetrics annual report is 50% to 65% for stage III 
and 20% to 25% for stage IV.  
The current standard-of-care for the treatment of this majority of patients involves cytoreductive 
surgery and platinum-based chemotherapy. The NCCN Ovarian Cancer guidelines (Version 
1.2022) include as preferred chemotherapy regimens for ovarian cancer. These are paclitaxel 

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175/carboplatin, as well as 5-FU/leucovorin/oxaliplatin with or without bevacizumab, or 
capecitabine/oxaliplatin with or without bevacizumab. 
Although approximately 80% of patients achieve complete clinical response through extensive 
cytoreductive surgery and platinum- and taxane-based chemotherapy, most ultimately develop 
recurrent chemo-resistant disease. 
Therapeutic options for patients in complete response following combined modality therapy 
depend on the primary chemotherapy regimen used, and the BRCA1/2 mutation status. Poly 
(ADP-ribose) polymerase inhibitors are effective in the BRCA1/2 mutated subpopulation of 
tumors [Armstrong et al, 2020; Boussios et al, 2019]. 
• Patients who are in clinical remission, defined as no evidence of disease, after 
primary chemotherapy without bevacizumab have several options:  
1. Investigational therapy such as ELI-002 in the context of a clinical trial 
2. Observation  
3. Olaparib or niraparib for those with a BRCA1 or BRCA2 mutation 
Therefore, ELI-002 will be evaluated in the population whose tumors lack mutation in BRCA1/2 
who are in clinical remission after primary chemotherapy. 
4.1.4.1. 
Ovarian KRAS Mutations  
Tumor molecular testing is frequently performed in ovarian cancer to assess for BRCA1/2 
mutation, and KRAS is often included. KRAS mutations (Table 8) are present in primary tumors 
at 9.6% to 12.5% of serous, 11.76% to 33% of endometrioid, 43.6% to 61% of mucinous, and 
14% to 26.3% of clear cell histologies [Auner et al, 2009; Morikawa et al, 2018; Perren, 2016; 
Rechsteiner et al, 2013; Dobrzycka et al, 2011]. Borderline tumors may harbor KRAS mutations 
but have a favorable prognosis [Prat et al, 2018; Rambau et al, 2017]. The spectrum of mutations 
in ovarian cancer is similar to gastrointestinal tumors with the most frequent mutation being the 
G12D allele (Table 7). NRAS mutations are rare in ovarian tumors. 
Table 7: 
KRAS Mutation Spectrum in Ovarian Tumors 
 
G12D 
(%) 
G12V 
(%) 
G12R 
(%) 
G13D 
(%) 
G12C 
(%) 
G12A 
(%) 
G12S 
(%) 
Reference: 
Ovarian 
40 
23 
3 
7 
13 
7 
0 
Auner et al, 2009 
 

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Table 8: 
KRAS Mutation Frequency in Ovarian Tumors 
Subtype of Ovarian Carcinoma 
KRAS Mutation Frequency (%) 
High-grade serous  
9.6-12.5 
Low-grade serous  
29.5 
Mucinous  
43.6-61  
Clear Cell 
14-26.3 
Endometrioid 
11.76-33 
Mucinous Borderline 
33-78  
 
4.1.4.2. 
Circulating Tumor DNA in Ovarian Cancer  
Promising data using ctDNA methods have been observed that demonstrate that MRD+ status 
following chemotherapy predicts short time to disease progression [Kim et al, 2019; 
Giannopoulou et al, 2018]. In addition, biochemical relapse of ovarian cancer (as determined by 
CA-125 serum concentrations >35 U/mL) predated radiographic progression by approximately 
4.5 months in a cohort of 98 Dutch patients [van der Burg et al., 1990]. Therefore, ELI-002 will 
be evaluated in ovarian cancer patients with KRAS mutations who are ctDNA positive following 
therapy and those who are at high relapse risk due to serum CA-125 tumor biomarker above the 
normal range. 
4.1.5. 
Cholangiocarcinoma  
Cholangiocarcinomas (CCAs) are rare and aggressive tumors. About 8,000 patients are 
diagnosed with CCA each year in the US. In 2016, there were 7,000 new patients in the US and 
5,600 deaths [Yao et al, 2016]. An increasing incidence has been reported worldwide since the 
last 10 years, especially the intrahepatic subtype: the number of intrahepatic cholangiocarcinoma 
(iCCA) has more than doubled and the global mortality rate has increased to 36% [Kirstein et al, 
2016].  
CCAs are one of the most fatal cancers: although 1-year mortality has improved over time, the 
5-year survival is still as low as 10%. The only curative option for patients with CCA is surgical 
resection, but many patients are diagnosed with distant disease, and 10% to 45% of those 
considered appropriate for surgery are found to be unresectable at laparotomy [Blechacz et al, 
2017]. At advanced stage, CCA has a devastating prognosis with a median OS of only 12 to 
15 months. 
CCAs are diverse biliary epithelial tumors involving the intrahepatic, perihilar, and distal biliary 
tree. They are categorized according to anatomical location as iCCA, perihilar 
cholangiocarcinoma (pCCA), or distal cholangiocarcinoma (dCCA). The 5-year survival rates 
are: intrahepatic 21% to 40%, perihilar 10% to 37%, distal 23% to 45% [Blechacz et al, 2017]. 
For patients with advanced-stage or unresectable CCA, first-line systemic therapy with cisplatin 
and gemcitabine provides a survival advantage over gemcitabine alone [Valle et al, 2010]; 
however, there is limited effectiveness: median OS with the standard regimen is less than 1 year 
[Rizvi et al, 2018], and there is no standard for later-line therapy. 

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In the adjuvant setting, there was no adjuvant benefit observed in R0 resection, however with R1 
resection a modest benefit to a 6-month course of oral capecitabine chemotherapy was observed 
in the BILCAP trial for patients with iCCA and dCCA [Primrose et al, 2019; Shroff et al, 2019]. 
The NCCN Hepatobiliary Cancer guidelines (Version 5.2021) recommend adjuvant 
capecitabine, alternative fluoropyrimidine-based, gemcitabine-based, or chemoradiation for R1 
resected tumors, but leave the choice of therapy or observation to the treating physician’s 
discretion for R0 resected tumors. 
4.1.5.1. 
Cholangiocarcinoma KRAS Mutations 
The frequency of KRAS mutations has been reported higher at 36% to 40% of extrahepatic CCA 
compared with 8% to 24% in iCCA in US-based series [Ettrich et al, 2019; Churi et al, 2014]. 
Likewise, in an Italian series, the KRAS mutation frequency was higher at 47.4% of extrahepatic 
CCA versus 15.7% in iCCA [Simbolo et al, 2014]. A limited number of manuscripts have 
reported the spectrum of KRAS mutations (Table 9), where G12D is the most common observed 
allele in iCCA but G12C is more common in extrahepatic CCA [Zou et al, 2014; Churi et al, 
2014]. 
Table 9: 
KRAS Mutation Spectrum in Cholangiocarcinoma 
 
G12D 
% 
G12V 
% 
G12R 
% 
G13D 
% 
G12C 
% 
G12A 
% 
G12S 
% 
Reference: 
Cholangiocarcinoma 
(iCCA) 
41 
35 
nr 
nr 
12 
12 
nr 
Zou et al, 2014 
Cholangiocarcinoma 
(iCCA) 
50 
17 
8 
nr 
nr 
17 
8 
Churi et al, 2014 
Cholangiocarcinoma 
(extrahepatic) 
13 
13 
nr 
25 
38 
13 
nr 
Churi et al, 2014 
Cholangiocarcinoma 
(not specified) 
nr 
20 
60 
20 
nr 
nr 
nr 
Ettrich et al, 2019 
iCCA=intrahepatic cholangiocarcinomas; nr=not reported 
 
Circulating tumor DNA (ctDNA) has been investigated for potential use in detecting actionable 
mutations such mKRAS [Ettrich et al, 2019]; however, studies of relapse prediction in an 
adjuvant setting have not yet been reported. Small studies of serum tumor biomarkers have been 
performed in this rare tumor type. For example, Kato and colleagues [Kato et al., 2016] studied 
143 patients with extrahepatic CCA, finding that those whose initial postoperative CA19-9 was 
>37 U/mL had increased recurrences within 1 year (69.4% vs 42.3%, p=0.012) and shorter 
survival (24.0 vs 42.9 months, p<0.001). Similarly, elevated postoperative CA19-9 >37 U/mL 
predicted short survival for iCCA patients [Kondo et al., 2014]. 

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4.1.6. 
Gallbladder Cancer 
Cancers of the gallbladder are nearly all adenocarcinomas, which arise from the secretory cells. 
The gallbladder is the most common primary cancer site among the biliary tracts.  
According to GLOBOCAN 2018 data, gallbladder cancer is the 22nd most incident but 17th most 
deadly cancer worldwide [Bray et al, 2018]. About 3,700 people are diagnosed with gallbladder 
cancer and 2,000 people die from the disease in the US each year. In 2018, about 219,000 people 
worldwide were estimated to have been diagnosed with gallbladder cancer. This constitutes 1.2% 
of all cancer diagnoses.  
Gallbladder cancer is disproportionately deadly because it is rarely found before it has advanced 
or metastasized. In fact, in the US, only about 1 in 5 gallbladder cancers are diagnosed in the 
early stages, and median survival for advanced stage cancer is no more than about a year [Rawla 
et al, 2019].  
The optimal treatment strategy for patients with resected cancer has not been determined. A 
phase 3 trial confirmed that gallbladder carcinoma patients treated with adjuvant mitomycin C 
and 5-FU had a higher 5-year survival rate of 26% compared with 14% in the control group 
(p=0.0367) [Takada et al, 2002]. For R0 or R1 resected gallbladder cancer patients, the NCCN 
Hepatobiliary Cancer guidelines [Version 5.2020] recommend capecitabine as the preferred 
adjuvant regimen, with a list of acceptable neoadjuvant regimens (BIL-C). Some institutions use 
fluoropyrimidine based chemoradiation for patients with R1 positive margins or regional nodes. 
In a small study of patients with gallbladder cancer, KRAS mutations were detected in 8 primary 
tumors cases, with a limited spectrum 75% G12R and 25% G12C [Kim et al, 2000]. Circulating 
tumor DNA assessment has not been widely studied in gallbladder cancer. ELI-002 will be 
evaluated in patients with successfully surgically resected gallbladder cancer who have mKRAS.  
4.2. 
Brief Summary of Nonclinical Pharmacology 
A subset of nonclinical studies evaluated ELI-002a, an investigational product consisting of 
8 components: 7 lipid-conjugated KRAS peptide-based antigens (Amph-Peptides, Table 3) and a 
lipid-conjugated immunostimulatory oligonucleotide adjuvant (Amph-CpG-7909, Figure 1). 
Nonclinical studies with ELI-002a or components of ELI-002a have been performed to support 
the clinical investigation of the multivalent product.  
ELI-002 2P is an investigational therapeutic vaccine consisting of a subset of 2 of the 7 Amph-
Peptides (G12D and G12R) and Amph-CpG-7909. Elicio plans to investigate the use of an 
Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, 
G12C, G12S, G13D) admixed with Amph-CpG-7909 (ELI-002 7P) in future clinical trials. 
Initial clinical data with ELI-002 2P, as well as the nonclinical data described in the 
Investigator’s Brochure, are expected to support continued development of the multivalent 
product. ELI-002 is proposed as post-surgical adjuvant treatments of MRD in patients with 
KRAS viral oncogene homolog mutated solid tumors. 
The objective of the nonclinical pharmacology program for ELI-002 was to demonstrate, in a 
C57BL/6 mouse model, the improved potency of the amphiphile-conjugated subunits (both 
antigens and adjuvant) in eliciting cellular immune responses to KRAS peptides. The C57BL/6 
model was selected because there is no readily available immunocompetent animal model of 

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cancer related to KRAS mutations and because the primary objective of these studies was to 
justify the components of the vaccine by demonstrating differential immunogenic responses 
between amphiphile-conjugated and nonconjugated vaccines. The CpG-1826 adjuvant was used 
in place of the clinical ELI-002 CpG-7909 adjuvant in most mouse pharmacology studies 
because it is more potent to agonize mouse Toll-like-receptor 9 (TLR-9). The nonclinical 
pharmacology program for ELI-002 is outlined in Table 10. 

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Table 10: 
Nonclinical Pharmacology studies of mKRAS Vaccine in Support of ELI-002 (Model = Female C57BL/6 Mice, 5, 
10 or 15/group) 
Study Title 
Groups and Test Article  
Test Article Manufacturing Site/Batch # 
Doses/Dose Volume 
ROA/Treatment 
Regimen  
KRAS Imgen #4 
7 groups:  
sKRAS-WT + CPG 
sKRAS G12D + Amph-CpG; 
sKRAS G13D + Amph-CpG; 
Amph-KRAS G12D + Amph-CpG;  
Amph-KRAS G13D + Amph-CpG; 
KRAS G12D + pIC; 
No Treatment (PBS) 
KRAS peptide (Amphiphilic or soluble): 20 µg1; 
CpG-1826 (Amphiphilic or soluble) at 5 nmol and 
pIC at 50 µg. 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 14 
KRAS Imgen #7 
12 groups:  
sKRAS-WT + CPG 
sKRAS G12D + CpG-1826; 
sKRAS G12A + CpG-1826; 
sKRAS G12R + CpG-1826; 
sKRAS G12V + CpG-1826 
sKRAS G12R + pIC; 
sKRAS G12V + pIC;  
Amph-KRAS G12D + Amph-CpG-1826;  
Amph-KRAS G12A + Amph-CpG-1826;  
Amph-KRAS G12R + Amph-CpG-1826; 
Amph-KRAS G12V + Amph-CpG-1826; 
No Treatment (PBS) 
KRAS peptide (Amphiphilic or soluble): 20 µg1; 
CpG-1826 (Amphiphilic or soluble) at 5 nmol and 
pIC at 50 µg. 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 14 

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Study Title 
Groups and Test Article  
Test Article Manufacturing Site/Batch # 
Doses/Dose Volume 
ROA/Treatment 
Regimen  
KRAS Imgen #8 
6 groups:  
sKRAS WT + CpG-1826 
sKRAS G12D + CpG-1826 
sKRAS G12R/V + CpG-1826 
Amph-KRAS G12D + Amph-CpG-1826 
Amph-KRAS G12R/V + Amph-CpG-1826 
No Treatment (PBS) 
KRAS peptide (Amphiphilic or soluble): 20 µg1; 
CpG-1826 (Amphiphilic or soluble) at 5 nmol. 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 14, Day 23 
KRAS Imgen #9 
7 groups:  
sKRAS WT + CpG-1826 (bw) 
sKRAS WT + CpG-1826 (w) 
sKRAS G12D + CpG-1826 (bw); 
sKRAS G12D + CpG-1826 (w); 
Amph-KRAS G12D + Amph-CpG-1826 (bw); 
Amph-KRAS G12D + Amph-CpG-1826 (w); 
No Treatment (PBS) 
KRAS peptide (Amphiphilic or soluble): 50 µg1; 
CpG-1826 (Amphiphilic or soluble) at 5 nmol. 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 (w and 
bw) 
Boost: Day 7 (w) 
Boost: Day 14 (w and 
bw) 
KRAS Imgen 
#12 
7 groups: 
sKRAS G12D + sol CpG-1826  
sKRAS G12D + Amph-CpG-1826 
sKRAS G12D + pIC  
Amph-KRAS G12D + Amph-CpG-1826 
sKRAS WT + sCpG-1826 
Amph-CpG-1826 (No antigen) 
No Treatment (PBS) 
KRAS peptide (Amphiphilic): 18.75 µg1 (50 µg based 
on total construct mass); KRAS peptide (soluble): 50 
µg1; CpG-1826 (Amphiphilic or soluble) at 5 nmol; 
pIC 50 μg. 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 14, Day 27, 
Day 41, Day 55, and 
Day 66 

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Study Title 
Groups and Test Article  
Test Article Manufacturing Site/Batch # 
Doses/Dose Volume 
ROA/Treatment 
Regimen  
KRAS Imgen 
#14 
7 groups: 
sKRAS G12D + sol CpG-1826 
sKRAS G12D + Amph-CpG-1826 
sKRAS G12D + pIC 
Amph-KRAS G12D + Amph-CpG-1826 
sKRAS WT + sol CpG-1826 
Amph-CpG-1826 
PBS (No treatment control group) 
KRAS peptide (Amphiphilic): 7.5 µg1 (20 µg based 
on total construction mass); KRAS peptide (soluble): 
20 µg1; CpG-1826 (Amphiphilic or soluble) at 5 nmol 
and pIC at 50 µg. 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 14, Day 28, 
Day 42 
KRAS Imgen 
#14.2 
5 groups: 
Vehicle (5% EtOH, 3.3 mM HCl) 
Adjuvant (Amph-CpG-7909) alone 
Amph-KRAS mutant pool (7 peptides) + 0.6 nmol 
Amph-CpG-7909  
Amph-KRAS mutant pool (7 peptides) + 3 nmol 
Amph-CpG-7909  
Amph-KRAS mutant pool (7 peptides) + 15 nmol 
Amph-CpG-7909  
KRAS peptide pool: 30 μg/dose of Amph-KRAS 
G12D; 3 μg/dose of all others: Amph-KRAS G12A, 
Amph-KRAS G12C, Amph-KRAS G12S, Amph-
KRAS G12R, Amph-KRAS G12V, Amph-KRAS 
G13D for a total of 48μg of Amph-Peptide per dose 
Amph-CpG-7909 alone at 15 nmol (125 μg/100 μL) 
Amph-CpG-7909 in combination with Amph-KRAS 
peptide pool at 0.6, 3 and 15 nmol (5, 25 and 
125 μg/100 μL) 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Days 10, 17, 24, 
and 39  
KRAS Imgen 
#15 
9 groups: 
Untreated 
Amph-KRAS G12D + 0.1nmol Amph-CpG-1826 
Amph-KRAS G12D + 1nmol Amph-CpG-1826 
Amph-KRAS G12D + 5nmol Amph-CpG-1826  
Amph-KRAS G12D + 5nmol sCpG-1826  
sKRAS G12D + 0.1nmol Amph-CpG-1826 
sKRAS G12D + 1nmol Amph-CpG-1826 
sKRAS G12D + 5nmol Amph-CpG-1826  
sKRAS G12D + 5nmol sCpG-1826  
KRAS peptides (Amphiphilic): 7.5 µg1 (20 µg based 
on total construct mass); KRAS peptides (soluble): 
20 µg1; Amph-CpG-1826 was dosed at 0.1, 1 and 
5 nmol and soluble CpG-1826 was dosed at 5 nmol 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 14, Day 28, 
Day 74 

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Study Title 
Groups and Test Article  
Test Article Manufacturing Site/Batch # 
Doses/Dose Volume 
ROA/Treatment 
Regimen  
KRAS Imgen 
#26 
PBS (vehicle) 
Amph-KRAS G12D (fresh preparation) + 5 nmol 
Amph-CpG-1826 
Amph-KRAS G12D (aged preparation) + 5 nmol 
Amph-CpG-1826 
Amphiphilic KRAS peptides (fresh or aged) were 
dosed at 30 µg based on total construct mass; Amph-
CpG-1826 was dosed at 5 nmol 
Dose volume: 100 µL administered divided as a SC 
injection on either side of the tail head (50 µL per 
injection site) 
ROA: SC 
Prime: Day 0 
Boost: Day 13, Day 27 
BLAST P 
Report 
In silico BLAST search for Amph-Peptide sequences 
N/A 
N/A 
KRAS= Kirsten rat sarcoma; mKRAS = mutant Kirsten rat sarcoma; PBS = phosphate-buffered saline, pIC = polyinosinic:polycytidylic acid; ROA = route of 
administration; SC = subcutaneous; w = weekly; bw = biweekly; Amph-G#X = Amph-KRAS G#X, eg, Amph-G12D = Amph-KRAS G12D 
1Based on peptide mass alone 
 

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These nonclinical pharmacology studies demonstrate that despite the historically poor 
immunologic responses of mice to mKRAS peptides, they consistently mounted potent immune 
responses to the amphiphile conjugated vaccine that were superior to control soluble vaccines 
lacking the amphiphile modification.  
• The weight of evidence of in vivo data indicates that immunization with amph-
mKRAS peptides and amph-CpG1826 or soluble mKRAS and Amph-CpG-1826 
stimulated a stronger memory immune response, as indicated by cytokine release, to 
the corresponding short and long peptides than did immunization with soluble 
mKRAS and soluble CpG-1826 or soluble mKRAS + pIC. (KRAS Imgen #7; KRAS 
Imgen #12, KRAS Imgen #8, KRAS Imgen #9). 
• The immunologic response was characterized by a strong Th1 response and cytolytic 
function against KRAS-specific targets, both in vitro and in vivo. Very low amounts 
of Th2 cytokines like IL4 and IL10 were generated in vitro (KRAS Imgen #12, 
KRAS Imgen #14).  
• The most robust responses were generated when both peptide and adjuvant were 
amph-conjugated (KRAS Imgen #4). 
• Restimulation with short peptides elicited a weaker response than restimulation with 
long peptides (KRAS Imgen #14, KRAS Imgen #7, KRAS Imgen #8). 
• Restimulation with long wide type (WT) peptide did elicit responses in cells from 
animals vaccinated with mutant peptide but responses were lower than those induced 
by the corresponding mutant peptide (Imgen #4, Imgen #14). During toxicity 
evaluation WT Ras tissues were unaffected, suggesting that low level responses to 
WT peptide may not present a safety concern.  
• Increasing the frequency of dosing did not affect the immune response towards long 
peptide stimulation. However, it did seem to improve responses to short-peptide 
stimulation (KRAS Imgen #9).  
• Amphiphilic CpG-7909 (Amph-CpG-7909) dose-dependently increased the immune 
response to KRAS antigen. No significant immune response was detected at the 
lowest concentration of CpG; however, medium and high concentrations generated 
robust immune responses (KRAS Imgen #14.2). 
• The minimum adjuvant (aCpG) dose needed to achieve a robust immune response 
was 5 nmol (KRAS Imgen #15, KRAS Imgen #14.2). 
• The minimum effective dose (MED) identified for immunogenicity of ELI-002 in 
mice, based on available data, was 48 µg total peptide (30 µg 12D and 3 µg/peptide 
of the other 6 peptides; 5 nmol or 25 µg aCpG7909) (KRAS Imgen #14.2). 
• There was no effect of the vehicle formulation change on immunogenicity (KRAS 
Imgen #14.2). 
• There was no effect of the formation of the Amph-TM-G12D thiomorpholinone 
isomer on immunogenicity of Amph-G12D (KRAS Imgen #26). 

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• Despite the lower dosage of Amph-KRAS peptide used when based on peptide mass 
alone, the T-cell responses in mice treated with the Amph-KRAS peptide vaccines 
surpassed the responses of mice treated with soluble equivalents (KRAS Imgen #12, 
KRAS Imgen #14, KRAS Imgen #15). 
• BLAST searches using either the wild type or mutant sequence demonstrated identity 
with sequences in over 300 human proteins, and particularly those that are other 
products of human RAS genes [BLAST Results Summary], however there has been 
no evidence of autoimmune phenomena described in other KRAS vaccine trials using 
the same peptide sequences. There was no non-RAS potential cross-reactivity 
identified by BLAST-P alignment. 
Since antitumor activity of mKRAS specific T cells can lead to durable clinical response [Tran et 
al, 2016, Chatani and Yang, 2020], the ELI-002 in vivo pharmacology observations 
demonstrating increased antigenicity and potent CD4 and CD8 T cell responses suggest potential 
for antitumor activity and clinical benefit.  
4.3. 
Brief Summary of Pharmacokinetics and Toxicokinetics 
Pharmacokinetics/toxicokinetics (PK/TK) are not assessed for vaccinations since systemic 
exposure is not observed. Therefore, PK/TK will not be assessed in the nonclinical development 
program for ELI-002. 
4.4. 
Brief Summary of Toxicology  
ELI-002a is an investigational version of ELI-002 used in nonclinical toxicology testing. ELI-
002a consists of all 7 Amph modified KRAS peptides (Amph-Peptides, Table 3) and the lipid-
conjugated immunostimulatory oligonucleotide adjuvant (Amph-CpG-7909, Figure 1). 
Nonclinical studies with ELI-002a or components of ELI-002a have been performed to support 
the clinical investigation of the multivalent product.  
ELI-002 2P is an investigational therapeutic vaccine consisting of a subset of 2 of the 7 Amph-
Peptides (G12D and G12R) and Amph-CpG-7909. Elicio plans to investigate the use of an 
Amph-Peptide 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, 
G12C, G12S, G13D) admixed with Amph-CpG-7909 (ELI-002 7P) in future clinical trials. 
Initial clinical data with ELI-002 2P, as well as the nonclinical data described in the 
Investigator’s Brochure, are expected to support continued development of a multivalent 
product. ELI-002 is proposed as post-surgical adjuvant treatment of MRD in patients with 
KRAS/NRAS viral oncogene homolog mutated solid tumors including CRC and PDAC. 
4.4.1. 
Repeat-Dose Toxicity Studies 
4.4.1.1. 
Study No. 2795-001: Amph-CpG-7909 (with and without Amph-Peptide-G12D): 
A 4-Week Subcutaneous Injection Tolerability Study in Male C57BL/6 Mice 
Subcutaneous administration of the adjuvant (Amph-CpG-7909) with and without peptide 
(Amph-G12D) to male C57BL/6 mice once weekly for 4 weeks was well tolerated. Moderate to 
severe erythema noted at 200/80 µg adjuvant/peptide (0.2 mL total dose volume) was deemed to 
be adverse.  

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Based on the available data, Amph-CpG-7909 alone was tolerable up to 100 µg (0.2 or 0.4 mL 
total dose volume) and Amph-CpG-7909 + Amph-Peptide was tolerable at 100/80 µg 
adjuvant/peptide (0.2 or 0.4 mL total dose volume) as well as 200/80 µg adjuvant/peptide at a 
higher dose volume (0.4 mL total dose volume). Based on these data, the high dose of adjuvant 
was set at 125 µg in a total injection volume of 300 µL. 
4.4.1.2. 
Study 2795-002: A GLP 3-Month Study of ELI-002 by Subcutaneous Injection in 
C57BL/6 Mice with a 5-Week Recovery Period 
Two control groups (a phosphate-buffered saline control and an adjuvant only control) were 
included. Groups of mice (15-20/sex/group) were dosed on Days 1, 8, 15, 22, 29, 36 and 64 and 
euthanized on Days 8, 43, 71, and 99. Three dose levels were employed, with the same dose of 
Amph-Peptide (48 µg of the aggregate of 7 peptides) at each dose level; only the adjuvant dose 
varied. 
The administration of 48 µg Amph-Peptides with either 5 µg or 25 µg Adjuvant was well 
tolerated with a dose-dependent reduced (relative to the high dose) incidence and severity of 
local irritation and limited associated effects. However, high dose adjuvant (125 µg Adjuvant 
alone and 48 µg Amph-Peptides/125 µg Adjuvant) was not well tolerated, with 3 of 90 animals 
in each group (with and without peptide) animals euthanized in extremis as a result of increased 
severity of clinical observations around the injection site. There were also positive dermal scores; 
clinical pathology and organ weight including increased lymph node size, effects indicative of an 
immune/inflammatory response; and histopathology consisting of injection site ulceration, 
inflammation and osseous proliferation, as well as the spread of extensive abdominal/peritoneal 
and regional inflammation. These effects were all considered subsequent to exacerbated local 
toxicity at the injection site and were considered adverse. Therefore, the no-observed-adverse-
effect level (NOAEL) was 48 µg Amph-Peptides/25 µg Adjuvant.  
The mouse toxicology data indicate that the adjuvant, rather than the peptide, was primarily 
responsible for the observed toxicity in these studies. During toxicity evaluation WT RAS tissues 
were unaffected, suggesting that low level responses to WT peptide may not present a safety 
concern. The dose multiples from the highest dose of adjuvant that was well tolerated in mice 
(25 µg) to the proposed adjuvant doses in humans of 0.1, 0.5, and 2.5 mg are 599x, 120x, and 
24x, respectively (based on body surface area). As a large molecule expected to undergo 
intracellular rather than hepatic or renal clearance, a fixed dose of ELI-002 will be administered 
in this study. 
4.5. 
Safety Pharmacology 
Safety pharmacology studies were not conducted since soluble mKRAS peptides identical in 
amino acid sequence to those in ELI-002 have been well tolerated when previously evaluated in 
clinical studies in cancer subjects [Gjertsen et al, 2001; Wedén et al, 2011; Abou-Alfa et al, 
2011; Rahma et al, 2014; Toubaji et al, 2008; Palmer et al, 2020] and Amph-mKRAS peptides 
are not expected to have any effects on core physiological systems that are different from those 
of soluble mKRAS peptides. 
Similarly, soluble CpG-7909 has been previously evaluated and found to be well tolerated in 
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with an MTD observed in one oncology study of myalgia and constitutional effects [Zent et al, 
2012] and Amph-CpG-7909 is not expected to have any effects on core physiologic systems that 
are different from those of soluble CpG-7909.  
4.6. 
ELI-002: An Investigational Treatment for KRAS/NRAS Mutated 
Solid Tumors 
4.6.1. 
Mechanism of Action  
Therapeutic vaccines for cancer commonly seek to stimulate the expansion of cytotoxic T cells 
specific to antigens from malignant cells. Following activation, these antigen-specific cells 
infiltrate tumor sites, recognize tumor cells expressing antigen through major histocompatibility 
complex (MHC) presentation, and execute cytotoxic effector functions to kill target cells. 
ELI-002 employs this general paradigm to target mKRAS and mNRAS-driven malignancies 
expressing mutant forms of KRAS/NRAS. The sequence of amino acids is identical between 
KRAS and NRAS surrounding positions 12 and 13, and the National Cancer Institute has 
demonstrated that RAS-specific T cells cross recognize both mKRAS and NRAS tumors 
[Chatani and Yang, 2020]. Upon SC injection, the components of the vaccine are drained from 
the peripheral tissues into the lymph nodes. KRAS/NRAS Amph-Peptides are then taken up by 
antigen-presenting immune cells for processing through the proteasomal pathway. Peptide 
fragments produced through proteasomal degradation are loaded onto MHC molecules and 
presented on the cell surface for recognition by T lymphocytes through T-cell receptor 
interactions. In parallel, Amph-CpG-7909 is taken up by lymph node resident immune cells for 
endocytic processing. Immune cells expressing TLR-9 are activated by CpG, a process which 
leads to expression and secretion of pro-inflammatory factors supportive of adaptive immunity 
including T lymphocyte activation. Within this pro-inflammatory context, T-cells capable of 
specific recognition of antigen engage with APCs and are clonally expanded, activated, and 
licensed for killing of antigen-bearing target cells [Yang et al, 2016a; Yang et al, 2016b; Yang et 
al, 2017]. 
4.6.2. 
Amphiphile Lymph Node Delivery Background  
Subunit vaccines are an attractive strategy for eliciting therapeutic immunity given the ease, 
speed, and low cost of manufacturing for small molecules and biopolymers such as peptides and 
oligonucleotides [Liu et al, 2014]. However, subunit vaccines consisting of linear peptides and 
molecular adjuvants often elicit only minimal immunological responses in animals and humans. 
Previous studies have demonstrated that poor lymphatic drainage, and thus inefficient delivery to 
immune cells, is a significant factor leading to the observed lack of potency for these vaccination 
strategies.  
Empirical studies have established 2 competing mechanisms for solute drainage from peripheral 
tissues: (1) passage through the endothelial basement membranes into systemic blood circulation 
and (2) drainage from the tissue into lymphatic vessels and circulation through the lymph 
system. The predominant pathway taken for any individual molecule following SC injection is 
determined by molecular size. Specifically, solutes <3 nm in size easily pass through the 
endothelial basement membranes and are rapidly cleared from the tissues into the blood before 
elimination in the kidneys and liver. Importantly, molecules of this size are not delivered to 

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draining lymph nodes. Conversely, for solutes >3 nm in size, passage into blood vessels is 
inefficient, and molecules >5 nm in size are excluded completely via physiological barriers from 
clearance into the blood. Rather molecules of this size are drained through convective transport 
through the tissues into lymphatic vessels and perfuse the lymph nodes prior to re-entry into the 
blood via the thoracic duct through the subclavian vein. Thus, the minimal potency observed for 
subunit vaccines can be attributed, in substantial part, to their lack of delivery into the lymph 
nodes based on their size of <3 nm. Consequently, improved delivery of these subunit vaccine 
components to lymph nodes holds promise for greatly enhancing overall immunological 
responses and therapeutic efficacy.  
Correlative to the established size-dependent biodistribution paradigm, clinical studies have 
demonstrated that compounds <3 nm in size which bind avidly to albumin after injection are 
effectively concentrated in draining lymph nodes rather than being cleared through the systemic 
circulation. Further, these albumin-binding compounds efficiently accumulate in 
antigen-presenting immune cells once delivered into the draining lymph nodes. The basis for this 
paradoxical observation is the innate biodistribution pattern of endogenous albumin. Albumin, a 
66.5 kDa protein, is present at high concentrations throughout the body, and is exclusively 
drained from the peripheral tissues into the lymphatics due to its high molecular weight (MW). 
Therefore, compounds which otherwise would be cleared into the blood due to their small 
molecular size take on the biodistribution properties of albumin by binding to the larger 
molecule.  
Vaccine responses have been boosted by the use of altered peptide ligands that enhance T-cell 
responses against tumor antigens. Moynihan et al found that vaccines that were modified with 
albumin-binding domains helped to transport these molecules throughout the lymphatic system 
and increased T-cell response [Moynihan et al, 2018]. Liu et al reported this lymph-node 
targeting as “albumin hitchhiking.” In mice, structurally optimized CpG-DNA/peptide-amph-
vaccines increased lymph node accumulation and resulted in a 30-fold increase in T-cell priming 
and enhanced anti-tumor efficacy with reduced systemic toxicity [Liu et al, 2014]. 
Building on these observations, the amphiphile approach seeks to improve vaccine potency by 
targeting conventional vaccine components for specific delivery to the lymph nodes through 
simple chemical modifications which impart affinity for albumin. Specifically, peptide antigens 
or molecular adjuvants are chemically conjugated to fatty-acid moieties which take advantage of 
the natural function of albumin as a fatty-acid transporter. Antigens and adjuvants modified in 
this way reversibly and persistently associate with albumin at the injection site and are carried by 
albumin into lymph nodes where they efficiently engage immune cells to promote the expansion 
of antigen-specific immunity. 
4.6.3. 
Known and Potential Risks and Benefits 
Elicio will evaluate safety and tolerability of ELI-002 as adjuvant therapy for subjects with 
KRAS/NRAS mutated PDAC and other solid tumors who have MRD to determine whether the 
potential for clinical benefit is sufficient to warrant further testing while minimizing risk. 
ELI-002 is an investigational therapy and this is the first trial to evaluate ELI-002 in humans, 
therefore, not all aspects pertaining to potential risks and benefits from it are completely known 
at this time. However, there is an extensive body of preclinical studies as well as human studies 

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conducted by other institutions on soluble versions of the peptide and CpG components used in 
ELI-002 which are reassuring.  
In addition, there are considerable data available on the risks and benefits from cancer vaccines 
as a class of therapy. The technologies for cancer vaccination have been extensively reviewed by 
Kudrin [Kudrin, 2012]. In brief, therapeutic cancer vaccines can be available off-the-shelf 
(recombinant antigen cocktails, recombinant microorganisms, whole tumor cell derived 
(allogeneic), oncolytic viruses, anti-idiotypic antibodies, DNA and gene-therapy based products) 
which could be manufactured and distributed worldwide and personalized cancer vaccines 
(autologous cells and antigens, adoptive cell transfer) which are heavily dependent on 
specialized centers of expertise and manufacturing. With extensive prior efforts and trials, one 
cancer vaccine: Dendreon’s PROVENGE® (sipuleucel-T), a dendritic cell for metastatic 
castration-resistant prostate cancer, was approved by the Food and Drug Administration (FDA) 
in 2010 which has established the clinical application of cancer vaccines.  
These cancer vaccines were generally well tolerated and most infusion-related side effects lasted 
1 or 2 days. These are the potential risks which have been associated with PROVENGE cancer 
vaccine: acute infusion reaction, chills, fever, and fatigue back pain, joint ache, fatigue, nausea, 
headache and fever [PROVENGE® USPI].  
As reported by Wedén et al, no signs of toxicity were reported and no serious adverse events 
(SAEs) attributable to the vaccine treatment were observed in any of the subjects following 
soluble mKRAS peptide vaccination, including long-term survivors who received up to 
30 injections each [Wedén et al, 2011]. 
Likewise, 5 subjects with advanced pancreatic cancer were treated with synthetic RAS peptides 
used as a cancer vaccine. All subjects were vaccinated at Day 0, and booster vaccinations were 
performed similarly on Days 7-10 and at 1 month. Further booster vaccinations were performed 
at 4-6–week intervals or as long as the subject’s immunological response and overall 
performance status permitted over a period of 2 to10 months. The treatment was well tolerated 
and could be repeated multiple times in the same subject. No sign of toxicity and no adverse 
events (AEs) were observed [Gjertsen et al, 1996].  
ELI-002 is expected to elicit common side effects often associated with vaccines such as local 
skin reaction, fever, fatigue, pain, among others which generally subside within a day or two. 
Reactogenicity refers to a subset of reactions that occur soon after vaccination and are a physical 
manifestation of the inflammatory response to vaccination. In clinical trials, information on 
expected signs and symptoms after vaccination is actively sought (or ‘solicited’). These 
symptoms may include pain, redness, swelling or induration for injected vaccines, and systemic 
symptoms, such as fever, myalgia, headache, or rash. The broader term “safety” profile refers to 
all AEs that could potentially be caused/triggered or worsened at any time after vaccination, and 
includes AEs, such as anaphylactic reactions, diseases diagnosed after vaccination and 
autoimmune events. 
The administration of 48 µg Peptide with either 5 or 25 µg Adjuvant was well tolerated in the 
rodent Study No. 2795-002 with a dose-dependent reduced incidence and severity of local 
irritation and limited associated effects. Therefore, the NOAEL was 48 µg Amph-Peptides/25 µg 
Adjuvant. Local reactions were considered adverse at the high adjuvant Amph-CpG-7909 dose 
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reactions and some flu-like symptoms are expected in subjects who receive peptide injections, 
and there is always a possibility of hypersensitivity reactions. Injection site reaction is the only 
AE known to be attributed to ELI-002. Reactogenicity monitoring will occur throughout the 
ELI-002-001 trial (see Section 12.2.1.3)  
Since ELI-002 has increased potency compared to prior soluble vaccines in T-cell production 
and because dose-dependent increases in cytokines were observed, there will be a 7-day 
enrollment stagger between treatment of the first subject in a given cohort and the treatment of 
subsequent subjects and laboratory cytokine monitoring will be included for all subjects. 
It is expected that ELI-002 based upon its demonstrated mechanism of action, will likely evoke 
immunological response leading to clinical benefit among protocol subjects.  
4.6.4. 
Trial Rationale 
KRAS is mutated in one quarter of human solid tumors, including the vast majority of pancreatic 
cancers, and substantial portions of colorectal, non-small cell lung, ovarian, gallbladder and bile 
duct cancers. KRAS is a validated oncogene that when mutated drives tumor growth and 
maintenance. Enhancing the T-cell immune response to tumors by utilizing the targeted KRAS 
ELI-002 product candidate has the potential to improve the outcomes of subjects who have 
undergone resection surgery and/or who have MRD following locoregional therapy, a clinical 
setting with the highest ratio of ELI-002 induced T cells to target tumor cells. For example, the 
pancreatic population selected for this trial is comprised of subjects who have already received 
chemotherapy/ chemoradiation (in the neoadjuvant and/or adjuvant setting) as well as 
pancreatectomy with an R0 (no residual tumor cells observed) or R1 (microscopic residual tumor 
cells observed) outcome, yet who have poor prognosis with persistent ctDNA post-surgery 
indicating an expected median relapse-free survival (RFS) of only 5 months [Groot et al, 2019]. 
The selection of cancer patients with MRD for evaluation of a cancer immunotherapy product 
candidate has several potential advantages: 
• Maximization of the effector T-cell:target tumor cell ratio by minimization of tumor 
burden by successful prior therapy 
• Maximization of T-cell trafficking potential because the fibrous stromal present in 
advanced tumors that can exclude T-cells has not yet formed 
• Clinical settings where cytotoxic chemotherapy is not utilized, preserving the full 
potential of induced T-cells to persist and traffic 
The Phase 1 study is an open-label, single-arm, dose-escalation trial incorporating a 3+3 design 
in subjects with KRAS/NRAS mutated PDAC and other solid tumors who have MRD. 
Approximately18 subjects are planned to be enrolled in Phase 1 to evaluate the safety, 
tolerability, and exploratory pharmacodynamic efficacy of SC ELI-002 using the adjuvant at 
3 planned dose levels (Amph-CpG-7909 0.1 mg SC, 0.5 mg SC, 2.5 mg SC) in combination with 
a fixed dose of Amph-Peptides (700 μg each). Additional cohorts may be added to explore 
intermediate or higher dose levels. This will be based on the cumulative safety review and 
preliminary review of efficacy. If additional cohorts are added, this will be documented in a 
study memo sent to all clinical sites and submitted to IRBs, per IRB guidance. 

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During the study, ELI-002 will be comprised of 1.4 mg of 2 Amph modified KRAS peptides, 
Amph-G12D, and Amph-G12R (0.7 mg/peptide) admixed with Amph-CpG-7909 to provide 
ELI-002 2P. Elicio plans to investigate the use of an Amph-Peptide 7P drug product containing 
all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) admixed with Amph-
CpG-7909 (ELI-002 7P) in future clinical trials. 
Since ELI-002 has increased potency compared to prior soluble vaccines in T-cell production 
and because dose-dependent increases in cytokines were observed, there will be a 1-week stagger 
between enrollment of the first subject in a cohort and the subsequent subjects and laboratory 
cytokine monitoring will be included for all subjects. In addition, all patients will be asked to 
stay within 1 hour of the clinic following the first dose of ELI-002. In the absence of toxicity 
during the dose-limiting toxicity (DLT) assessment window, ELI-002 will be escalated. Planned 
cohort dose levels are listed below: 
• Cohort 1 Dose Level 1: Amph-CpG-7909 0.1 mg with Amph-Peptides 
• Cohort 2 Dose Level 2: Amph-CpG-7909 0.5 mg with Amph-Peptides 
• Cohort 3 Dose Level 3: Amph-CpG-7909 2.5 mg with Amph-Peptides 
Cohorts will consist of 3 to 6 subjects (the number will depend on whether DLTs are observed). 
In order to ensure an adequate number of evaluable subjects, up to 6 subjects may be enrolled per 
cohort even in the absence of a DLT. 
Dose escalation from one cohort to the next will be determined by the Safety Monitoring 
Committee (SMC), and will be based on treatment-emergent AEs, clinical laboratory data, 
physical examination (PE) findings including vital signs, after all subjects within a cohort have 
completed 28 days.  
In any cohort, if none of the subjects experience a DLT during the first 28 days following first 
administration of ELI-002, the dose escalation will occur, and 3 subjects will be enrolled in the 
cohort at the next dose level. However, if 1 of the 3 or 4 initial subjects in a cohort experiences a 
DLT, then 3 (or 2, if 4 were originally enrolled) additional subjects will be enrolled at the same 
dose level. If 2 or more of 3 subjects within a cohort experience a DLT, then this dose will be 
considered the toxic dose. If only 1 of 6 subjects within a cohort experiences a DLT during the 
first 28 days of treatment, then the next cohort may begin enrollment. If 2 or more of 6 subjects 
within a cohort experience a DLT during the first 28 days, then this dose will be considered the 
toxic dose. The trial may proceed at a lower dose, at a less frequent schedule, or omitting the 
Amph-CpG-7909 adjuvant while continuing to administer the peptides, based on emerging 
toxicity or pharmacodynamic data until the maximum tolerated dose (MTD) is determined. 
A trial memo will be sent to all sites following each SMC meeting summarizing the decisions; if 
additional cohorts are to be enrolled, the dose level and schedule will be provided. 
The recommended Phase 2 dose (RP2D) will be defined in consideration of the MTD (if any), 
safety data, and pharmacodynamic data. The RP2D will be communicated to all sites in a trial 
memo following the last SMC cohort review. Once the RP2D is determined, the cohort 
evaluating the Phase 2 dose will be expanded as needed so that there is safety experience with at 
least 6 subjects at this dose level.  

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Subject replacement: If a subject discontinues for any reason other than toxicity prior to 
completing 28 days of ELI-002 therapy, a replacement subject will be added to the cohort until 
3 subjects per cohort complete 28 days of ELI-002 therapy.  
4.6.5. 
Rationale for Endpoints 
The safety and tolerability endpoints to define the MTD (in the event there is an MTD), to define 
the RP2D, and to characterize the incidence of AEs and clinically significant changes laboratory 
tests are standard endpoints that are used in many trials of immune-therapy agents including with 
CAR T cells that exhibit similar mechanism of action to ELI-002. For example, CD19 CAR T 
cells were initially evaluated with the standard 3+3 design [Lee et al, 2015] as were BCMA CAR 
T cells [Raje, 2019]. Important immune related adverse events (IRAEs) may occur late with 
immune-oncology products. For example, the median time to onset of IRAEs when the 
checkpoint inhibitor nivolumab was administered in 576 subjects with advanced metastatic 
melanoma was 5.0 weeks for skin toxicities and 15.0 weeks for renal toxicities [Weber et al, 
2017]. Therefore, the safety evaluation committee will take into account not only the MTD 
evaluation but rather the totality of all safety observations obtained to that point in the conduct of 
the trial including any serious toxicities occurring beyond the DLT evaluation window when 
making dose escalation decisions and when considering the definition of the RP2D. 
Median RFS and median OS are exploratory endpoints that will provide preliminary data that 
may show a trend for a dose response in an outcome measure suitable to support the design of 
pivotal trials in the adjuvant setting. For example, DFS has been used as the primary endpoint 
supporting the approval of adjuvant breast cancer hormonal therapy, adjuvant chemotherapy for 
CRC, and adjuvant chemotherapy for breast cancer [Guidance for Industry, Clinical Trial 
Endpoints, 2018], and OS may be suitable in populations where there is a short interval between 
progression and death.  
Exploratory objectives are intended to confirm the preliminary efficacy of ELI-002, and to 
provide evidence of a dose response in pharmacodynamic activities that may show when the 
optimal biologic dose has been achieved. Minimal residual disease response can provide a 
preliminary proof of concept for efficacy if ELI-002 results in reduction/clearance of ctDNA 
and/or serum tumor biomarkers. Emerging data using the ctDNA assay have shown a high 
median lead time for ctDNA changes relative to radiographic relapse and very high positive 
predictive value for in colorectal and NSCLC [Abbosh et al, 2017; Reinert et al, 2019] resulting 
in an FDA Breakthrough Device Designations in 2019 and 2021. Efficacy biomarkers CA-125, 
CEA, and CA19-9 will also be characterized where appropriate. In addition, exploratory 
objectives are included to document that ELI-002 induces the intended immune responses. T cell 
responses in PBMCs will be assessed by immune assays such as IFN Fluorospot, intracellular 
cytokine staining (ICS), and/or dextramers. Patient reported outcomes (PROs) will be 
characterized to explore the potential symptomatic benefit of immunotherapy in protocol 
population. The PROs used are European Organization for Research and Treatment of Cancer 
(EORTC) Quality of Life Questionnaire (QLQ)-C30 for general health, and for specific tumor 
types, QLQ-PAN26 for pancreatic, QLQ-CR29 for colorectal, QLQ-OV28 for ovarian 
carcinoma, QLQ-BIL21 for biliary cancer, or QLQ-LC13 for NSCLC. 

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4.6.6. 
Rationale for Dose Selection 
The clinical starting dose is based on prior clinical experience with both KRAS peptides and 
CpG-7909 and is supported by nonclinical data. In prior vaccine trials with mKRAS peptides, 
doses of peptides ranging from 100 to 5000 µg have been used, both as single peptides and in 
combination. Therefore the 700 μg per Amph-Peptide, 1400 μg total Amph-Peptide dose in this 
study is within the range previously evaluated in other clinical trials. Although other adjuvants 
were used in the previously conducted KRAS vaccine clinical trials, soluble CpG-7909 has been 
administered SC in other trials in cancer subjects at total doses up to at least 40 mg and on a 
body weight basis as high as 0.48 mg/kg [Melisi et al, 2014]. The dose-ranging Study No. 2795-
001 (Section 4.4.1.1) also strongly supports the starting dose being proposed in this trial.  
The administration of 48 µg Amph-Peptide with either 5 or 25 µg Adjuvant was well tolerated in 
the rodent Study No. 2795-002 (Section 4.4.1.2) with a dose-dependent reduced incidence and 
severity of local irritation and limited associated effects. Therefore, the NOAEL was 48 µg 
Amph-Peptide/25 µg Adjuvant. 
The 3 planned dose levels for this trial are Amph-CpG-7909 0.1 mg SC, 0.5 mg SC, and 2.5 mg 
SC in combination with a fixed dose of 2 Amph-Peptides (700 μg each).  

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5. 
TRIAL OBJECTIVES  
5.1. 
Primary Objectives 
The primary objectives of Phase 1 are: 
• To assess the safety and tolerability of ELI-002 as adjuvant therapy for subjects with 
KRAS mutated PDAC and other solid tumors who have MRD identified using either 
ctDNA or a serum tumor biomarker 
• To define the MTD (in the event there is an MTD) and the RP2D 
5.2. 
Secondary Objective 
The secondary objective of Phase 1 is: 
• To assess ctDNA reduction and clearance, defined as the reduction or clearance of 
ctDNA compared to baseline, or if ctDNA was not detectable at baseline, serum 
tumor biomarker (such as CA19-9, CEA, and CA-125) reduction and clearance 
compared to baseline. 
5.3. 
Exploratory Objectives 
The exploratory objectives of Phase 1 are: 
• To report the median RFS and median OS 
• To assess the change relative to baseline in: 
− Serum cytokines interleukin (IL)-2, IFNγ, IL-6, IL-10, and tumor necrosis factor 
alpha (TNFα) 
− PROs: EORTC QLQ-C30 and QLQ-PAN26, QLQ-CR29, QLQ-OV28, 
QLQ-BIL21, or QLQ-LC13 
− To evaluate the immunogenicity of ELI-002. T cell responses to ELI-002 will be 
assessed using assays such as ICS, Fluorospot, and/or dextramer+ T cells for 
subjects with HLA alleles for which dextramer/s is/are available 
− Biomarker levels (ctDNA, CA19-9, CEA, and CA-125)  
− To evaluate tumor-infiltrating T cells and the tumor microenvironment after 
dosing with ELI-002 
• To correlate biomarker data to clinical safety and efficacy (RFS, OS)  

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6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Trial Design 
ELI-002-001 is an open-label, Phase 1 trial of ELI-002 immunotherapy as adjuvant treatment for 
subjects with KRAS/NRAS mutated PDAC and other solid tumors who are at high risk for 
relapse (ie, presence of isolated tumor cells as detected by ctDNA or elevated serum tumor 
biomarkers in the subject’s body, in which the primary tumor has been removed and is currently 
without clinical signs of disease). High relapse risk is defined by either a ctDNA-positive result 
or an elevated serum tumor biomarker (such as CA19-9, CEA, or CA-125).  
This Phase 1 study comprises an open label, single arm, dose-escalation trial incorporating a 3+3 
design in subjects with mKRAS/mNRAS solid tumors (PDAC, CRC, NSCLC, ovarian, CCA, 
and gallbladder carcinoma). 
Approximately 18 subjects are planned to be enrolled in the study to evaluate the safety, 
tolerability and exploratory pharmacodynamic efficacy of SC ELI-002 using the adjuvant at 3 
planned dose levels (Amph-CpG-7909 0.1 mg SC, 0.5 mg SC, 2.5 mg SC) in combination with a 
fixed dose of Amph-Peptides (700 μg each). Additional cohorts may be added to explore 
intermediate or higher dose levels. This will be based on the cumulative safety review and 
preliminary review of efficacy. If additional cohorts are added, this will be documented in a 
study memo sent to all clinical sites and submitted to IRBs, per IRB guidance. 
During the study, ELI-002 will be comprised of 1.4 mg of 2 Amph modified KRAS peptides, 
Amph-G12D, and Amph-G12R (0.7 mg/peptide) admixed with Amph-CpG-7909 to provide 
ELI-002 2P. Elicio plans to investigate the use of an Amph-Peptide 7P drug product containing 
all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) admixed with Amph-
CpG-7909 (ELI-002 7P) in future clinical trials.  
The ELI-002-001 protocol is an open label, single arm, dose-escalation trial incorporating a 3+3 
design. Subjects will receive the initial dose of ELI-002 and be monitored for 24 hours in order 
to monitor for potential AEs such as cytokine release syndrome (CRS). In addition, there will 
also be a 1-week stagger between enrollment of the first subject in a cohort and the subsequent 
subjects. In the absence of toxicity during the DLT assessment window, the ELI-002 dose will be 
escalated. Planned cohort dose levels are listed below: 
• Cohort 1 Dose Level 1: Amph-CpG-7909 0.1 mg with Amph-Peptides 
• Cohort 2 Dose Level 2: Amph-CpG-7909 0.5 mg with Amph-Peptides 
• Cohort 3 Dose Level 3: Amph-CpG-7909 2.5 mg with Amph-Peptides 
Phase 1 cohorts will consist of 3 to 6 subjects (the number will depend on whether DLTs are 
observed). In order to ensure an adequate number of evaluable subjects, up to 6 subjects may be 
enrolled per cohort even in the absence of a DLT. Once the RP2D is determined, the cohort 
evaluating the RP2D will be expanded as needed so that there is safety experience with at least 
6 subjects at this dose level. 
Dose escalation from one cohort to the next will be determined by the SMC, and will be based 
on treatment-emergent AEs, clinical laboratory data, PE findings including vital signs, after all 
subjects within a cohort have completed 28 days. At each SMC meeting, longer follow-up will 

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be available on all but the final subject in each cohort. The SMC will review all available long-
term safety information from prior cohorts (if any), so that the SMC will consider the totality of 
the safety information in their recommendation. 
The trial will consist of:  
• A Screening Period in which study specific procedures, including eligibility 
determination, will begin at Visit 1, following surgical resection. 
• An Immunization Period which will consist of 6 SC injections: 4 weekly injections 
(Visit 3 to Visit 6) followed by 2 injections every two weeks at Visit 7 and Visit 8.  
• A No Dosing 3-Month Period in which subjects will continue to be observed and 
evaluated.  
• A Booster Period, consisting of 4 weekly injections (Visit 12 to Visit 15), in which 
eligible subjects will receive further lymph node antigen exposure. 
• A Follow-up Period which will provide continued safety and efficacy data. 
All subjects will be observed for safety and tolerability. Computed tomography (CT) with 
contrast or magnetic resonance (MRI) imaging will occur at screening and at additional 
timepoints indicated in the Schedule of Assessments, Table 13 and Table 15, until confirmed 
radiographic relapse is observed.  
The central laboratory will confirm that at least 1 of the 2 mKRAS/NRAS alleles targeted by 
ELI-002 2P (G12D and G12R) is present and either ctDNA is positive or there are successive 
rising values of serum biomarker (such as CA19-9, CEA, or CA-125) from samples taken at 
≥21 days post-surgery or after the last administration of adjuvant treatment (whichever comes 
last in the specific subject treatment plan). These data are required for determination of eligibility 
and inclusion into the trial. 
Immunologic biomarkers of response may include HLA typing, serum cytokines, ICS, 
Fluorospot, and/or dextramer+ T cells for subjects with appropriate HLA alleles will be 
determined when matching dextramer/s is/are available. 
Local laboratories will be utilized for serum cytokine testing, tumor biomarkers 
CA19-9/CEA/CA-125, tumor biopsy assays (such as biomarker sequencing and/or IHC assays) 
and all other safety laboratory tests.  
Central laboratories will be utilized for ctDNA analysis, HLA typing, PBMC isolation and 
immunogenicity assessment, such as Fluorospot, ICS, and/or T cell dextramer testing as detailed 
in the central laboratory manual. 
While HLA testing will be performed prior to first dose at Visit 3, cohorts will be enrolled 
regardless of the subject HLA subtype.  
Discontinuation of trial treatment: Subjects with confirmed radiographic relapse (using 
iRECIST criteria; not judged as pseudoprogression) during treatment with ELI-002 will 
discontinue trial treatment but should continue other trial-related procedures in the follow-up 
period. The ORR using iRECIST criteria will be characterized for any cross-over subjects. 
The design of the trial is outlined in Figure 2 and Figure 3. 

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Figure 2: 
ELI-002 Trial Cohort Schematic 
 
All cohorts will enroll PDAC, CRC, NSCLC and OST (including ovarian, bile duct and gallbladder carcinoma. 
 
Figure 3: 
Protocol ELI-002-001: Phase 1 Trial Design 
 
ctDNA=circulating tumor deoxyribonucleic acid; KRAS=Kirsten rat sarcoma; RFS=relapse-free survival; 
SC=subcutaneous 

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6.1.1. 
Safety Monitoring  
This is an open label, single arm, dose-escalation trial incorporating a 3+3 design. 
Approximately 18 subjects are planned to be enrolled to evaluate the safety, tolerability and 
exploratory pharmacodynamic efficacy of ELI-002 at 3 planned dose levels (0.1 mg SC, 0.5 mg 
SC, 2.5 mg SC) in combination with a fixed dose of Amph-Peptides (700 μg each). Additional 
cohorts may be added to explore intermediate or higher dose levels. This will be based on the 
cumulative safety review and preliminary review of efficacy. If additional cohorts are added, this 
will be documented in a study memo sent to all clinical sites and submitted to IRBs, per IRB 
guidance. 
During the study, ELI-002 will be comprised of 1.4 mg of 2 Amph modified KRAS peptides, 
Amph-G12D, and Amph-G12R (0.7 mg/peptide) admixed with Amph-CpG-7909 to provide 
ELI-002 2P. Elicio plans to investigate the use of an Amph-Peptide 7P drug product containing 
all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) admixed with Amph-
CpG-7909 (ELI-002 7P) in future clinical trials.  
Subjects will receive the initial dose of ELI-002 and be monitored for 24 hours in order to 
monitor for potential AEs such as CRS. In addition, there will be a 1-week stagger between 
enrollment of the first subject in a cohort and the subsequent subjects. In the absence of toxicity 
during the dose-limiting toxicity (DLT) assessment window, ELI-002 will be escalated. 
Cohorts will consist of 3 to 6 subjects (the number will depend on whether DLTs are observed). 
In order to ensure an adequate number of evaluable subjects, up to 6 subjects may be enrolled per 
cohort even in the absence of a DLT. 
Dose escalation from one cohort to the next will be determined by the SMC, and will be based 
on treatment-emergent AEs, clinical laboratory data, PE findings including vital signs, after all 
subjects within a cohort have completed 28 days.  
In any cohort, if none of the subjects experience a DLT during the first 28 days following first 
administration of ELI-002, the dose escalation will occur, and 3 subjects will be enrolled in the 
cohort at the next dose level. However, if 1 of the 3 or 4 initial subjects in a cohort experiences a 
DLT, then 3 (or 2, if 4 were originally enrolled) additional subjects will be enrolled at the same 
dose level. If 2 or more of 3 subjects within a cohort experience a DLT, then this dose will be 
considered the toxic dose. If only 1 of 6 subjects within a cohort experiences a DLT during the 
first 28 days of treatment, then the next cohort may begin enrollment. If 2 or more of 6 subjects 
within a cohort experience a DLT during the first 28 days, then this dose will be considered the 
toxic dose. The trial may proceed at a lower dose, at a less frequent schedule, or omitting the 
Amph-CpG-7909 adjuvant while continuing to administer the Amph-Peptides, based on 
emerging toxicity or pharmacodynamic data until the MTD is determined. 
A trial memo will be sent to all sites following each SMC meeting summarizing the decision; if 
additional cohorts are to be enrolled, the dose level and schedule will be provided. 
Safety monitoring is further detailed in the SMC Charter.  
The RP2D will be defined in consideration of the MTD (if any), safety data, and 
pharmacodynamic data. The RP2D will be communicated to all sites in a trial memo following the 
last SMC cohort review. Once the RP2D is determined, the cohort evaluating the Phase 2 dose will 
be expanded as needed so that there is safety experience with at least 6 subjects at this dose level. 

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Please refer to Section 6.7 for management of study drug-related events. DLT Guidelines are 
specifically detailed in Section 6.7.3. 
6.1.2. 
Criteria for Booster and Additional Booster Vaccines  
Accumulating clinical evidence indicates some subjects treated with an immunotherapy, such as 
ELI-002, may be assessed as having disease progression by conventional response criteria before 
demonstrating clinical objective responses and/or stable disease [Wolchok et al, 2009]. This 
pseudoprogression has been observed in the ELI-002-001 trial. Two hypotheses have been 
suggested to explain this phenomenon. The first is that enhanced inflammation within the lesions 
could lead to an increase in the lesion size which would appear as enlarged index lesions and 
therefore as newly visible small non-index lesions. Over time, both the malignant and 
inflammatory portions of the lesion(s) may then decrease leading to overt signs of clinical 
improvement. The second hypothesis is that, in some subjects, the speed of the lesion growth 
may initially outpace the anti-tumor immune activity of the therapy. With sufficient time, the 
anti-tumor activity will dominate and become clinically apparent. Therefore, subjects 
participating on ELI-002-001 will be allowed to continue ELI-002 treatment, as specified in this 
protocol, after initial investigator assessed progression (iUPD via iRECIST) if the subject is 
deriving clinical benefit and tolerating the study treatment well in the judgement of the 
investigator.  Subjects must discontinue treatment upon confirmed disease progression.  
All subjects free of confirmed radiographic progression will receive booster doses unless they 
have unresolved toxicity. For subjects which have encountered signs of toxicity, the investigator 
must consult with the sponsor’s medical monitor who must agree with resuming the subsequent 
booster vaccinations (see Section 6.7.1).  
Subjects who remain in the trial until the end of the required Follow-up Period may be eligible to 
enroll in a separate extension protocol to continue to receive further lymph node antigen 
exposure to maintain effective levels of antigen-specific T-cells.  
6.1.3. 
Screening for Human Leukocyte Antigen Subtypes  
High-resolution HLA information can be helpful in analyzing immune responses. Therefore, 
high-resolution (ie, DNA based) HLA typing will be collected via blood sample for all subjects 
at pre-dose Visit 3 using the central laboratory. Cohorts will be enrolled regardless of the 
subject’s HLA type.  
6.1.4. 
Schedule of Assessments 
The schedules of assessments are provided in Table 11 through Table 16. 

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Table 11: 
Schedule of Assessments- Screening and Observation 
Assessment 
Screening and Observation 
Period 
Visit 
Surgery/Last Dose of 
Adjuvant Treatment 
Visit 1 
Visit 2 
Day (± days) 
0 
Day 10 (Days 1-31) 
Day 26 (±5 days) 
Written informed consent  
X
1 
 
Tumor tissue and EDTA blood sample for whole exome 
sequencing (central laboratory)2 
X
2 
 
Pregnancy testing (urine) 
 
X 
Patient reported outcomes 
 
X3 
Demographics (including sex, age, race and ethnicity) 
 
X 
Height/weight 
 
X 
Record medical and medication history, including cancer 
history/prior treatments and current medications. 
 
X 
Review of eligibility criteria 
 
X
4 
Physical examination 
 
X
5 
Vital signs 
 
X 
ECG 
 
X 
ECOG 
 
X
6 
CT with contrast 
 
X
7 
Clinical laboratory (local laboratory) 
 
X
8 
Serum CA-125, CEA, CA19-9 (local laboratory) 
 
X9 
Covid-19 viral test (local laboratory) 
 
X
10 
ctDNA (central laboratory)11 
 
X11 
Leukapheresis-PBMC collection for immunogenicity testing 
(central laboratory) 
 
X12 
Adverse events 
 
X 

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CA=carbohydrate antigen; CBC=complete blood count; CEA=carcinoembryonic antigen; CRC=colorectal cancer; CT=computed tomography; 
ctDNA=circulating tumor deoxyribonucleic acid; DNA=deoxyribonucleic acid; ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology 
Group; EDTA=ethylenediaminetetraacetic acid; IV=intravenous; mKRAS=mutant Kirsten rat sarcoma; mNRAS=mutant neuroblastoma; 
MRI=magnetic resonance imaging; PDAC=pancreatic ductal adenocarcinoma; PBMC=peripheral blood mononuclear cell  
1. The ICF has no expiration and can be signed at any time during or after the prior treatment (including surgery/resection). The screening window (56 days) 
begins when the first screening procedure is performed. 
2. Depending on the clinical site location, a tumor and blood sample will be collected for KRAS mutation status. The tumor sample, if required, will be used for 
WES to determine KRAS mutation and to develop the tumor-informed personalized ctDNA test. Details are provided in the Central Laboratory Manual. Once a 
subject has consented, the trial coordinator will requisition a retrospective tumor tissue sample taken during surgical resection (if needed per clinical site location). 
Prior to shipment, a fresh 6-mL EDTA blood tube will also be collected. Tumor DNA will be sequenced for baseline tumor gene expression. The somatic DNA 
from the EDTA tube will serve as a control to ensure only tumor-specific DNA is included in the selection for ctDNA testing.  
3. The patient reported outcomes (PROs) will include the general QLQ-C30, as well as a specific PRO for the subject’s tumor type (see Section 11.3). PROs 
must be completed prior to other study visit procedures. 
4. See Inclusion and Exclusion Criteria in Section 7.1 and Section 7.2, respectively. While mKRAS and ctDNA analyses will not be available at Visit 2, the 
expectation is that these will be reviewed, and full eligibility determined, prior to Visit 3. 
5. 
Physical examinations are defined in Section 12.1.3. 
6. 
To be eligible, ECOG performance status must be 0 to 1 (see Section 12.1.5) 
7. 
To be eligible, post-operative CT must be negative for radiographic recurrent disease. CT imaging assessments will occur within 90 days of first ELI-002 dose, 
following resection or last dose of adjuvant treatment (whichever comes last in the specific subject treatment plan). For subjects with IV contrast 
allergy/intolerance, MRI may be performed. 
8. 
See Inclusion Criterion #9 regarding laboratory values in Section 7.1. Safety laboratories should include CBC with differential: chemistry to include parameters 
listed in Section 12.1.6.3; hematology to include parameters listed in Section 12.1.6.1; coagulation to include parameters listed in Section 12.1.6.2; cytokine 
laboratories IL-2, IFNγ, IL-6, IL-10, and TNFα; viral testing to include parameters listed in Section 12.1.6.5. Details for central laboratory sample collections are 
provided in the Central Laboratory Manual. 
9. 
See Inclusion #4 regarding serum biomarker values in Section 7.1. Biomarker values must be obtained ≥21 days post-surgery or last administration of adjuvant 
therapy, whichever comes last in the specific subject’s treatment plan. 
10. Samples such as swabs, saliva, or others as appropriate may be used for Covid-19 viral testing according to the locally available assay. 
11. Blood will be collected for ctDNA analysis at a central laboratory. Eligibility requires that subject’s must be MRD positive, as measured by either a ctDNA 
blood test persisting ≥21 days post-surgery or after last administration of adjuvant treatment (whichever is last in the specific subject treatment plan) or 
serum biomarker, with 1 of the 2 ELI-002-specific mKRAS/mNRAS alleles. Details for blood collection are provided in the Central Laboratory Manual. 
12. The leukapheresis sample must be collected once eligibility has been confirmed and prior to the first dose of ELI-002. The PBMCs may be used for 
immunogenicity and/or biomarker genetic sequencing. Details for central laboratory sample collections are provided in the Central Laboratory Manual. 
 

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Table 12: 
Schedule of Assessments- Immunization Period 
Assessment 
Immunization Period 
Visit 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Visit 8 
Day (± days) 
Day 57 
Baseline 
(prior to 
dosing) 
Day 57 
(dosing) 
(±3 days) 
Day 64 
(±3 days) 
Day 71 
(±3 days) 
Day 78 
(±3 days) 
Day 92 
(±3 days) 
Day 106 
(±3 days) 
Dose # 
- 
Dose 1 
Dose 2 
Dose 3 
Dose 4 
Dose 5 
Dose 6 
Patient reported outcomes 
X1 
 
X1 
X1 
X1 
X1 
X1 
Review medical history 
X2 
Review cancer history/prior treatments 
X 
Physical Exam 
X3 
X3 
X3 
          X3 
          X3 
          X3 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
X 
ECG 
X 
 
ECOG 
X 
X 
X 
X 
X 
X 
Concomitant medications  
X 
X 
X 
X 
X 
X 
Clinical laboratory (local laboratory) 
X4 
X4 
X4 
X4 
X4 
X4 
ctDNA (central laboratory)5 
X5 
 
 
X5 
 
 
Whole blood-PBMC collection for immunogenicity 
testing (central laboratory) 
 
 
X4 
 
X4 
 
Serum collection of cytokine assay (local laboratory) 
X4 
X4 
X4 
X4 
X4
 
X4 
High Resolution HLA typing (central laboratory) 
X6 
 
 
 
 
 
Trial drug (ELI-002) administration 
 
X7 
X7 
X7 
X7 
X7 
X7 
Adverse events 
X8 
X8 
X8 
X8 
X8 
X8 
X8 
Reactogenicity diary9 
 
X 
X 
X 
X 
X 
X 
CA=carbohydrate antigen; CBC=complete blood count; CEA=carcinoembryonic antigen; CRC=colorectal cancer; CRS=cytokine release syndrome; CT=computed 
tomography; ctDNA=circulating tumor deoxyribonucleic acid; ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group: HLA=human leukocyte antigen; 
IFNγ=interferon gamma; IL=interleukin; mKRAS=mutant Kirsten rat sarcoma; mNRAS=mutant neuroblastoma ras viral oncogene homolog; MRD=minimal residual 
disease; PBMC=peripheral blood mononuclear cell; PDAC=pancreatic ductal adenocarcinoma; PE=physical examination; TNFα=tumor necrosis factor alpha 
1. 
The patient reported outcomes (PROs) will include the general QLQ-C30, as well as a specific PRO for the subject’s tumor type (see Section 11.3). PROs must be completed 
prior to other study visit procedures. 
2. 
Subjects must have recovered from surgery without any ongoing medical/surgical issues. See Inclusion and Exclusion Criteria in Section 7.1 and Section 7.2, respectively. 
3. 
Physical examinations are defined in Section 12.1.3. In addition, a neurological examination for baseline ICANS/ICE assessment will be performed at Visit 3, prior to 

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dosing. 
4. 
Safety laboratories should include CBC with differential: chemistry to include parameters listed in Section 12.1.6.3; hematology to include parameters listed in 
Section 12.1.6.1; coagulation to include parameters listed in Section 12.1.6.2. Cytokine laboratories IL-2, IFNγ, IL-6, IL-10, and TNFα; this testing should be performed and 
reviewed within 7 days prior to dosing. The PBMCs may be used for immunogenicity and/or biomarker genetic sequencing. Details for central laboratory sample 
collections are provided in the Central Laboratory Manual. 
5. 
ctDNA blood testing will occur at a central laboratory. Details for blood collection are provided in the Central Laboratory Manual 
6. 
High resolution HLA will be performed for all subjects, prior to first dose at Visit 3. Cohorts will be enrolled regardless of the HLA subtype (see Section 6.1.3 for 
details). Details for blood collection are provided in the Central Laboratory Manual.  
7. 
ELI-002 administration: Subjects will receive the initial dose of ELI-002 and be monitored for ≥24 hours in order to monitor for potential adverse events such as CRS. For 
subsequent doses, subjects must be observed for safety for at least 1-hour postdose. 
8. 
Check for signs of toxicity. See Section 6.7 for instructions regarding signs of toxicity and for criteria for stopping treatment administration. 
9. 
Subjects will be provided with a paper reactogenicity diary at the end of the visit. They will be instructed to fill out the diary each day, for 7 days, at the same time per 
the instructions on the study template. Subjects will return the completed diary at the next scheduled visit. The site staff will review the diary with the subject and file in 
the subject study records. This completed diary will be used as source data for eCRF data entry. 
 

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Table 13: 
Schedule of Assessments- No Dosing 3-Month Period 
Assessment 
No Dosing 3-Month Period 
Visit 
Visit 9 
Visit 10 
Visit 11 
Day (± days) 
Day 120  
(±3 days) 
Day 148  
(±3 days) 
Day 176  
(±3 days) 
Patient reported outcomes 
X1 
X1 
X1 
Physical examination 
X
2 
X
2 
X
2 
Vital signs 
X 
X 
X 
Weight 
X 
X 
X 
Changes in concomitant medications 
X 
X 
X 
CT with contrast 
 
X3 
 
Clinical laboratory (local laboratories) 
X
4 
X
4 
X
4 
ctDNA (central laboratory)5 
 
 
X
5 
Leukapheresis-PBMC collection for immunogenicity testing (central laboratory) 
X6  
 
 
Whole blood-PBMC collection for immunogenicity testing (central laboratory) 
 
 
X
7 
Serum collection for cytokine (local laboratory) 
 
 
X
4 
Serum CA-125/CEA/CA 19-9 (local laboratories) 
 
X
4 
 
Standard of care biopsy (local laboratory) 
 
X8 
 
Adverse events 
X 
X 
X 
CA=carbohydrate antigen; CBC=complete blood count; CEA=carcinoembryonic antigen; CRC=colorectal cancer; CRP=C-reactive protein; CT=computed 
tomography; ctDNA=circulating tumor deoxyribonucleic acid; IFNγ=interferon gamma; IL=interleukin; IV=intravenous; mKRAS=mutant Kirsten rat sarcoma; 
mNRAS=mutant neuroblastoma ras viral oncogene homolog; MRI=magnetic resonance imaging; PBMC=peripheral blood mononuclear cell TNFα =tumor 
necrosis factor alpha 
1. 
The patient reported outcomes (PROs) will include the general QLQ-C30, as well as a specific PRO for the subject’s tumor type (see Section 11.3). PROs must 
be completed prior to other study visit procedures. 
2. 
Physical examinations are defined in Section 12.1.3. 
3. 
A visit window of ±14 days is permitted for imaging assessments. For subjects with IV contrast allergy/intolerance, MRI may be performed. Unscheduled CT or 
MRI imaging may be performed at any time, if the investigator determines that there are clinical signs of disease progression.    
4. 
Safety laboratories should include CBC with differential: chemistry to include parameters listed in Section 12.1.6.3; hematology to include parameters listed in 
Section 12.1.6.1; coagulation to include parameters listed in Section 12.1.6.2. Cytokine laboratories IL-2, IFNγ, IL-6, IL-10, and TNFα. Serum biomarkers 
CA-125 [ovarian], CA19-9 [PDAC] or CEA [CRC]. Details for central laboratory sample collections are provided in the Central Laboratory Manual 
5. 
ctDNA blood testing will occur at a central laboratory. Details for blood collection are provided in the Central Laboratory Manual 
6. 
The leukapheresis sample may be collected -7 days or +3 days from Visit 9. The PBMCs may be used for immunogenicity and/or biomarker genetic sequencing. 
Details for central laboratory sample collections are provided in the Central Laboratory Manual. 

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7. 
The PBMCs may be used for immunogenicity and/or biomarker genetic sequencing. Details for central laboratory sample collections are provided in the 
Central Laboratory Manual. 
8. 
If new lesions are observed on radiographic imaging, a standard of care biopsy may be performed per iRECIST criteria to confirm disease progression and when the 
investigator judges that tissue can be safely obtained.  If there is sufficient tissue obtained from the biopsy, the pathology lab should perform in situ gene expression 
and/or IHC for evaluation of tumor infiltrating T cells and the tumor microenvironment. 

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Table 14: 
Schedule of Assessments- Booster Period 
Assessment 
Booster Period 
Visit 
Visit 12 
Visit 13 
Visit 14 
Visit 15/ 
End of Treatment 
Day (± days) 
Day 196  
(±3 days) 
Day 203  
(±3 days) 
Day 210  
(±3 days) 
Day 217  
(±3 days) 
Dose # 
Dose 7 
Dose 8 
Dose 9 
Dose 10 
Patient reported outcomes 
X1 
X1 
X1 
X1 
Physical examination 
X2 
X2 
X2 
X2 
Vital signs 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
ECOG 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
Clinical laboratory (local laboratory) 
X3 
X3 
X3 
X3 
ctDNA (central laboratory)4 
X4 
 
 
 
Whole blood-PBMC collection for 
immunogenicity testing (central laboratory) 
 
 
X5 
 
Serum collection for cytokine assay (local 
laboratory) 
X3 
X3 
X3 
X3 
Trial drug (ELI-002) administration 
X6 
X6 
X6 
X6 
Adverse events 
X7 
X7 
X7 
X7 
Reactogenicity diary8 
X 
X 
X 
X 
CA=carbohydrate antigen; CBC=complete blood count; CEA=carcinoembryonic antigen; CRC=colorectal cancer; ctDNA=circulating tumor 
deoxyribonucleic acid; ECOG=Eastern Cooperative Oncology Group; IFNγ=interferon gamma; IL=interleukin; IV=intravenous; mKRAS=mutant 
Kirsten rat sarcoma; mNRAS=mutant neuroblastoma ras viral oncogene homolog; MRI=magnetic resonance imaging; PBMC=peripheral blood 
mononuclear cell; PDAC=pancreatic ductal adenocarcinoma; TNFα =tumor necrosis factor alpha 
1. The patient reported outcomes (PROs) will include the general QLQ-C30, as well as a specific PRO for the subject’s tumor type (see Section 11.3). PROs must 
be completed prior to other study visit procedures. 
2. Physical examinations are defined in Section 12.1.3. 
3. Safety laboratories should include CBC with differential: chemistry to include parameters listed in Section 12.1.6.3; hematology to include parameters listed in 
Section 12.1.6.1; coagulation to include parameters listed in Section 12.1.6.2. Cytokine laboratories TNFα =tumor necrosis factor alpha IL-2, IFNγ, IL-6, IL-10, 
and TNFα; this testing should be performed and reviewed within 7 days prior to dosing. Details for central laboratory sample collections are provided in the Central 
Laboratory Manual 
4. ctDNA blood testing will occur at a central laboratory. Details for blood collection are provided in the Central Laboratory Manual 
5. The PBMCs may be used for immunogenicity and/or biomarker genetic sequencing. Details for central laboratory sample collections are provided in the 
Central Laboratory Manual 

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6. ELI-002 administration for those subjects in Phase 1. Subjects must be observed for safety for at least 1-hour postdose. 
7. Check for signs of toxicity. See Section 6.7 for instructions regarding signs of toxicity and for criteria for stopping treatment administration. 
8. Subjects will be provided with a paper reactogenicity diary at the end of the visit. They will be instructed to fill out the diary each day, for 7 days, at the 
same time per the instructions on the study template. Subjects will return the completed diary at the next scheduled visit. The site staff will review the diary 
with the subject and file in the subject study records. This completed diary will be used as source data for eCRF data entry. 
 

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Table 15: 
Schedule of Assessments- Follow-up Period (Year 1 to Year 2) 
Assessment 
Follow-up Period 
Visit 
Visit 16 
Visit 17 
Visit 18 
Visit 19 
Visit 20 
Visit 21 
Visit 22 
Visit 23 
Visit 24 
Day (± days) 
Day 231 
(±3 days) 
Day 259 
(±3 days) 
Day 315 
(±3 days) 
Day 399 
(±3 days) 
Day 483 
(±3 days) 
Day 567 
(±3 days) 
Day 651 
(±3 days) 
Day 735 
(±3 days) 
Day 819 
(±3 days) 
Patient reported outcomes 
X
1 
X
1 
X
1 
X
1 
X
1 
X
1 
X
1 
X
1 
X
1 
Physical Exam 
 
 
 
 
X
2 
 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECOG 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CT with contrast 
 
X3 
 
X3 
X3 
X3 
X3 
X3 
X3 
Clinical laboratory (local laboratory) 
X
4 
 
 
 
 
 
 
 
 
ctDNA (central laboratory)5 
X
5 
X
5 
X
5 
X
5 
X
5 
X
5 
X
5 
X
5 
X
5 
Whole blood-PBMC collection for 
immunogenicity testing (central laboratory) 
X
6 
 
 
 
 
 
X6 
 
 
Serum CA-125/CEA/CA 19-9 (local 
laboratory) 
 
X
4 
 
X
4 
X
4 
X
4 
X
4 
X
4 
X
4 
Serum collection for cytokine analysis (local 
laboratory) 
X
4 
 
 
 
 
 
 
 
 
Adverse events 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
Standard of care biopsy (local laboratory) 
 
X8 
 
X8 
X8 
X8 
X8 
X8 
X8 
CA=carbohydrate antigen; CBC=complete blood count; CEA=carcinoembryonic antigen; CRC=colorectal cancer; ctDNA=circulating tumor 
deoxyribonucleic acid; ECOG=Eastern Cooperative Oncology Group; IFNγ=interferon gamma; IL=interleukin; IV=intravenous; mKRAS=mutant 
Kirsten rat sarcoma; mNRAS=mutant neuroblastoma ras viral oncogene homolog; MRI=magnetic resonance imaging; PBMC=peripheral blood 
mononuclear cell; PDAC=pancreatic ductal adenocarcinoma; TNFα =tumor necrosis factor alpha 
1. 
The patient reported outcomes (PROs) will include the general QLQ-C30, as well as specific PROs for the subject’s tumor type (see Section 11.3). PROs 
must be completed prior to other study visit procedures. 
2. 
Physical examinations are defined in Section 12.1.3. 
3. 
A visit window of ±14 days is permitted for imaging assessments during the Follow-up Period. For subjects with IV contrast allergy/intolerance, MRI may be 
performed. Unscheduled CT or MRI imaging may be performed at any time, if the investigator determines that there are clinical signs of disease progression. 
4. 
Safety laboratories should include CBC with differential: chemistry to include parameters listed in Section 12.1.6.3; hematology to include parameters listed in 
Section 12.1.6.1; coagulation to include parameters listed in Section 12.1.6.2. Cytokine laboratories IL-2, IFNγ, IL-6, IL-10, and TNFα. Serum biomarkers CA-
125 [ovarian], CA19-9 [PDAC] or CEA [CRC]. Details for central laboratory sample collections are provided in the Central Laboratory Manual 
5. 
ctDNA blood testing will occur at a central laboratory. Details for blood collection are provided in the Central Laboratory Manual 

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6. 
The PBMCs may be used for immunogenicity and/or biomarker genetic sequencing. Details for central laboratory sample collections are provided in the Central 
Laboratory Manual. 
7. 
Long-term observation for post dose vaccination adverse events will be recorded if an adverse event began within 30 days of last dose of treatment and 
continues in the follow-up period. See Section 6.7 for instructions regarding signs of toxicity. 
8. 
If new lesions are observed on radiographic imaging, a standard of care biopsy may be performed per iRECIST criteria to confirm disease progression and when the 
investigator judges that tissue can be safely obtained.  If there is sufficient tissue obtained from the biopsy, the pathology lab should perform in situ gene expression 
and/or IHC for evaluation of tumor infiltrating T cells and the tumor microenvironment. 
9. 
All enrolled subjects should be followed in the Follow-Up period for disease status and overall survival.  As part of the study, sites may conduct searches of public 
records, such as those establishing overall survival status, to obtain survival data as needed (ie: a subject that is lost to follow-up, withdraws from the study, etc.) 
 

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Table 16: 
Schedule of Assessments- Follow-up Period (Year 2 to Year 3) 
Assessment 
Follow-up Period 
Visit 
Visit 25 
Visit 26 
Visit 27 
Visit 28/  
End of Study6 
Day (± days) 
Day 903 
(±3 days) 
Day 987 
(±3 days) 
Day 1071 
(±3 days) 
Day 1127 
(±3 days) 
ECOG 
X 
X 
X 
X 
CT with contrast 
X1 
X1 
X1 
X1 
ctDNA (central laboratory) 
X
3 
X
3 
X
3 
X
3 
Serum CA-125/CEA/CA 19-9 (local 
laboratory) 
X
2 
X
2 
X
2 
X
2 
Adverse events 
X4 
X4 
X4 
X4 
Standard of care biopsy (local laboratory) 
X5 
X5 
X5 
X5 
CA=carbohydrate antigen; CEA=carcinoembryonic antigen; CRC=colorectal cancer; CT=computed tomography; ctDNA=circulating tumor 
deoxyribonucleic acid; ECOG=Eastern Cooperative Oncology Group; IV=intravenous; MRI=magnetic resonance imaging; PDAC=pancreatic ductal 
adenocarcinoma;  
1. 
A visit window of ±14 days is permitted for imaging assessments during the Follow-up Period. For subjects with IV contrast allergy/intolerance, MRI may be 
performed. Unscheduled CT imaging or MRI may be performed at any time, if the investigator determines that there are clinical signs of disease progression. 
2. 
Serum biomarkers CA-125 [ovarian], CA19-9 [PDAC] or CEA [CRC]. Details for central laboratory sample collections are provided in the Central Laboratory 
Manual 
3. 
ctDNA blood testing will occur at a central laboratory. Details for blood collection are provided in the Central Laboratory Manual 
4. 
Long-term observation for post dose vaccination adverse events will be recorded if an adverse event began within 30 days of last dose of treatment and 
continues in the follow-up period. See Section 6.7 for instructions regarding signs of toxicity. 
5. 
If new lesions are observed on radiographic imaging, a standard of care biopsy may be performed per iRECIST criteria to confirm disease progression and when the 
investigator judges that tissue can be safely obtained.  If there is sufficient tissue obtained from the biopsy, the pathology lab should perform in situ gene expression 
and/or IHC for evaluation of tumor infiltrating T cells and the tumor microenvironment. 
6. 
All enrolled subjects should be followed in the Follow-Up period for disease status and overall survival.  As part of the study, sites may conduct searches of public 
records, such as those establishing overall survival status, to obtain survival data as needed (ie: a subject that is lost to follow-up, withdraws from the study, etc.) 

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6.1.5. 
Risk Determination for Investigational In Vitro Diagnostics 
Protocol ELI-002-001 incorporates two different investigational in vitro diagnostics (IVDS). 
Only one IVD will be used for each subject’s enrollment, based on ability to access acceptable 
tumor sample and/or upon Elicio’s instruction. 
1. Tissue-informed personalized ctDNA assay: This approach requires two assays, a tissue 
based Comprehensive Genomic Profiling (CGP) test based on WES (KRAS mutation) 
followed by a personalized ctDNA assay (MRD status). Both assays are performed at 
central laboratories under CLIA and CAP requirements. 
2. Plasma RAS ctDNA assay: This approach requires a single ctDNA assay to monitor both 
KRAS mutation and MRD status performed at a central laboratory under CLIA and CAP 
requirements. 
For the tumor-informed personalized ctDNA assay, to determine eligibility, subjects will have 
their tumor specimen assayed using CGP-WES to confirm presence of at least 1 of the 
mKRAS/mNRAS alleles targeted by ELI-002. Next, the WES data will be used to identify 
subject-specific somatic variants and design a personalized assay, per subject, for the detection 
of ctDNA in plasma (see Figure 4).  
For the plasma RAS ctDNA assay, to determine eligibility, subjects will proceed to have their 
blood tested to confirm the presence of at least 1 of the mKRAS/mNRAS alleles targeted by 
ELI-002 and the detection of ctDNA in plasma in a single assay (see Figure 4). 
 

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Figure 4: 
Flow Diagram of ELI-002-001 Eligibility Determination using the IVD assays  
Subjects eligible to participate must have at least 1 of the mKRAS/mNRAS alleles targeted by 
ELI-002 and they must have either detectable ctDNA or a successively rising serum tumor 
biomarker (CA19-9, CEA, or CA-125) in samples taken ≥21 days after surgery or after the last 
administration of adjuvant therapy, whichever comes last in the subject's treatment plan. The 
ctDNA status is determined by the investigation IVDs.  
Elicio considers the use of ctDNA investigational IVDs in Protocol ELI-002-001 to be 
nonsignificant risk. The planned administration of ELI-002 2P occurs after standard surgery and 
neoadjuvant and/or adjuvant chemotherapy and before relapse characterized by the re-emergence 
of clinical or radiographic symptoms. As there is no standard of care treatment for minimal 
residual disease in this space, a false positive or false negative will not result in a substitution or 
omission of standard treatment.  
6.1.5.1. 
Description of the IVDs 
6.1.5.1.1. Tumor-informed Personalized ctDNA Assay 
The tumor informed personalized ctDNA assay is composed of two parts, WES from tumor 
DNA to identify tumor-specific mutations and a plasma-based ctDNA assay to detect 
ctDNA.CGP-WES test is a CAP- and CLIA-validated Laboratory Developed Test, performed at 
a single-site laboratory. The assay compares the whole exome sequence of tumor and germline 
DNA, facilitating identification of tumor-specific DNA alterations which for the ELI-002-001 
trial will be analyzed to identify the specific subset of subjects with mKRAS/mNRAS alleles for 
Pancreatic and other solid tumors 
after completion of chemotherapy 
and surgical resection with R0 or R1 
outcome
Tumor informed personalized ctDNA 
assay uses CGP-WES on tumor 
sample to demonstrate 
mKRAS/mNRAS mutant allele 
present (G12D, G12V, G12S, G12A, 
G12C, G12R or G13D)
Tumor-infomed personalized ctDNA
assay uses WES data to design test 
to demonstrate persistence of tumor 
DNA detection ≥ 21 days post 
surgery or end of adjuvant therapy
Plasma RAS ctDNA assay 
demonstrates mKRAS/mNRAS
mutant allele present (G12D, G12V, 
G12S, G12A, G12C, G12R or G13D) 
and persistence of tumor DNA 
detection ≥ 21 days post surgery or 
end of adjuvant therapy

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eligibility. The assay is performed by target enrichments followed by 440x coverage sequencing 
on an Illumina HiSeq 2500 or NovaSeq 6000 (Illumina, Inc.). Use of CGP-WES to identify 
mKRAS alleles has been documented in pancreatic [Liang et al, 2012] and colon cancer 
[Shanmugam et al, 2014]. 
The tissue-based CGP test is intended for inclusion of subjects who are positive for any of the 
specific mutations (eg, G12Dand G12R) within the KRAS or NRAS genes that are targeted by 
the ELI-002 product candidate. In addition, the WES data will serve as the input for subject 
specific personalized Signatera ctDNA assay. 
The Natera Signatera test is a personalized multiplex-PCR and NGS-based clinical assay 
targeting 16 tumor-specific mutations. It is intended for the detection of ctDNA isolated from 
anticoagulated peripheral whole blood 
The standard Signatera assay is based on tracking driver clonal/truncal mutations that occur early 
in tumor initiation. Signatera tracks a subset of these early clonal variants to detect residual 
ctDNA with significantly increased sensitivity using a multiplexed PCR methodology. In brief, 
WES of tumor and matched normal blood are used to identify 16 clonal, somatic tumor variants 
not present in non-tumor tissues. Then a multiplexed PCR assay specific for a given subject 
assays serial plasma biospecimens – presence or absence of ctDNA is highly predictive of 
response to treatment or MRD [Sethi et al, 2018]. Signatera ctDNA positive status was 
significantly correlated with RFS across several tumor types, including mKRAS-positive colon 
[Reinert et al, 2019] and lung [Abbosh et al, 2017].  
6.1.5.1.2. Plasma RAS ctDNA Assay 
The Sysmex SafeSEQ RAS-RAF pathway assay was designed to deliver a clinical grade, ultra-
sensitive liquid biopsy solution for the identification of gene mutations in KRAS, NRAS, BRAF 
and PIK3CA. This test identifies different genomic alterations (single and multiple base 
substitutions, insertions and deletions) across 24 regions in these oncogenes. It is intended for the 
detection of ctDNA isolated from plasma. The SafeSEQ RAS-RAF pathway assay will identify 
subjects who are positive for any of the specific mutations (eg, G12D and G12R) within the 
KRAS or NRAS genes that are targeted by the ELI-002 product candidate. In addition, the 
SafeSEQ assay will inform the presence or absence of ctDNA. Unlike the tumor-informed 
personalized assay, tumor tissue is not required for KRAS mutation identification; instead, a 
single plasma sample will inform both KRAS mutation type and ctDNA positivity (MRD). 
SafeSEQ is an amplification-based NGS method which was designed for ctDNA analysis to 
suppress NGS errors and to improve the calling of low frequency mutations. This approach 
enables confidence in the calling of mutations from clinical specimens even with a low volume 
of input DNA. SafeSEQ provides nearly 100% conversion of DNA input, so that molecules, 
including rare ctDNA molecules, are effectively measured. This allows for high sensitivity and 
accuracy by discriminating sequencing artifacts from bona fide mutations. Use of SafeSEQ to 
identify KRAS and NRAS gene mutations has been documented in colorectal and pancreatic 
cancers [Bettegowda et al, 2014]. Sysmex SafeSEQ positive ctDNA detection after resection was 
associated with an increased risk of relapse in pancreatic [Lee, Lipton, et al, 2019] and colorectal 
[Tie et al, 2019] cancers.  

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6.1.5.2. 
Applying the IVD Results in the Clinical Trial 
ELI-002-001 is a Phase 1, open-label trial of ELI-002 as adjuvant therapy for subjects with 
mKRAS/mNRAS+ solid tumors who have no standard available treatment. These subjects have 
undergone surgical resection and may have positive MRD as determined by detectable ctDNA. 
MRD will be defined as the presence of ctDNA in the subject’s body, in which the primary 
tumor has been removed and the subject is currently without clinical signs of disease. The 
mKRAS/mNRAS+ status will be confirmed by CGP WES from tumor samples versus normal 
germline or from plasma RAS ctDNA from plasma samples, and ctDNA status will be 
determined by either the tumor-informed or plasma RAS ctDNA assays at screening. 
Approximately 18 subjects are planned to be treated in 3 planned dose level cohorts. The RP2D 
will be determined by consideration of the MTD (if any MTD is observed), safety data, and 
pharmacodynamic data.  
Baseline mKRAS/mNRAS status and ctDNA status for eligibility will be assessed during 
screening. 
The tumor-informed personalized ctDNA or plasma RAS ctDNA assays to detect 
mKRAS/mNRAS and MRD status will be used to assess subject eligibility for enrollment.  
The prevalence of mutations in KRAS and NRAS to be evaluated by the IVDs is reviewed in 
detail in protocol Section 4.1. The prevalence of NRAS mutations is highest in CRC among 
tumor types included in this study, while KRAS mutations are found across all histologies. 
6.2. 
Endpoints 
6.2.1. 
Primary Endpoints 
The primary endpoints of Phase 1 are: 
• To define the MTD of ELI-002 (in the event there is an MTD) and the RP2D 
• To evaluate safety as assessed by the incidence of AEs and clinically significant in 
laboratory tests and vital signs 
6.2.2. 
Secondary Endpoint 
The secondary endpoint of Phase 1 is: 
• To report the proportion of subjects with ctDNA reduction and clearance, defined as 
reduction or clearance in ctDNA compared to baseline, or if ctDNA was not 
detectable at baseline, serum tumor biomarker (such as CA19-9, CEA, and CA-125) 
reduction and clearance compared to baseline 
6.2.3. 
Exploratory Endpoints 
The exploratory endpoints of Phase 1 are: 
• Median RFS, and median OS 

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• Duration of biomarker (ctDNA or serum tumor biomarker) clearance and reduction, 
defined as time from the date of the first negative and/or decreased biomarker to the 
earliest date of any of the following events: 
− Subsequent increased/positive biomarker 
− Subsequent disease relapse 
− Death due to any cause 
• Change relative to baseline in: 
− Serum cytokines IL-2, IFNγ, IL-6, IL-10, and TNFα 
− PROs: EORTC QLQ-C30 and QLQ-PAN26, QLQ-CR29, QLQ-OV28, 
QLQ-BIL21 or QLQ-LC13 
− Immunogenicity of ELI-002 determined by magnitude of response and 
fold-change from baseline using assays such as ICS, Fluorospot, and/or 
dextramer+ T cells for subjects with HLA alleles for which dextramer/s is/are 
available 
− Biomarker levels (ctDNA, CA19-9, CEA, and CA-125)  
− Immune cell infiltrate and tumor microenvironment, if standard of care biopsies 
are obtained, to confirm disease progression 
6.3. 
Number of Subjects 
Approximately 18 subjects are planned to be enrolled in this trial: Additional cohorts may be 
added to explore intermediate or higher dose levels based on the cumulative safety review and 
preliminary review of pharmacodynamic responses. If additional cohorts are added, this will be 
documented in a study memo sent to all clinical sites and submitted to IRBs, per IRB guidance. 
6.4. 
Treatment Assignment 
Approximately 18 subjects are planned to receive SC injections of ELI-002 during the 
Immunization Period and the Booster Period. 
6.5. 
Dose Adjustment Criteria 
ELI-002 will be escalated in the planned dose increments (see Section 6.1.1). 
The SMC will have the authority to assess and recommend any dosing changes warranted due to 
safety concerns.  
There are no PK assessments in this protocol, therefore, there will be no consideration for PK 
criteria for adjustment or stopping of doses.  
6.6. 
Safety Criteria for Temporarily or Permanently Stopping the Trial 
The sponsor medical monitor will be continuously monitoring the safety of subjects. In addition, 
the cumulative safety will be reviewed by the SMC at the following key time points:  

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• After the last subject in each cohort completes the DLT observation period 
• Ad hoc as necessary 
The trial may be temporarily or permanently stopped by the sponsor, if any subject death occurs 
attributed to administration of ELI-002 (ie, if there is Grade 5 toxicity that is definitely, probably, 
or possibly attributed to trial treatment). 
Any potential re-initiation of the trial will be discussed by the Sponsor, with the support of the 
SMC and in consultation with the FDA, if necessary. 
6.7. 
Management of Study Drug-Related Events 
6.7.1. 
Temporarily Suspending Treatment Administration 
If a subject meets any of the following conditions within 48 hours prior to the scheduled 
administration of the trial treatment, treatment administration will be temporarily suspended: 
1. To reduce the risk of CRS, subjects will not be given a repeat dose of ELI-002 if they are 
exhibiting T ≥38°C and/or IL-6 ≥500 pg/mL (cytokine collection, including IL-6, may be 
performed up to 7 days prior to treatment). In addition, if a subject exhibits IFNγ 
≥1000 pg/mL, the Elicio medical monitor should be contacted for consultation. 
2. Adverse event(s) that meet the definition of DLT caused by prior treatment. See 
Section 6.7.3 for the definition of a DLT; see Section 12.4 for the definition of Common 
Terminology Criteria for Adverse Events (CTCAEs). 
3. Any subsequent dosing in a subject who has experienced Grade ≥2 CRS/ immune 
effector cell-associated neurotoxicity syndrome (ICANS) 
Investigators must consult the medical monitor to discuss any subjects meeting the above 
criteria.  
In the event the ELI-002 dose is held, the subject should not receive any make up dose and 
remain on the original protocol schedule (ie, their next dose will be at the next protocol-specified 
dose if they meet the criteria for dosing). All trial procedures and treatment administration will 
be resumed as soon as the subject’s condition allows or at the investigator’s discretion after 
Sponsor approval.  
The trial may proceed at a lower dose, at a less frequent schedule, or omitting the Amph-CpG-
7909 adjuvant while continuing to administer the Amph-Peptides, based on emerging toxicity or 
pharmacodynamic data until the MTD is determined.  
6.7.2. 
Permanent Stopping Treatment Administration  
If a subject meets any of the following conditions, the subject will be required to discontinue the 
trial treatment administration but should continue other trial-related procedures as specified for 
the follow-up period of the study. (See Section 7.3 for more information on procedures for 
subjects withdrawn from trial treatment.) 
1. Evidence of radiographic disease progression  
2. Any intolerable AE, at the investigator’s discretion 

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3. During study treatment: 
• Any investigational product use other than ELI-002 
• Other anti-cancer treatment 
4. Non-compliance with trial treatments/procedures. If a subject misses  2 trial visits 
without underlying toxicity, the subject should be re-instructed regarding dosing and 
follow-up and continue trial participation. If a subject continues to miss trial visits 
without toxicity and despite re-instruction, they should be discontinued from the trial 
treatment phase but follow-up data should be collected as possible. 
5. The subject requests to be withdrawn from the trial treatment 
For subjects whose treatment is discontinued prematurely, the procedures outlined for End of 
Treatment/Visit 15 (Table 14) will be carried out and, if possible, prior to the initiation of any 
other anti-cancer treatment. These subjects should then enter the Follow-up Period, where 
procedures listed in Table 15 and Table 16 will be performed. In the event that a subject will not 
continue to be evaluated in the Follow-up Period, the End of Study visit (Visit 24) should be 
scheduled, and all procedures performed. 
6.7.3. 
Dose-limiting Toxicity Guidelines  
A DLT will be defined as any event at least possibly related to ELI-002 as follows: 
a. Any Grade ≥ 3 non-hematologic toxicity except asymptomatic laboratory 
abnormalities (see Section 12.2.1.1) 
b. Any Grade ≥ 3 toxicity involving major organ systems for greater than 72 hours and 
occurring within 28 days of subcutaneous administration 
c. Grade 3 CRS that does not resolve to ≤ Grade 2 within 7 days 
d. Any Grade 4 CRS that does not improve to < Grade 2 within 72 hours 
e. Any Grade ≥ 3 autoimmune disorder 
f. Any Grade ≥ 3 rash that does not resolve to ≤ Grade 1 within 7 days with appropriate 
treatment 
The DLT observation period will be 28 days. 
Maximum tolerated dose definition: The MTD is defined as the highest dose level with a DLT 
incidence <33% of cohort subjects. 
See protocol Section 6.7.1 and Section 6.8 for management of toxicity. 
6.8. 
Management of Risks and Toxicities 
Review of the ELI-002 pre-clinical data indicates that certain cytokine levels such as IL-6 may 
be elevated (see Section 4.4). Elevated cytokines are a hallmark of CAR-T cell therapies often 
leading to CRS and ICANS which can be serious or fatal.  
Consequently, the management of such toxicities have been extensively reviewed through the 
CAR-T Toxicity Management Workgroup [Lee et al, 2019]. To be fully prepared in the event 
that CRS is observed, this trial will follow the same guidelines as are used for CAR-T studies as 
outlined in Section 6.8.1 through Section 6.8.2.  

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All subjects will be monitored for potential AEs such as CRS. In addition, there will be a 1-week 
stagger between enrollment of the first subject in a cohort and the subsequent subjects. In 
addition, all patients will be asked to stay within one hour travel time to the clinic for at least 
24 hours following their first ELI-002 dose. 
6.8.1. 
Management of Cytokine Release Syndrome  
Since ELI-002 activates T cells by a novel amphiphile mechanism whereby potent responses are 
generated, there is a theoretical risk for observation of T-cell-mediated toxicity.  
To reduce the risk of CRS, subjects will not be given a repeat dose of ELI-002 if they are 
exhibiting T >38°C and/or IL-6 >500 pg/mL. In addition, if a subject exhibits IFNγ 
≥1000 pg/mL, the Elicio medical monitor should be contacted for consultation. 
In the event the ELI-002 dose is held, the subject should not receive any make up dose and 
remain on the original protocol schedule (ie, their next dose will be at the next protocol-specified 
dose if they meet the criteria for dosing and with approval from the medical monitor).  
Cytokine release syndrome is caused by the release of inflammatory cytokines such as IL-6, 
IL-2, IFNγ, and TNFα, which causes a systemic inflammatory response similar to sepsis. The 
release of cytokines occurs when cells that are targeted by antibodies, immune effector cells 
(T and B-cells, Natural Killer cells, and monocytes/macrophages) are recruited to the tumor area 
and the subject’s immune cells are activated. The importance of cytokine secretion of CAR 
T cells after exposure to tumor cells is closely related to their killing activity, and the degree of 
cytokine elevation is correlated to the bulk of residual disease at the time of adoptive T-cell 
infusion, ie, tumor burden, as well as with the number of detectable CAR T-cells after 
administration [Brentjens, 2012; Lee et al, 2015, Lee et al, 2019]. IL-6 levels in patients with low 
grade 0-3 CRS were a median of 100 pg/mL, whereas IL-6 was a median of 10,000 pg/mL 
[Teachey et al, 2016] in patients with high grade 4-5 CRS. Likewise, IFNγ was approximately 
40 pg/mL in patients with low grade CRS, versus approximately 4,000 pg/mL in those with high 
grade CRS [Teachey et al, 2016] ; therefore, this protocol takes a conservative cut-point and 
mandates dose hold for ELI-002 if IL-6 >500 pg/mL is observed or contact with the medical 
monitor in the event that IFNγ > 1000 pg/mL is observed, making the assumption that although 
CRS guidelines address CAR-T safety management, ELI-002 may elicit sufficient T cells to 
merit a similar approach. The goal of CRS management is to prevent life-threatening 
complications while preserving the antitumor T cell immune response. 
Clinical signs and symptoms of CRS listed in Table 17 should raise concern.  

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Table 17: 
Clinical Symptoms of Cytokine Release Syndrome 
System 
Symptom 
Constitutional 
Fever ± rigors, malaise, fatigue, anorexia, myalgias, arthralgias 
Biochemical 
Evidence of disseminated intravascular coagulation and MAS, elevation in liver function tests, 
D-dimers, LDH, CRP, uric acid and phosphorus 
Skin 
Rash 
Gastrointestinal 
Nausea, vomiting, diarrhea 
Respiratory 
Tachypnoea, hypoxaemia 
Cardiovascular 
Tachycardia, widened pulse pressure, hypotension, arrhythmias, increased cardiac output 
(early), potentially diminished cardiac output (late) 
Coagulation 
Disseminated intravascular coagulation, elevated D-dimer, hypofibrinogenaemia ± bleeding 
Renal 
Azotaemia 
Hepatic 
Transaminitis, hyperbilirubinaemia 
Neurological 
Headache, mental status changes, confusion, delirium, word-finding difficulty or frank 
aphasia, hallucinations, tremor, dysmetria, altered gait, seizures, cerebral edema 
CRP=C-reactive protein; LDH=lactate dehydrogenase; MAS=macrophage activation syndrome 
The Common Toxicity Criteria (ie, CTCAE) grading system was originally developed to capture 
a cytokine syndrome occurring during infusion therapy; therefore, it is inadequate to capture the 
delayed CRS that occurs after repeat dose ELI-002 administration. Appreciating the scale needed 
to be adapted for other therapeutics, to define mild, moderate, severe and life-threatening events, 
account for overlapping symptoms and guide treatment recommendations, and allow cross-trial 
comparison, an objective revised consensus CRS grading system was developed by the 
American Society for Transplantation and Cellular Therapy (ASTCT) as provided in Table 18 
[Lee et al, 2019].  

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Table 18: 
Suggested Treatment by Cytokine Release Syndrome Grade 
Grade 
Treatment Requirement 
Immunosuppressive Treatment 
Grade 1 Symptoms are not life-threatening and require 
symptomatic treatment only (eg, fever, nausea, 
fatigue, headache, myalgias, malaise). Vigilant 
supportive care. Assess for infection, treat fever and 
neutropenia if present, monitor fluid balance 
Acetaminophen and other 
antipyretics/analgesic supportive measures 
Grade 2 Symptoms require and respond to moderate 
intervention: 
• 
Oxygen requirement <40%  
• 
Vigilant Supportive Care 
Acetaminophen and other antipyretic/analgesic 
supportive measures. If multiple comorbidities 
or older age are present initiate IL-6 inhibition 
with tocilizumab ± corticosteroids  
Grade 3 Symptoms require and respond to aggressive 
intervention: 
• 
Oxygen requirement ≥40% or 
• 
Hypotension requiring at least one vasopressor  
• 
Vigilant Supportive Care 
Initiate immunosuppressive therapy using 
tocilizumab and corticosteroids. 
Grade 4 Life-threatening symptoms 
• 
Requirement for ventilator support or 
• 
Grade 4 organ toxicity (excluding transaminitis) 
Initiate immunosuppressive therapy using 
tocilizumab and corticosteroids  
Grade 5 Death 
- 
High-dose vasopressor doses shown in Table 19. 
[Lee et al, 2019] 
 
When applicable, use of high-dose vasopressor is recommended as described in Table 19.  
Table 19: 
High-dose Vasopressors (All Doses are Required for ≥3 Hours) 
Therapy 
Dose 
Norepinephrine monotherapy 
≥20 µg/kg/min 
Dopamine monotherapy 
≥10 µg/kg/min 
Phenylephrine monotherapy 
≥200 µg/kg/min 
Epinephrine monotherapy 
≥10 µg/kg/min 
If on vasopressin 
Vasopressin + NE equivalent of ≥10 µg/kg/mina 
If on combination vasopressors (not vasopressin) 
Norepinephrine equivalent of ≥20 µg/kg/mina 
a VASST Trial Vasopressor Equivalent Equation: Norepinephrine equivalent dose = [norepinephrine (µg/min)] + 
[dopamine (µg/kg/min) ÷ 2] + [epinephrine (µg/min)] + [phenylephrine (µg/min) ÷ 10] 
6.8.2. 
Cytokine Release Syndrome Treatment Guidelines 
In the event CRS is observed, vigilant supportive care, including empiric treatment of concurrent 
bacterial infections and maintenance of adequate hydration and blood pressure is required for 
every grade. Blood pressure instability will be evaluated in the context of blood pressures 
obtained at baseline and at Day 1 prior to the ELI-002 vaccine. Appropriate respiratory support 
will be provided as clinically indicated. Every attempt should be made to discern and treat 
potentially overlapping symptoms arising from infections, tumor lysis syndrome, or other 

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medical complications. Blood samples for cytokine and other analysis judged to be appropriate 
by the investigator will be obtained as soon as possible and daily until clinical concern for CRS 
has resolved.  
The following clinical laboratory parameters will be followed in addition to expeditious local 
laboratory cytokine analysis:  
• C-reactive protein (CRP) 
• Complete blood count (CBC) with differential 
• Blood chemistries 
• Liver function tests 
• Ferritin 
• Coagulation parameters including prothrombin time, partial thromboplastin time, 
fibrinogen, D-dimer  
• Blood cultures 
Tocilizumab must be used as the first-line agent in the treatment of CRS. If the subject’s 
condition does not improve or stabilize within 24 hours of the tocilizumab dose, administration 
of a second dose of tocilizumab and/or a second immunosuppressive agent (such as 
corticosteroids) should be considered. 
• Tocilizumab is a recombinant humanized anti-human IL-6 receptor monoclonal 
antibody of the immunoglobulin (Ig) IgG1k subclass. It binds both the membrane 
bound and soluble forms for the IL-6 receptor, and thus blocks IL-6 mediated 
pro-inflammatory effects. Tocilizumab is approved for the treatment of CRS 
occurring in the setting of CAR-T cell therapy, rheumatoid arthritis, systemic juvenile 
idiopathic arthritis and polyarticular juvenile rheumatoid arthritis [ACTEMRA® 
USPI]. 
• Tocilizumab at a dose of 8mg/kg (max dose 800 mg; or at the level recommended by 
local standards) should be administered intravenously over 1-hour, with the option to 
repeat the dose if clinical improvement does not occur within 24 to 48 hours. There 
should be a minimum of 8 hours between consecutive doses of tocilizumab [Grupp et 
al, 2013; Lee et al, 2014; Maude et al, 2015]. 
• Corticosteroids: Corticosteroids may ablate or significantly impair T-cell function and 
may limit therapeutic benefit. However, they may be used as a secondary agent or in 
cases of severe or life-threatening CRS as front-line therapy or in conjunction with 
Tocilizumab. 
• Methylprednisolone (1mg/kg every 12 hours) is recommended, but consideration 
should be given to using Dexamethasone (10 mg/dose every 6 hours) in subjects with 
neurologic symptoms who may benefit from more efficient penetration of the blood 
brain barrier [Bonifant et al, 2016; Maude et al, 2014; Neelapu et al, 2018]. 
• Additional agents: Siltuximab (anti-IL6 mAb) [Chen et al, 2016], Etanercept (soluble 
TNFα receptor antagonist), Dasatinib (tyrosine kinase inhibitor) [Mestermann et al, 

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2019], and Anakinra (IL-1R antagonist) [Giavridis et al, 2018] are investigational but 
may be considered for use in the context of severe CRS. 
Subjects will be advised via the informed consent of the signs and symptoms of CRS. Subjects 
will be given a protocol-specific card with all necessary information for health care professionals 
to be aware that the subject is on a clinical trial and to contact the Primary Investigator (PI) 
and/or team. Subjects will be advised to seek immediate medical attention if such signs and 
symptoms occur.  
Subjects with signs and symptoms of CRS will have blood collected as soon as possible and then 
at least daily for cytokine and other analysis judged to be appropriate by the investigator until 
clinical concern for CRS has resolved. Local laboratory cytokine and other appropriate analysis 
will be undertaken as expeditiously as possible. 
6.8.3. 
ICANS Treatment Guidelines 
Neurotoxicity (eg, encephalopathy, somnolence, aphasia; ICANS) has been observed with 
previous CAR T-cell therapies and since ELI-002 potently activates T cells there is a theoretical 
risk for ICANS. 
Evaluation of any new onset ≥Grade 2 neurotoxicity should include a neurological examination, 
brain MRI, and examination of the cerebrospinal fluid (CSF) as clinically indicated. 
Endotracheal intubation may be needed for airway protection in severe ICANS cases. 
Tocilizumab and corticosteroids should be used as outlined in Table 22, and anti-epileptic may 
be considered as clinically indicated. Medications with sedative properties should be avoided, if 
possible, in the setting of neurotoxicity. ICANS should be graded in accordance with the ASTCT 
consensus definitions:  
The Immune Effector Cell-Associated Encephalopathy (ICE) scoring system is provided in 
Table 20, and the current ASTCT ICANS Consensus Grading for Adults is provided in Table 21. 
Table 20: 
Encephalopathy Assessment Tool for Grading ICANS 
 
ICE Scoring System 
Orientation 
Orientation to year, month, city, hospital: 4points 
Naming 
Ability to name 3 objects (eg, point to clock, pen, button): 3 points 
Following Commands 
Ability to follow simple commands (eg, “Show me 2 ﬁngers” or “Close your eyes and 
stick out your tongue”): 1 point 
Writing 
Ability to write a standard sentence (eg, “Our national bird is the bald eagle.”): 1 point 
Attention 
Ability to count backwards from100 by10: 1 point 
ICANS=Immune effector cell-associated neurotoxicity syndrome; ICE=Immune Effector Cell-Associated 
Encephalopathy. 
[Lee et al, 2019] 

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Table 21: 
ASTCT ICANS Consensus Grading for Adults 
Neurotoxicity 
Domain 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
ICE Scorea 
7-9 
3-6 
0-2 
0 (subject is unarousable and 
unable to perform ICE) 
Depressed level 
of 
consciousnessb 
Awakens 
spontaneously 
Awakens to 
voice 
Awakens to tactile 
stimulus 
Subject is unarousable or requires 
vigorous or repetitive tactile 
stimuli to arouse. Stupor or coma 
Seizure 
N/A 
N/A 
Any clinical seizure 
focal or generalized 
that resolves rapidly or 
nonconvulsive 
seizures on EEG that 
resolve with 
intervention 
Life-threatening prolonged seizure 
(>5 min); or repetitive clinical or 
electrical seizures without return to 
baseline in between 
Motor findingsc 
N/A 
N/A 
N/A 
Deep focal motor weakness such as 
hemiparesis or paraparesis 
Elevated 
intracranial 
pressure/ 
cerebral edema 
N/A 
N/A 
Focal/local edema on 
neuroimagingd 
Diffuse cerebral edema on 
neuroimaging; decerebrate or 
decorticate posturing; or cranial 
nerve VI palsy; or papilledema; or 
Cushing’s triad 
ASTCT=American Society for Transplantation and Cellular Therapy; CTCAE= Common Terminology Criteria for 
Adverse Events; ICANS=Immune effector cell-associated neurotoxicity syndrome; ICE=Immune Effector 
Cell-Associated Encephalopathy; N/A=not applicable 
ICANS grade is determined by the most severe event (ICE score, level of consciousness, seizure, motor ﬁndings, 
raised intracranial pressure/cerebral edema) not attributable to any other cause; for example, a subject with an ICE 
score of 3 who has a generalized seizure is classiﬁed as grade 3 ICANS.  
a: A subject with an ICE score of 0 may be classiﬁed as grade 3 ICANS if awake with global aphasia, but a subject 
with an ICE score of 0 may be classiﬁed as grade 4 ICANS if unarousable.  
b: Depressed level of consciousness should be attributable to no other cause (eg, no sedating medication).  
c: Tremors and myoclonus associated with immune effector cell therapies may be graded according to CTCAEv5.0, 
but they do not inﬂuence ICANS grading.  
d: Intracranial hemorrhage with or without associated edema is not considered a neurotoxicity feature and is 
excluded from ICANS grading. It may be graded according to CTCAEv5.0. 
[Lee et al, 2019] 

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Table 22: 
Neurotoxicity Suggested Treatment 
Neurotoxicity  
Grading assessment (CTCAE 5.0) 
Evaluation 
Treatment 
Grade 1 – Examples include:  
Somnolence-mild drowsiness or sleepiness  
Confusion-mild disorientation  
Encephalopathy-mild limiting of ADL  
Dysphasia-not impairing ability to communicate  
Neurological 
examination  
Additional work up 
as clinically indicated  
 
Vigilant supportive care  
Grade 2 – Examples include:  
Somnolence-moderate, limiting instrumental 
ADL  
Confusion-moderate disorientation, limiting 
instrumental ADL  
Encephalopathy-limiting instrumental ADL  
Dysphasia-moderate impairing ability to 
communicate spontaneously  
Consider EEG as 
clinically indicated 
Should include brain 
MRI and evaluation 
of CSF in addition to 
neurological 
examination  
Vigilant supportive care  
Consider prophylactic anti-epileptic  
 
Grade 3 – Examples include:  
Somnolence-obtundation or stupor  
Confusion-severe disorientation, limiting self-
care ADL  
Encephalopathy-limiting self- care ADL  
Dysphasia-severe receptive or expressive 
characteristics, impairing ability to read, write or 
communicate intelligibly 
Consider tocilizumab 4-8 mg/kg IV over 
1 hour (not to exceed 800 mg)  
Repeat tocilizumab if symptoms have not 
stabilized or improved within 12-24 
hours  
Consider corticosteroids (eg, 
dexamethasone 10 mg IV q6h) for 
worsening symptoms despite tocilizumab  
Consider prophylactic anti-epileptic  
Grade 4 – Examples include: 
Life-threatening consequences  
Urgent Intervention Indicated  
Mechanical Ventilation  
Corticosteroids (eg, dexamethasone 10 
mg IV q6h)  
Administer tocilizumab as per guidance 
for Grade 3 neurotoxicity if not 
previously administered  
Consider prophylactic anti-epileptic  
ADL=activities of daily life; CSF=cerebrospinal fluid; CTCAE= Common Terminology Criteria for Adverse 
Events; EEG=electroencephalogram; IV=intravenous; MRI=magnetic resonance imaging 
6.8.4. 
Management of On-target Off-tumor Toxicity  
Examples of on-target off-tumor toxicities have been observed in different immunotherapies 
where these events were not expected from pre-clinical data. It is difficult to anticipate all 
“autoimmune inflammation” that theoretically may be induced by an on-target off-tumor effect 
of ELI-002. For that reason, Grade 3 or higher autoimmune toxicity is considered a DLT (ie, fits 
non-hematologic Grade 3 toxicity; see Section 6.7.3) Any observed treatment emergent 
autoimmune events must be followed closely. The exact diagnostic and the therapeutic approach 
to be followed will be left to the investigator’s discretion who can contact at any time the 
Sponsor Medical Monitor. The Sponsor may discuss any specific case with the SMC members to 
evaluate appropriate therapeutic action. 
6.8.5. 
Management of Maculo-Papular or Acneiform Rashes, Injection Site Reactions 
For routine injection site reactions manifested as maculo-papular or acneiform rashes, erythema, 
induration, pruritis and pain, topical application of cool compresses, antihistamine or 
corticosteroids may be used. If needed, systemic antihistamines and antipyretics may be added. 

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7. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
7.1. 
Subject Inclusion Criteria 
Subjects must meet the following criteria on screening examination to be eligible to participate in 
the trial: 
1. Male or female subjects aged ≥18 years  
2. Histologically or cytologically confirmed diagnosis of solid tumor 
3. Depending on the clinical site ability to access acceptable tumor sample for analysis: 
available tumor sample and EDTA blood sample for central lab WES biomarker analysis 
(preferable) or a blood sample for central lab plasma RAS ctDNA assay, which 
demonstrates at least 1 of the 2 mKRAS/NRAS alleles (eg, G12D or G12R) targeted by 
ELI-002 2P 
4. High relapse risk, as evidenced by biomarker data with the last value obtained 21 days 
after surgery or last administration of adjuvant therapy, whichever comes last in the 
specific subject's treatment plan (values must not be attributable to a non-cancer 
condition, such as pancreatitis, peritonitis, postoperative leak/fistula, or biliary 
obstruction) as follows: 
a. ctDNA blood test positive, or 
b. successive rising values (≥1 week apart) in a serum tumor biomarker (such as 
CA19-9, CEA, and CA-125), or 
c. individual biomarker values CA19-9 ≥90 U/mL, or CEA ≥15 ng/mL, or CA-125 
≥35 U/mL  
5. If subject has PDAC: 
a. Stage I, II, III or Stage IV oligometastatic (<3 lesions in one organ) disease per 
current American Joint Committee on Cancer (AJCC) staging criteria, with 
radiographic NED (no evidence of disease) status following surgery. Equivocal 
radiographic findings (eg, subcentimeter lesions, potential resolving soft tissue 
changes after surgery) are acceptable. 
b. Prior treatment with a standard of care chemotherapy or 
chemotherapy/chemoradiation (eg, FOLFIRINOX, gemcitabine/nab-paclitaxel, or 
5-FU/capecitabine) according to NCCN pancreatic cancer guidelines and 
administered in neoadjuvant and/or adjuvant setting  
c. Successful surgical resection (focal use of intraoperative irreversible electroporation 
(eg, Nanoknife®) is permitted): Complete resection (R0) or with microscopic residual 
disease (R1) 
6. If subject has CRC: 
a. High risk Stage II (T4N0), Stage III (T4N1-2/TanyN2), or Stage IV oligometastatic 
disease per current AJCC staging criteria, with radiographic NED status following 
surgery. Equivocal radiographic findings (eg, subcentimeter lesions, potential 
resolving soft tissue changes after surgery) are acceptable. 

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b. Prior treatment with standard of care chemotherapy (eg, FOLFOX, CAPEOX) 
according to NCCN colon cancer guidelines and administered in neoadjuvant and/or 
adjuvant setting 
c. If the subject has rectal cancer, prior treatment with standard of care chemoradiation 
(eg, 5-FU or capecitabine- based) according to NCCN rectal cancer guidelines and 
administered in the neoadjuvant or adjuvant setting, or as total neoadjuvant therapy 
d. For non-rectal subjects, successful surgical resection (focal use of intraoperative 
irreversible electroporation (eg, Nanoknife®) is permitted): Complete resection (R0) 
or with microscopic residual disease (R1) 
7. If the subject has NSCLC Stage IB, II, or III disease per current AJCC staging criteria 
(8th edition) with receipt of stage-appropriate standard of care therapy per NCCN 
guidelines. The criteria below are examples of current common clinical scenarios based 
on stage. Since some agents are recently approved for specific clinical settings, 
alternative historical standard of care regimens will be allowed with approval of the 
medical monitor. 
a. Stage IB (T3-T4): complete surgical resection (R0). Prior systemic therapy is not 
required. 
b. Stage II: 
i. neoadjuvant SOC platinum-based chemotherapy according to NCCN guidelines 
with checkpoint inhibitor (if the tumor is ≥4 cm or node positive), followed by 
complete surgical resection (R0) 
ii. complete surgical resection (R0), followed by adjuvant chemotherapy with a SOC 
platinum doublet (eg, cisplatin/pemetrexed, cisplatin/gemcitabine, 
cisplatin/docetaxel, cisplatin/vinorelbine, or carboplatin/paclitaxel) and 
checkpoint inhibitor (if the tumor is >1% PDL1+) according to NCCN guidelines 
c. Resectable Stage III:  
i. Prior standard of care neoadjuvant platinum-based chemotherapy: 
a) with or without checkpoint inhibitor (if the tumor is ≥4 cm or node positive), 
followed by complete surgical resection (R0) 
b) with or without radiation, followed by complete surgical resection (R0), 
followed by checkpoint inhibitor (if the tumor is >1% PDL1+) 
ii. Complete surgical resection (R0) followed by SOC adjuvant platinum-based 
chemotherapy (with or without radiation for N2 disease) followed by a checkpoint 
inhibitor (if the tumor is >1% PDL1+) according to NCCN guidelines 
d. Unresectable Stage III: concurrent standard of care chemotherapy and radiation 
followed by consolidation with checkpoint inhibitor regardless of PDL1 expression 
e. Equivocal radiographic findings (eg, subcentimeter lesions, potential resolving soft 
tissue changes after surgery) are acceptable. 
8. If subject has ovarian cancer: 
a. Stage II, III or IV disease per current AJCC staging criteria, including ovarian, 
fallopian tube and primary peritoneal cancers or borderline tumors 
Primary debulking surgery with optimal cytoreduction (residual disease <1cm [R1] or 
removal of macroscopic disease [R0]) followed by six cycles of standard of care 
platinum-based adjuvant chemotherapy (eg, paclitaxel 175/carboplatin or pyrimidine-

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based 5-FU/leucovorin/oxaliplatin or capecitabine/oxaliplatin) or neoadjuvant 
standard of care platinum-based chemotherapy with interval debulking surgery for 
subjects who were not candidates for primary debulking surgery due to disease 
unlikely to be optimally cytoreduced, followed by standard of care adjuvant platinum 
or pyrimidine based chemotherapy (eg, paclitaxel 175/carboplatin, or 
5-FU/leucovorin/oxaliplatin or capecitabine/oxaliplatin). Equivocal radiographic 
findings (eg, potential resolving soft tissue changes after surgery) are acceptable. 
9. If subject has CCA or gallbladder carcinoma: 
a. Localized and surgically resected intrahepatic, perihilar or distal CCA, or surgically 
resected gallbladder carcinoma (focal use of intraoperative irreversible 
electroporation (eg, Nanoknife®) is permitted) with complete resection (R0) or 
microscopic residual disease (R1). Equivocal radiographic findings (eg, 
subcentimeter lesions, potential resolving soft tissue changes after surgery) are 
acceptable. 
b. For subjects with CCA and R0 resection, observation or standard of care adjuvant 
treatment or chemoradiation per the list below; for CCA and R1 resection, standard of 
care adjuvant treatment or chemoradiation per the list below 
c. For subjects with gallbladder carcinoma (with either R0 or R1 resection), standard of 
care neoadjuvant, adjuvant or chemoradiation per the list below 
Neoadjuvant (gallbladder only) eg, 5-FU oxaliplatin, capecitabine oxaliplatin, 
gemcitabine capecitabine, gemcitabine cisplatin, 5-FU cisplatin, capecitabine 
cisplatin, gemcitabine cisplatin nab-paclitaxel, gemcitabine oxaliplatin, 5-FU, 
capecitabine, gemcitabine 
Adjuvant, eg, capecitabine, 5-FU oxaliplatin, capecitabine oxaliplatin, gemcitabine 
capecitabine, gemcitabine cisplatin, 5-FU cisplatin, capecitabine cisplatin, 5-FU, 
gemcitabine (gallbladder and intrahepatic CCA only) 
Chemoradiation, eg, XRT with 5-FU, XRT with capecitabine 
10. Screening CT is negative for recurrent disease 
11. Laboratory values must be: 
a. Absolute neutrophil count ≥1.5 x 109/L 
b. Platelets ≥100 x 109/L 
c. Hemoglobin ≥9 g/dL 
d. Total bilirubin ≤1.5 x ULN, unless subject has documented Gilbert’s syndrome 
e. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 x ULN 
f. Serum creatinine <1.5 mg/dL (or if serum creatinine is ≥1.5 mg/dL, the creatinine 
clearance calculated by Cockcroft-Gault formula must be ≥60 mL/min) 
g. Albumin ≥2.5 g/dL 
h.  IL-6 < 500 pg/mL 
12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 
13. Subjects have recovered from prior surgery, chemotherapy, or radiation without any 
ongoing medical/surgical issues (excluding resolved, low grade or chronic stable findings 
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14. Women of childbearing potential and men with a female partner of childbearing potential 
must be willing to use effective methods of contraception during trial participation and 
for 30 days after the last dose of trial drug to prevent pregnancy as follows:  
a. Women: willing to use contraceptives with a failure rate <1% per year when used 
consistently and correctly, eg, combined oral contraceptives, barrier methods, 
approved contraceptive implant, long- term injectable contraception, or intrauterine 
device, sexual abstinence, or a vasectomized partner 
Definitions that meet the criteria to not be considered of childbearing potential: 
− Women >2 years postmenopausal (defined as 1 year or longer since last menstrual 
period) AND >55 years of age 
− Postmenopausal women (as defined above) and <55 years of age with a negative 
pregnancy test within 24 hours of first dose  
− Women who were surgically sterilized at least 3 months prior to enrollment 
b. Men: willing to use an acceptable method of birth control, eg, condom with 
spermicide. In addition, men must refrain from donating sperm. 
15. Able to provide written (signed) informed consent to participate in the trial prior to any 
trial specific screening procedures 
7.2. 
Subject Exclusion Criteria 
Subjects must not meet any of the following criteria on screening examination to be eligible to 
participate in the trial: 
1. Has received an anti-tumor therapy including investigational drug within 4 weeks prior to 
trial drug administration 
2. Is currently receiving any agent with a known effect on the immune system, unless at 
dose levels that are not immunosuppressive (eg, inhaled corticosteroids at doses used for 
the treatment of asthma) (see Section 8.1.1) 
3. Has any other serious illnesses or medical conditions such as, but not limited to: 
a. Any uncontrolled infection 
b. Uncontrolled cardiac failure classification III or IV (New York Heart Association) 
c. Myocardial infarction ≤6 months prior to enrollment 
d. Serious or uncontrolled cardiac arrhythmia, unstable angina 
e. History of or active seizure disorder 
f. History of or active auto-immune disease (excluding mild conditions, such as vitiligo, 
type 1 diabetes, psoriasis) 
g. History of or active interstitial lung disease/pneumonitis requiring treatment with 
systemic steroids 
h. Prior organ transplant 
4. Baseline pulse oximetry <92% on room air at screening 

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5. Known history of positive tests for human immunodeficiency virus/acquired immune 
deficiency syndrome (HIV)/AIDS or hepatitis B  
6. Hepatitis C subjects are excluded unless they have had a sustained virologic response to 
direct-acting antiviral therapy; such subjects must have an undetectable hepatitis C virus 
RNA at screening  
7. Active severe acute respiratory syndrome (SARS)-CoV-2 (excluding subjects who have 
completed 2 weeks of quarantine and are considered clinically stable per investigator 
judgement); SARS-CoV-2 antibody test positivity is permitted. 
8. Pregnant or lactating females  
9. Women of childbearing potential who have a confirmed positive pregnancy test result at 
Baseline. If the urine test is positive or cannot be confirmed as negative, a serum 
pregnancy test will be required. 
10. Had any other malignancies within the last 3 years (except for adequately treated 
carcinoma of the cervix, bladder, prostate, basal or squamous cell skin cancer), and in the 
investigator’s judgement, there is no anticipation that the patient would need treatment 
for the other malignancy in the next 2 years, except for endocrine therapy for early-stage 
tumors. 
11. Known malignant brain lesion(s). Subjects with previously treated brain metastases may 
be eligible provided they are stable (ie: without evidence of progression by imaging for at 
least 4 weeks prior to the first dose of ELI-002 7P, and any neurologic symptoms have 
returned to baseline), and there is no evidence of new or enlarging brain metastases. 
12. Pancreatic neuroendocrine tumor or germline BRCA 1/2 
13. If a subject has pancreatic cancer: 
a. Any tumor mutation where specific therapy is approved, and the subject is able to 
receive the approved therapy (except in cases where the subject cannot receive the 
approved therapy, such as due to a contraindication) 
14. If subject has CRC: 
a. Prior immunotherapy as part of their adjuvant regimen 
b. Mismatch repair defective (MSI+) 
c. Any tumor mutation where specific therapy is approved, and the subject is able to 
receive the approved therapy 
15. If subject has NSCLC:  
a. Any tumor mutation where specific therapy is approved, and the subject is able to 
receive the approved therapy 
16. If subject has ovarian cancer, BRCA 1/2 or other hereditary cancer syndrome 
7.3. 
Subject Withdrawal Criteria 
A subject may voluntarily withdraw or be withdrawn from the trial at any time for reasons 
including, but not limited to, the following: 

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• The subject wishes to withdraw from further participation. 
• The subject is significantly noncompliant with the protocol. 
• Continuation in the trial would be detrimental to the subject’s safety in the opinion of the 
investigator. 
Any subject who wishes to withdraw from the trial may do so at any time without it affecting 
their medical care. The investigator may withdraw a subject from the trial at any time if it is felt 
to be in the best interest of the subject.  
If a treated subject is discontinued prematurely from further treatment, the investigator must 
provide an explanation in the subject source records, as well as the eCRF and perform all End of 
Treatment evaluations according to Visit 15 in Table 14. These subjects should then enter the 
Follow-up Period, where procedures listed in Table 15 will be performed. In the event that a 
subject will not continue to be evaluated in the Follow-up Period, the End of Study visit 
(Visit 24) should be scheduled, and all procedures performed. 
In the event that a subject does not return for the Follow-up evaluations, the investigator must 
make every effort to contact the subject to review all AEs and to determine the reason for 
dropping out (see Section 7.3.2). 
In the event that a subject discontinues prematurely due to an AE or SAE assessed to be study 
drug-related, the event should be followed until it resolves (returned to normal or baseline 
values), stabilizes, or is judged by the investigator to be no longer clinically significant. 
Follow-up of an AE may also be continued at the request of the Sponsor Medical Monitor. 
7.3.1. 
Subject Replacement 
If a subject discontinues for any reason other than toxicity prior to completing 28 days of 
ELI-002 therapy, a replacement subject will be added to the cohort until 3 subjects per cohort 
complete 28 days of ELI-002 therapy. 
7.3.2. 
Subjects Lost to Follow-up 
If a subject is lost to follow-up, every attempt must be made to contact the subject and to 
determine the reason for dropping out. If the subject cannot be reached after three documented 
attempts over a reasonable amount of time, a certified letter must be sent to the subject asking 
them to contact the trial center for follow-up. Only after all above documented attempts will a 
subject be considered lost to follow-up. 

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8. 
TREATMENT OF SUBJECTS 
8.1. 
Concomitant Medications 
Subjects should receive medication appropriate to their health condition during the entire trial. All 
concomitant medications during the length of the trial, including screening, will be documented in 
the subject source record and in the appropriate electronic case report form (eCRF) page. 
8.1.1. 
Prohibited Concomitant Medications 
The following concomitant medications should not be used during study drug administration and 
are criteria for permanent stopping of the trial treatment administration for an individual subject 
• Growth factors (except erythropoietin). The effect of growth factor administration on 
expansion and persistence of ELI-002 is unknown. 
• Corticosteroids and other immunosuppressive agents except as needed for 
management of safety events. Systemic immunosuppressive agents should not be 
used while in the trial, except if needed for counteracting an AE, eg, cytokine release 
syndrome. However, the use of corticosteroids for anti-allergic reaction/symptoms, 
eg, pre/post tumor imaging (contrast product); topical and inhaled steroids are 
permitted. 
• Cytotoxic agents and any other cancer therapy  
• Investigational products/devices 
8.2. 
Treatment Compliance 
All subjects are expected to be fully complaint throughout the trial (see Section 6.7.2).  
Subjects will receive SC injections of ELI-002 by qualified site staff who are under the 
supervision of the investigator or designee. 
Treatment administration will be recorded on the eCRF. 
8.3. 
Randomization and Blinding 
ELI-002 is an open-label, Phase 1 trial with a single arm. Treatment will not be blinded and there 
will not be randomization as part of this study. 

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9. 
TRIAL DRUG MATERIALS AND MANAGEMENT 
9.1. 
Trial Drug 
ELI-002 is an investigational product consisting of 2 drug products:  
1. A mixture of lipid-conjugated peptide-based antigens (amphiphilic peptides, referred to 
as ‘Amph-Peptides’). During the study, the Amph-Peptide mixture (Amph-Peptides 2P) 
will be comprised of 1.4 mg of 2 Amph modified KRAS peptides, Amph-G12D, and 
Amph-G12R (0.7 mg/peptide). Elicio plans to investigate the use of an Amph-Peptide 7P 
drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, 
G13D) in future clinical trials. 
2. A lipid-conjugated immune-stimulatory oligonucleotide (‘Amph-CpG-7909’)  
The ELI-002 admixture is prepared by combining the separately provided products in a diluent 
prior to dosing. The KRAS Amph-Peptides are provided in 5.0 mM, pH 4.5 acetate buffer in a 
2-mL glass vial. The Amph-CpG-7909 is provided in water for injection (WFI) in a 2-mL glass 
vial. These 2 drug products will then be provided to the clinical pharmacy for combination with 
10X PBS (phosphate buffered saline) on a dose-by-dose basis at the proper ratio for 
administration to the subject as a drug product admixture. For further details, refer to the Product 
Manual.  
In the event of toxicity after immunization period doses, Amph-Peptides without 
Amph-CpG-7909 adjuvant may be administered during the booster period. 
The Product Manual will provide instructions for the admixing procedure as well as storage 
instructions. 
9.2. 
Trial Drug Packaging and Labeling 
The ELI-002 study product will be provided in two separate kits comprised of 10 vials of 
Amph-CpG-7909and 10 vials of Amph-Peptides respectively. In addition, kits containing 
10 vials of 10X PBS will be provided to sites. Each vial is for single use only and is labeled 
according to local regulatory requirements. ELI-002 is for subcutaneous injection. 
9.3. 
Trial Drug Storage 
The Amph-Peptides will contain a mixture of 2 KRAS Amph-Peptide drug substances. The 
Amph-Peptides are provided as a clear, colorless to slightly yellow, sterile frozen liquid. The 
recommended storage condition is -20⁰C. For further details please refer to the Product Manual. 
The Amph-CpG-7909 drug product will be a clear, colorless, sterile liquid fill for injection and 
the adjuvant will be produced by admixing with the Amph-Peptides drug product. The intended 
storage condition is -20°C. For further details please refer to the Product Manual. 
9.4. 
Trial Drug Preparation 
For details and instructions on preparation of the study drug, please see the ELI-002-001 Product 
Manual. 

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9.5. 
Administration and Dosage 
Subjects will receive SC injections of ELI-002 during the Immunization Period at Visit 3 through 
Visit 8 (Table 12). Three months after the Immunization Period, subjects will receive SC 
injections of ELI-002 during the Booster Period at Visit 12 through Visit 15 (see Section 6.1.4, 
Table 14). 
The doses evaluated in the cohorts are as shown in Table 23. All cohorts will enroll RAS 
mutated PDAC, CRC, NSCLC and OST (including ovarian, bile duct and gallbladder 
carcinoma).  
Table 23: 
Phase 1 Cohorts and Doses 
 
Cohort 
Tumor 
Dose Level 
Dose 
Escalation 
Cohort 1 
KRAS/NRAS mutated 
solid tumors 
Amph-CpG-7909 0.1 mg with Amph-Peptides 
Cohort 2 
KRAS/NRAS mutated 
solid tumors 
Amph-CpG-7909 0.5 mg with Amph-Peptides 
Cohort 3 
KRAS/NRAS mutated 
solid tumors 
Amph-CpG-7909 2.5 mg with Amph-Peptides 
KRAS=Kirsten rat sarcoma; NRAS=neuroblastoma ras viral oncogene homolog; OST=other solid tumors 
9.6. 
Trial Drug Accountability 
The investigator is responsible for trial drug accountability, reconciliation, and record 
maintenance. Drug accountability records will be maintained during the trial, including the 
amount of trial drug received from the Sponsor (or Sponsor’s designee), the amount distributed 
to each subject, and the amount of unused drug destroyed at the site or returned to the Sponsor 
for destruction. 
The trial center will maintain a log of all trial drug prepared and administered to subjects, as well 
as destruction of used/unused vials. Administration of the drug product admix (the test article) 
will occur during the Immunization Period and the Booster Period, according to the Schedule of 
Assessments (Table 12 and Table 14). 
Trial center personnel should refer to the Product Manual for instructions regarding disposal of 
any trial drug or used trial drug packaging. 
9.7. 
Trial Drug Handling and Disposal 
All used and unused trial drug supplies must remain stored at the clinical site in a secure location 
and within appropriate temperature conditions up until receiving instructions for destruction. 
Disposal of trial drug will be conducted in compliance with all applicable laws and regulations. 

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10. 
TIMING OF TRIAL PROCEDURES 
Home Health Visits: Based on assessment of risk, and to ensure subject safety and minimize 
risks to trial integrity, off-site study visits can be performed in the event a study participant 
cannot attend an on-site visit during the COVID-19 crisis [Food and Drug Guidance, 2020]. The 
procedures that cannot be performed during a home health visit include: 
• CT/MRI scans 
• First ELI-002 dose administration (Visit 3, Day 57); this must occur on-site as per 
Section 10.2. 
• Leukapheresis (Visit 2, Visit 9) 
The informed consent form will describe the availability of home health visits if applicable at the 
clinical site.  
The subject will be invited to continue future study visits on-site per protocol, as soon as local 
and federal Covid-19 regulations allow. 
10.1. 
Screening and Observation Period 
Visit 1 (Day 10), subjects will provide written informed consent before any trial-related 
procedures are performed.  
• Once a subject has consented among the first procedures will be: 
o A retrospective tumor tissue sample from the prior surgery will be 
requisitioned for WES. Tumor DNA will be sequenced to guide ctDNA 
testing in subsequent blood samples and baseline tumor gene expression will 
be assessed (Table 11).  
o In parallel, a 6-mL ethylenediaminetetraacetic acid (EDTA) whole blood tube 
will be collected and shipped at the same time as the tissue sample. The 
somatic DNA from the EDTA tube will serve as a control to ensure only 
tumor-specific DNA is included for subsequent ctDNA testing.  
At Visit 2 (Day 26 ±5 days), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Collect a urine sample for a pregnancy test for women of childbearing potential. 
• Record demographic information (including sex, age, race and ethnicity). 
• Record height and weight. 
• Record medical and medication history, including cancer history/prior treatments and 
current medications. 
• Review available eligibility criteria. While mKRAS/mNRAS and ctDNA results may 
not yet be available, the expectation is that these will be reviewed, and full eligibility 
determined, prior to Visit 3.  

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• Perform a physical examination which will be based on institution standard of 
care(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures should be performed during this 3-minute period. 
• Perform a 12-lead ECG (to be reviewed by a cardiologist or clinical investigator 
according to institutional guidelines and practice). 
• Perform an ECOG Scale of Performance Status. To be eligible, ECOG performance 
status must be 0 to 1. 
• Perform a CT with contrast within 90 days of first ELI-002 dose, following resection  
or after last administration of adjuvant treatment, whichever is last in the specific 
subject treatment plan. For subjects with IV contrast allergy/intolerance, MRI may be 
performed. The same modality should be used for all imaging throughout the trial. 
• Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). 
• Collect a sample appropriate for the available test method for active Covid-19 
infection (local laboratory).  
• Collect a blood sample for ctDNA test ≥21 days post-surgery or after last 
administration of adjuvant treatment, whichever is last in the specific subject 
treatment plan (to be performed at a central laboratory).  
• Collect blood sample(s) (local laboratory, see Inclusion Criteria #4 in Section 7.1). 
Biomarker values must be obtained ≥21 days post-surgery or after the last 
administration of adjuvant therapy, whichever comes last in the specific subject’s 
treatment plan. 
• Collect a leukapheresis for immunogenicity assessment (central laboratory). The 
leukapheresis must be collected once eligibility has been confirmed and prior to the 
first dose of ELI-002. 
• Record any pre-treatment SAEs that have occurred. 
10.1.1. 
Rescreening 
Subjects are allowed to rescreen for the ELI-002-001 trial. No screening procedures, other than 
what may need to be repeated due to screen failure, will need to be repeated as long as the 
screening CT/MRI scan was performed ≤90 days from the time of the anticipated first dose of 
trial drug. If the CT/MRI scan was performed >90 days from the anticipated first dose, then it 
will need to be repeated and reviewed, to ensure that the patient is negative for recurrent disease, 
per the protocol inclusion criteria. 
Other screening evaluations can be repeated as deemed appropriate and necessary by the 
investigator. 

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10.2. 
Immunization Period 
During the Immunization Period, subjects will receive 4 weekly SC injections (Weeks 1 to 4) 
followed by 2 injections at Week 6 and Week 8 (Table 12). If the subject has fever ≥38.0°C 
and/or elevated IL-6 ≥500 pg/mL, proceed with the visit but omit study treatment administration; 
if fever abates and cytokines diminish to <500 pg/mL, the subject may proceed with the next 
scheduled dose after approval from the medical monitor). In addition, if a subject exhibits IFNγ 
≥1000 pg/mL, the Elicio medical monitor should be contacted for consultation. 
All laboratory samples should be taken prior to dosing on any study visit that has dosing. 
At Visit 3 (Baseline, Day 57) prior to trial drug administration, the following visit procedures 
will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Record any change in medical history since the previous visit. Subjects must have 
recovered from surgery without any ongoing medical/surgical issues. 
• Record any change in cancer history since the previous visit. 
• Perform a physical examination which will be based on institution standard of care 
(see Section 12.1.3). In addition, a neurological examination for baseline assessment 
of ICANS/ICE will be performed. 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate).  
• Record weight. 
• Perform a 12-lead ECG (to be reviewed by a cardiologist or clinical investigator 
according to institutional guidelines and practice). 
• Confirm ECOG Scale of Performance Status is 0 or 1. 
• Record any change in concomitant medications since the previous visit. 
• Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine testing 
should be performed within 7 days prior to dosing. 
• Collect a blood sample for ctDNA (to be performed at a central laboratory). 
• Collect a blood sample for high resolution HLA typing (central laboratory).  
• Record any pre-treatment SAEs that have occurred since the previous visit.  
Dose 1: The first dose must be administered at the clinical site. Subjects must be observed by 
study staff for at least 1-hour postdose for observation and must stay within an hour of the clinic 
for ≥24 hours in order to monitor for potential AEs such as CRS. 
After dose administration the following visit procedures will occur: 

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• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 4 (Day 64), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
• Record any AEs since last visit. Check for signs of toxicity. Including fever, and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation(Section 6.8.1).  
• Dose 2: Trial drug administration and subjects must be observed by study staff for at 
least 1-hour postdose for observation. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 5 (Day 71), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 

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• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
− Collect a whole blood sample for immunogenicity testing (central laboratory). 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 3: Trial drug administration and subjects must be observed for safety for at least 
1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 6 (Day 78), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 

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− Collect a blood sample for ctDNA.  
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 4: Trial drug administration and subjects must be observed for safety for at least 
1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 7 (Day 92), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
− Collect a whole blood sample for immunogenicity testing (central laboratory). 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 5: Trial drug administration and subjects must be observed for safety for at least 
1-hour post dose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 

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At Visit 8 (Day 106), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 6: Trial drug administration and subjects must be observed for safety for at least 
1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
10.3. 
No Dosing 3-Month Period 
After the Immunization Period, subjects will be observed during a No Dosing 3-Month Period 
(Table 13). 
At Visit 9 (Day 120), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 

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• Record weight. 
• Record any change in concomitant medications since the previous visit. 
• Collect a blood sample for clinical laboratory assessments (local laboratory; see 
Section 12.1.6). 
• Collect leukapheresis for immunogenicity assessments (central laboratory). This 
procedure may be performed -7 days to +3 days from Visit 9. 
• Record any AEs since last visit. 
At Visit 10 (Day 148) and Visit 11 (Day 176), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Record any change in concomitant medications since the previous visit. 
• At Visit 10 (Day 148 [±14 days]) only perform a CT with contrast. For subjects with 
IV contrast allergy/intolerance, MRI may be performed. The same modality as the 
screening imaging assessment should be used throughout the trial. 
• Collect a blood sample for clinical laboratory assessments (local laboratory; see 
Section 12.1.6). 
− At Visit 11 (Day 176) only – collect a blood sample for the cytokine panel (local 
laboratory; see Section 11.1). Note: cytokine testing should be performed and 
reviewed within 7 days prior to dosing. 
• At Visit 10 (Day 148 [±14 days]) only collect a serum sample for CA-125/CA 19-
9/CEA for appropriate tumor type (local laboratory).  
• At Visit 11 (Day 176) only collect a blood sample for ctDNA (to be performed at a 
central laboratory): 
• At Visit 11 (Day 176) collect a whole blood sample for immunogenicity testing 
(central laboratory) 
• Record any AEs since last visit. 
10.4. 
Booster Period 
During the Booster Period, eligible subjects will receive booster vaccinations, consisting of 
4 weekly injections (Table 14). If the subject has fever ≥38.0°C and/or elevated IL-6 
≥500 pg/mL, proceed with the visit but omit study treatment administration; if fever abates and 

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cytokines diminish to <500 pg/mL, the subject may proceed with the next scheduled dose after 
approval from the medical monitor). In addition, if a subject exhibits IFNγ ≥1000 pg/mL, the 
Elicio medical monitor should be contacted for consultation. 
At Visit 12 (Day 196), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
− Collect a blood sample for ctDNA (to be performed at a central laboratory). 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 7: Trial drug administration and subjects must be observed for safety for at least 
1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 13 (Day 203), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 

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• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 8: Trial drug administration and subjects must be observed for safety for at least 
1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 14 (Day 210), the following visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
− Collect a whole blood sample for immunogenicity testing (central laboratory). 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 

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present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 9: Trial drug administration and subjects must be observed for safety for at least 
1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 
At Visit 15/ End of Treatment (Day 217), this visit is to be performed when the subject 
completes the treatment period or if they discontinue treatment early and prior to entering the 
follow-up period of the study. The visit procedures will include: 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
• Confirm ECOG Scale of Performance Status. 
• Record any change in concomitant medications since the previous visit. 
• All laboratory samples should be taken prior to dosing on any study visit that has 
dosing. 
− Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). Note: cytokine 
testing should be performed and reviewed within 7 days prior to dosing. 
• Record any AEs since last visit. Check for signs of toxicity, including fever and 
laboratory evidence of elevated cytokines. Hold the ELI-002 dose if Grade ≥2 CRS is 
present, or if elevated cytokine IL-6 is present. If elevated IFNγ is present, the Elicio 
medical monitor should be contacted for consultation (Section 6.8.1). 
• Dose 10: Trial drug administration and subjects must be observed for safety for at 
least 1-hour postdose. 
• Subjects will be provided with the reactogenicity diary to complete for 7-days 
following the dose. Subjects will be instructed how to complete the diary and to 
return the completed form at their next visit. 

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10.5. 
Follow-up Period 
A Follow-up Period will provide safety and efficacy data (Table 15 and Table 16). 
At every visit during the Follow-up Period, Visit 16 (Day 231), Visit 17 (Day 259), Visit 18 
(Day 315), Visit 19 (Day 399), Visit 20 (Day 483), Visit 21 (Day 567), Visit 22 (Day 651), 
Visit 23 (Day 735), Visit 24 (Day 819), Visit 25 (Day 903), Visit 26 (Day 987), Visit 27 (Day 
1071) and Visit 28/End of Study (Day 1127), the following visit procedures will include: 
• Confirm ECOG Scale of Performance Status. 
• Collect a blood sample for ctDNA test (central laboratory). 
• Record any AEs that occur within 30 days of last dose and follow any such AEs until 
they resolve or return to baseline level.  
In addition, the following assessments will be conducted at these Follow-up visits: 
At Visit 16 (Day 231), the following visit procedures will include 
• Collect a blood sample for clinical laboratory assessments, including the cytokine 
panel (local laboratory; see Section 11.1 and Section 12.1.6). 
• Collect a whole blood sample for immunogenicity testing (central laboratory). 
At Visit 16 (Day 231), Visit 17 (Day 259), Visit 18 (Day 315), Visit 19 (Day 399), Visit 20 
(Day 483), Visit 21 (Day 567), Visit 22 (Day 651), Visit 23 (Day 735), and Visit 24 (Day 819) 
the following visit procedures will include 
• Administer the EORTC QLQ-C30 and the tumor type-specific PRO (see 
Section 11.3). 
• Record vital signs (blood pressure, pulse rate, body temperature, and respiratory rate). 
Measurements will be obtained after 3 minutes in the sitting position. No other 
measurements or procedures were performed during this 3-minute period. 
• Record weight. 
At Visit 17 (Day 259), Visit 19 (Day 399), Visit 20 (Day 483), Visit 21 (Day 567), Visit 22 
(Day 651), Visit 23 (Day 735), Visit 24 (Day 819), Visit 25 (Day 903), Visit 26 (Day 987), 
Visit 27 (Day 1071), and Visit 28/End of Study (Day 1127), the following visit procedures will 
include: 
• Perform a CT (±14 days) with contrast. For subjects with IV contrast 
allergy/intolerance, MRI may be performed. The same modality as the screening 
imaging assessment should be used throughout the trial. 
• Collect a serum sample for CA-125/CA 19-9/CEA for appropriate tumor type (local 
laboratory).  
At Visit 20 (Day 483), the following visit procedures will include: 
• Perform a physical examination, which will be based on institution standard of care 
(see Section 12.1.3). 
At Visit 22 (Day 651), the following visit procedures will include: 

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• Collect a whole blood sample for immunogenicity testing (central laboratory). 
The Visit 28/End of Study visit will be scheduled for subjects who complete the study or for 
any subject that discontinues from the study early. 

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11. 
CLINICAL ACTIVITY, IMMUNE ASSESSMENTS, AND 
SUBJECT REPORTED OUTCOMES 
Clinical activity, immune assessments, and PROs will be collected according to the Schedule of 
Assessments (Table 11, Table 12, Table 13, Table 14, Table 15, and Table 16). 
Median RFS and 1-year RFS rate will be assessed through CT imaging with contrast as assessed 
by the site investigators using iRECIST criteria [Seymour et al, 2017]; subjects will be followed 
for OS. Unscheduled CT or MRI imaging may be performed at any time, if the investigator 
determines that there are clinical signs of disease progression.  
In addition, biomarker response rate will be based on the percentage of subjects achieving 
biomarker reduction or clearance, as measured by the absence or decrease of ctDNA from 
baseline and the duration of ctDNA clearance and/or reduction, or if ctDNA was not detectable 
at baseline, serum tumor biomarker (such as carbohydrate antigen [CA]19-9, carcinoembryonic 
antigen [CEA], and CA-125) reduction and clearance compared to baseline will be recorded. 
T cell responses in PBMCs will be assessed by immune assays such as IFN Fluorospot, ICS, 
and/or dextramers.  
Immune responses will be correlated to clinical efficacy parameters. 
11.1. 
Immunogenicity 
Patients will have leukapheresis and blood samples drawn to evaluate the immunogenicity of 
ELI-002. T cell responses in PBMCs will be assessed by immune assays such as IFN 
Fluorospot, ICS, and/or dextramers. Serum cytokine, CA-125, CEA and CA 19-9 levels will also 
be examined.  
HLA Typing: High resolution HLA typing will be used to identify certain individual variations 
in the immune system. Cohorts will be enrolled regardless of the HLA subtype.  
Serum Cytokines: Concentrations of cytokines, IL-2, IFNγ, IL-6, IL-10, and TNFα, will be 
measured using multiplex technology in serum samples (local laboratory). 
Cellular immune response: The cellular immune response to ELI-002 will be monitored by 
examining T cell responses using immune assays such as Fluorospot and ICS. The Fluorospot 
assay enumerates the release of IFN in human PBMCs following KRAS peptide stimulation. 
The ICS assay is a flow cytometry-based assay that can detect cytokine production by CD4+ and 
CD8+ T cells to the KRAS peptides. For both assays, PBMCs will be stimulated individually 
with mKRAS peptide pools  to determine the frequency of KRAS-specific T cells per patient and 
timepoint. Dextramers are fluorescently labeled HLA multimers that can detect antigen-specific 
T cells. In subjects with HLA alleles for which dextramer(s) are available, the frequency of 
KRAS-specific T cells can be monitored in PBMCs before and after vaccination. 
Full details of the leukapheresis or phlebotomy procedure to obtain PBMCs will be provided in 
the Central Laboratory Manual.  
Standard of Care Biopsies:  Tumor tissue specimens will be collected post-dosing from 
biopsies performed as standard of care per iRECIST criteria (ie; following observation of new 
lesions on radiographic imaging and investigator assessment that tissue can be safely obtained).  
If there is sufficient sample collected, the pathology laboratory should perform in situ gene 

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expression and/or IHC staining to examine tumor-infiltrating T cells and the tumor 
microenvironment. 
11.2. 
Tumor Tissue Collection at Surgery 
Once a subject has consented, and depending on the clinical site location, the trial coordinator 
will requisition a tumor tissue sample that was collected at surgery. Details for tumor tissue 
collection are provided in the Central Laboratory Manual). 
11.3. 
Patient Reported Outcomes 
Patient reported outcomes will be assessed by EORTC QLQ-C30 and QLQ-PAN26, QLQ-CR29, 
QLQ-OV28, QLQ-BIL21 or QLQ-LC13 and will be administered to subjects according to the 
Schedule of Assessments and prior to other visit procedures (Table 11, Table 12, Table 13, 
Table 14, Table 15, and Table 16). All the PROs have been fully validated by EORTC, except 
QLQ-PAN26, which has completed phase III of validation and is on-track for full validation in 
2021. Verification of validation can be obtained through EORTC, and the list of questionnaires 
and the phase of validation can be found at the following site: 
https://qol.eortc.org/questionnaires/. 
11.3.1. 
EORTC QLQ-C30 
The European Organization for Research and Treatment of Cancer quality of life questionnaire 
(EORTC QLQ-C30) is a tool for assessing the quality of life (QoL) of cancer subjects 
participating in clinical trials. The EORTC QLQ-C30 incorporates 9 multi-item scales: 
5 functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); 3 symptom 
scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single 
item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and 
Financial Difficulties). The psychometric properties of the questionnaire have been determined 
to be valid, reliable, and sensitive [Aaronson et al, 1993; Osoba et al, 1994; Kaasa et al, 1995]. 
11.3.2. 
Tumor type-specific PROs 
Tumor type-specific PROs are intended to supplement the EORTC QLQ-C30 with questions 
appropriate for the symptoms experienced by subjects with each tumor type. Please refer to the 
EORTC website for the PRO validation documentation. Tumor type-specific PROs will include: 
• QLQ-PAN26: pancreatic cancer  
• QLQ-BIL-21: biliary cancer 
• QLQ-CR-29: colorectal cancer  
• QLQ-LC-13: lung cancer  
• QLQ-OV-28: ovarian cancer 

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11.4. 
ctDNA Levels 
Levels of ctDNA (mean tumor molecules/mL) will be assessed using a ctDNA assay (central 
laboratory) in anticoagulated peripheral whole blood at indicated timepoints post vaccination. 
The ctDNA fold change from baseline will be calculated at each timepoint.  
If a subject is MRD- by ctDNA at screening, sites may continue to monitor ctDNA levels per 
their standard of care testing and rescreen if the subject becomes MRD+ by ctDNA analysis. It is 
recommended that the time between ctDNA screening tests be ≥90 days. 

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12. 
ASSESSMENT OF SAFETY 
12.1. 
Safety Parameters 
12.1.1. 
Demographics and Medical History 
Demographic variables will include age, gender, and race/ethnicity. Medical and medication 
history, including cancer history/prior treatments, current medications (prescription, herbal and 
dietary supplements, over-the-counter medications, and topical treatments), smoking history (for 
NSCLC subjects only), and diseases will be assessed at Screening and recorded in the source 
documents and the eCRF. 
Weight and height will be collected during the Screening Period and weight will collected 
throughout the trial according to the Schedule of Assessments (Table 11, Table 12, Table 13, 
Table 14, Table 15, and Table 16). 
12.1.2. 
Vital Signs 
Vital signs will be collected throughout the trial according to the Schedule of Assessments 
(Table 11, Table 12, Table 13, Table 14, Table 15, and Table 16) and will include blood 
pressure, pulse rate, body temperature, and respiratory rate. Measurements will be obtained after 
3 minutes in the sitting position. No other measurements or procedures were performed during 
this 3-minute period. 
12.1.3. 
Physical Examinations 
Full or targeted PEs will be performed at screening and at specified times during the trial 
(Table 11, Table 12, Table 13, Table 14, Table 15, and Table 16) based on standard of care. 
12.1.4. 
Electrocardiogram 
A resting 12-lead ECG will be performed according to the Schedule of Assessments (Table 11 
and Table 12) and reviewed by a cardiologist or clinical investigator, per institutional guidelines 
and practice.  
12.1.5. 
Eastern Cooperative Oncology Group 
The ECOG Scale of Performance Status describes a subject’s level of functioning in terms of 
their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).  
Eligibility for this trial requires a subject’s ECOG performance status to be 0 to 1 (see Table 24).  
The ECOG assessment will be performed according to the Schedule of Assessments (Table 11, 
Table 12, Table 13, Table 14, Table 15, and Table 16). 
12.1.6. 
Laboratory Assessments 
Laboratory tests will be performed according to the Schedule of Assessments (Table 11, 
Table 12, Table 13, Table 14, and Table 15). A central clinical laboratory will be utilized for 
biomarkers, but local clinical laboratories will be used for safety assessments.  

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The results of clinical laboratory tests conducted during the trial will be assessed by the 
investigator to determine each subject’s appropriateness for trial participation.  
For the remainder of the trial, the investigator will review laboratory values that are outside the 
normal reference ranges to determine whether the values are clinically significant. Clinically 
significant changes will be followed until the parameter returns to Baseline or until the 
investigator determines that follow-up is no longer medically necessary. Clinically significant 
values will be documented as Adverse Events as described in Section 12.2.1.1. Unscheduled 
re-tests may be performed as needed through the Follow-up Visit. 
12.1.6.1. Hematology 
The following hematology parameters will be assessed: 
• White blood cell count 
• Red blood cell count 
• Absolute/% Neutrophils 
• Hematocrit 
• Absolute/% Lymphocytes 
• Hemoglobin 
• Absolute/% Monocytes 
• Platelet Count 
• Absolute/% Eosinophils 
• Absolute/% Basophils 
12.1.6.2. Coagulation  
The following coagulation parameters will be assessed: 
• Prothrombin time (PT)  
• Partial Thromboplastin time (PTT) 
• International Normalized Ratio (INR) 
• Fibrinogen 
• D-dimer 
12.1.6.3. Blood Chemistry 
The following blood chemistry parameters will be assessed: 
• Sodium 
• Lactate dehydrogenase 
• Potassium 
• Blood urea nitrogen (BUN) 
• Chloride 
• BUN/creatinine ratio 
• Creatinine 
• Bilirubin (total) 
• Calcium 
• Protein (total) 
• Phosphate 
• Albumin 
• Glucose 
• Uric acid 
• Alkaline phosphatase 
• Aspartate transaminase (AST) 

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• Bicarbonate 
• Alanine transaminase (ALT) 
• LDH 
• Creatine kinase  
• Magnesium 
• Ferritin 
 
• C-reactive protein (CRP) 
12.1.6.4. Serum Cytokines 
The following serum cytokines will be assessed: 
• IL-2 
• IFNγ 
• IL-6 
• IL-10 
• TNFα 
12.1.6.5. Viral Laboratory Testing at Screening 
The following viral parameters will be assessed at Screening only: 
• Hepatitis C RNA 
• COVID-19 active infection 
12.1.6.6. Pregnancy Screen 
A urine pregnancy test will be performed according to the Schedule of Assessments (Table 11) 
for women of childbearing potential. Postmenopausal women must have been amenorrhoeic for 
at least 12 months to be considered of non-childbearing potential. Childbearing status for all 
women will be recorded in the source documents and in the eCRF. 
A positive pregnancy test will exclude the subject from participation in the trial. Any clinically 
abnormal or inconclusive test will be repeated. 
12.2. 
Adverse and Serious Adverse Events 
12.2.1. 
Definition of Adverse Events 
12.2.1.1. Adverse Event 
An AE is the development of an undesirable medical condition or the deterioration of a 
pre-existing medical condition following or during exposure to a pharmaceutical product, 
whether or not considered study-drug related. An AE can be any unfavorable and unintended 
sign, symptom of disease temporally associated with the use of study drug, without any 
judgement about causality (see current ICH guidelines). 
In this study, investigators should report AEs based on CTCAE v5.0 criteria, or ASTCT 
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syndrome (ICANS). Treatment-emergent AEs (TEAEs) are defined as events not present prior to 
the initiation of study drug or any event already present that worsens in either intensity of 
frequency following exposure to study treatment. AEs must be recorded in the eCRF and on 
forms as provided by Elicio. 
An AE does not include the following: 
• Medical or surgical procedures (eg, surgery, endoscopy, dental extraction, transfusion); 
the condition that necessitates the procedure is the AE 
• Any pre-existing disease or condition, or laboratory or ECG abnormality, which is 
present prior to the start of the study medication and that does not worsen 
• Laboratory or ECG abnormalities without clinical significance (ie, those which do not 
require medical intervention or that do not result in discontinuation or interruption of the 
study drug) 
• Situations where an adverse medical event has not occurred (ie, hospitalization for 
elective surgery, social admission) 
• Overdose of study medication or any concomitant medication without any signs or 
symptoms, unless the subject is hospitalized for observation 
The time period for collecting and documenting AEs for each subject begins from the time the 
subject is administered the first dose of study drug through end of treatment (EOT) or early 
discontinuation of treatment. 
12.2.1.2. Serious Adverse Event 
An SAE is an AE occurring during any trial phase (ie, screening, treatment, or follow-up), and at 
any dose of the investigational product, that fulfils one or more of the following: 
• Results in death 
• It is immediately life-threatening 
• It requires inpatient hospitalization or prolongation of existing hospitalization 
• It results in persistent or significant disability or incapacity 
• Results in a congenital abnormality or birth defect 
• It is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above. 
The time period for collecting and documenting SAEs for each subject begins from the time the 
subject provides informed consent through the end of study (EOS) or early discontinuation from 
the study. For this study, the reporting of CRS and/or ICANS/Neurotoxicity events will follow 
the SAE timelines and reporting requirements. 
12.2.1.3. Reactogenicity to the Vaccine 
Injection site reactions, skin rash, and pruritis will not be considered a DLT or safety event and 
should be recorded in the patient diary and eCRF for reactogenicity. (See Section 6.7.3 for DLT 

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Guidelines, Section 6.8.5 for toxicity management, and Section 12.2.1.2 for SAE definition.) 
Severe skin rashes such as Steven-Johnson Syndrome or toxic epidermal necrolysis (TEN) will 
be considered a DLT and should be reported on the eCRF as safety events including SAE as 
appropriate. Reactogenicity monitoring will include subject’s reactogenicity to the trial drug 
(vaccine). This will be captured at several time points as follows:  
• 1-hour post ELI-002 dose administration (subjects will be observed in the clinic for at 
least 1-hour after each dose) 
• 1-week post ELI-002 dose administration (subjects will record daily observations in 
diary) 
• Any unresolved reactogenicity event should be followed until resolution. 
12.2.1.4. Cytokine Release Syndrome  
The definition, management, and grading of CRS are provided in Section 6.8. 
12.3. 
Relationship to Trial Drug 
An investigator who is qualified in medicine must make the determination of relationship to the 
investigational product for each AE (Unrelated, Possibly Related, or Related). The investigator 
should decide whether, in his or her medical judgement, there is a reasonable possibility that the 
event may have been caused by the investigational product.  
Unrelated: The AE is definitely not associated with the study drug administration and is judged 
related to causes other than the study drug. 
Possibly Related (Suspected Adverse Reaction [SAR]): A causal relationship between treatment 
with the study drug and the AE is at least a reasonable possibility, ie, the relationship cannot be 
ruled out. This implies a lesser degree of certainty about causality than a related AE. Additional 
evidence to suggest a SAR includes: 
• 
Occurrence of uncommon AEs that are known to be strongly associated with drug 
exposure (eg, anaphylaxis, angioedema, blood dyscrasias, rhabdomyolysis, hepatic 
injury, Stevens-Johnson Syndrome) 
• 
Occurrence of AEs that are uncommon in the study population, but not commonly 
associated with drug exposure (eg, intussusception in healthy infants) 
Related (Adverse Reaction): A causal relationship between the study drug administration and the 
AE is definite. 
If the relationship between the AE/SAE and the investigational product is determined to be 
“possible” the event will be considered related to the investigational product for the purposes of 
expedited regulatory reporting. 

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12.4. 
Severity of Adverse Events 
The CTCAE Version 5 displays Grades 1 through 5 with unique clinical descriptions of severity 
for each AE based on this general guideline: 
• Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated  
• Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age 
appropriate instrumental activities of daily living (such as preparing meals, shopping 
for groceries or clothes, using the telephone, managing money, etc.)  
• Grade 3 Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care activities of daily living (such as bathing, dressing and undressing, feeding 
self, using the toilet, taking medications, and not bedridden)  
• Grade 4 Life-threatening consequences; urgent intervention indicated 
• Grade 5 Death related to AE. 
For CRS/ICANs, AEs will be graded according to the ASTCT criteria (Table 18 and Table 21). 
12.5. 
Recording Adverse Events 
Adverse events spontaneously reported by the subject and/or in response to an open question 
from the trial personnel or revealed by observation will be recorded during the trial at the 
investigational trial center. Treatment emergent AEs (TEAEs) are defined as events not present 
prior to the initiation of study drug or any event already present that worsens in either intensity 
of frequency following exposure to study treatment. AEs must be recorded in the eCRF and on 
forms as provided by Elicio. The AE term should be reported in standard medical terminology 
when possible. For each AE, the investigator will evaluate and report the onset (date and time), 
resolution (date and time), severity, causality, action taken, outcome, and whether or not it 
caused the subject to discontinue the trial. 
Severity will be assessed according to CTCAE or ASTCT as appropriate for the event. For AEs 
not described in the consensus criteria, the following scale will be used: 
• Mild (awareness of sign or symptom, but easily tolerated. Concomitant prescription 
medications are not ordinarily needed for relief of symptoms) 
• Moderate (discomfort sufficient to cause interference with normal activities. Concomitant 
prescription medications/treatment(s) may be needed for relief of symptoms) 
• Severe (incapacitating, with inability to perform normal activities. Requires interruption 
or discontinuation of study medication. Systemic drug therapy or other treatment is 
needed) 
Reactogenicity will be assessed according to the toxicity grading scale for local reactions for 
preventive vaccines (see Section 12.2.1.3). 

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It is important to distinguish between serious and severe AEs. Severity is a measure of intensity 
whereas seriousness is defined by the criteria under Section 12.2.1.2. An AE of severe intensity 
may not be considered serious. 
12.6. 
Pregnancy 
Should a pregnancy occur within 30 days of the last ELI-002 dose in a female subject, or in the 
partner of a male subject, it must be reported on Elicio’s paper pregnancy form. Neither 
pregnancy itself nor an induced elective abortion to terminate a pregnancy for non-medical 
reasons is considered an AE. However, an induced therapeutic abortion to terminate a pregnancy 
due to complications or other medical reasons will be recorded as an SAE. The underlying 
medical reason for this procedure should be recorded as the AE term. Pregnancy outcomes 
considered to be SAEs are: 
• Spontaneous abortion (miscarriage) 
• Stillbirth 
• Induced therapeutic abortion to terminate pregnancy due to complications or other 
medical reasons 
• Neonatal death; this includes all neonatal deaths that occur within 1 month of the 
expected birthdate (ie, either before or after the expected birth date) 
• Infant death occurring 1 month after birth, if the investigator assesses the death as 
possibly related to in utero exposure to study treatment 
• Congenital anomaly (in live birth or aborted fetus) 
If the subject has signed the pregnancy informed consent, the outcome of all pregnancies 
(spontaneous miscarriage, elective termination, normal birth or congenital abnormality) must be 
followed up and documented even if the subject was discontinued from the trial. 
12.7. 
Reporting Adverse Events 
All AEs and SAEs will be reported on the appropriate eCRF pages, which will also be the 
reporting mechanism to Elicio safety/pharmacovigilance. All AEs (related and unrelated) will be 
recorded from first dose administration until 30 days after the end of study treatment 
administration. All SAEs (related and unrelated) will be recorded from the signing of the ICF 
until 30 days after the end of study treatment administration. All SAEs must be reported to Elicio 
or their designee within 1 business day of the first awareness of the event. The investigator must 
verify the accuracy of the information recorded on the SAE pages with the corresponding source 
documents.  
Additional follow-up information, if required or available, should all be sent to Elicio or its 
designee within one business day of receipt and this should be completed on a follow-up SAE 
form, as well as documented with the original SAE source information and kept with the 
appropriate section of the subject source records.  
Elicio is responsible for notifying the relevant regulatory authorities of certain events. It is the 
PI’s responsibility to notify the Institutional Review Board (IRB) of all SAEs that occur at his or 

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her trial center in accordance with local IRB requirements. Investigators will also be notified of 
all unexpected, serious, drug-related events (Suspected Unexpected Serious Adverse Reaction 
[SUSAR] Reports) that occur during the clinical trial. Each trial center is responsible for 
notifying its IRB of these additional SAEs in accordance with local requirements. If the clinical 
site submits to a central IRB, SUSAR reports will be submitted by Elicio or its designee. 
12.8. 
Extension Protocol 
Subjects who remain in the trial until the end of the required Follow-up Period may be eligible to 
enroll in a separate Extension protocol to continue to receive further mKRAS/mNRAS lymph 
node immunotherapy to maintain effective levels of antigen-specific T-cells.  

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13. 
STATISTICS 
ELI-002-001 is a multi-center Phase 1 trial to evaluate the safety and efficacy of ELI-002 in 
subjects with mKRAS/mNRAS solid tumors who have MRD defined as a positive ctDNA blood 
test or serum tumor biomarkers persisting ≥21 days post-surgery or after last administration of 
adjuvant therapy. The investigational product ELI-002 consists of up to 2 amphiphile-modified 
KRAS peptides plus an amphiphile-modified CpG adjuvant. 
Each cohort will be evaluated separately; however, combined analysis of the RP2D and higher 
dose cohorts may be carried out to improve statistical precision via larger sample size. 
13.1. 
Sample Size 
Approximately 18 subjects are planned to enroll: 3 to 6 subjects in each of 3 cohorts. The sample 
size is not based on power calculations, but rather on clinical judgement and the expectation that 
the objectives of this trial will be met with approximately 18 subjects enrolled in the 3+3 design.  
13.2. 
General Statistical Considerations and Definitions 
13.2.1. 
General Statistical Methods 
As a general approach, continuous variables will be summarized using mean, standard deviation, 
median, minimum value, and maximum value. Categorical variables will be summarized using 
frequency counts and percentages. Time to event data will be summarized using the 
Kaplan-Meier method. Where appropriate, CIs around point estimates will be presented, and 
estimates of the median and other quantiles, as well as individual time points (for time to event 
data) will be produced.  
All statistical hypothesis testing within (for change from baseline) and between dose cohorts will 
be conducted at the 1-sided 0.05 level of significance. Nominal p-values may be computed for 
secondary or exploratory efficacy analyses as a descriptive measure of strength of results rather 
than for formal tests of hypotheses. Emphasis will be on RP2D, highest dose, and combined 
RP2D and all higher doses for change from baseline and comparison to lowest dose. No formal 
tests of hypotheses are planned for safety analyses. 
The following methods will be used in this trial for descriptive summaries and hypothesis testing 
unless otherwise indicated: 
• Mean change from baseline. Compared to zero change and compared between dose 
levels using t-tests from repeated measures as the analysis model and/or via non-
parametric tests based on ranks, as appropriate. 
• Median time to event for a single group (non-comparative). The Kaplan-Meier 
method will be used to estimate median time to event; 2-sided CIs will use the 
method of Brookmeyer and Crowley; p-values will not be computed. 
• Hazard ratio of a time to event endpoint comparing two groups. A stratified Cox 
proportional hazards model using Efron’s method for ties will be used to estimate the 
HR and 2-sided CI; p-values will be computed using the log rank test. 

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• Time to event analysis at a fixed time point. The Kaplan-Meier method will be 
used to estimate the survival (or event-free) probability; 2-sided Cis for a single 
survival probability or for a difference of two survival probabilities will use the 
complementary log-log method; p-values will be computed using the complementary 
log-log test statistic. 
• Binary endpoint for a single group (non-comparative). The binomial parameter 
(probability of success/failure) will be estimated by the sample proportion. 2-sided 
CIs will use the method of Clopper and Pearson; p-values will not be computed. 
• Comparison of binary endpoint between two groups. Difference of sample 
proportions will be used to estimate the difference in binomial parameters. 2-sided 
CIs will use Newcombe’s score method without continuity correction; p-values will 
be computed using stratified Cochran-Mantel-Haenszel test. 
All descriptive statistical analyses will be performed using SAS statistical software (Version 9.3 
or later), unless otherwise noted. Medical History and AEs will be coding using MedDRA. 
No adjustment for multiple testing will be made. 
13.2.2. 
Analysis Population 
The following populations will be used for data analyses and presentations. 
13.2.2.1. Full Analysis Set (FAS) 
The Full Analysis Set (FAS) will include all subjects who received any amount of ELI-002 
vaccine. This population will be used for summaries of subject demographics, and baseline 
characteristics. Additional exploratory analyses may be performed for the subjects treated at the 
MTD and doses lower than the MTD at which biomarker (ctDNA, or if ctDNA was not detected 
at baseline, serum tumor biomarker) clearance/reduction is observed. 
13.2.2.2. Safety Analysis Set 
The FAS will be used for the safety evaluation (AEs, clinical laboratory assessments, vital signs, 
ECGs, ECOG, PEs). No data will be imputed for the safety analysis set; only observed data will 
be summarized. 
13.2.2.3. Disease Response Evaluable Set 
All subjects who received any amount of ELI-002 vaccine who have positive MRD at baseline, 
and either:  
1. Have at least 1 available post-baseline MRD assessment, or  
2. Have experienced an RFS event (recurrence or death).  
This population will be used for supportive analysis of biomarker clearance/reduction and 
duration of biomarker clearance/reduction. 

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13.2.2.4. Per Protocol Set 
The Per Protocol Analysis Set will include all FAS subjects who have no major protocol 
violations. The exclusion list for this set will be identified prior to database lock. 
13.2.2.5. PD/Biomarker Evaluable Set 
All Phase 1 subjects who receive any amount of trial treatment, with the additional requirement 
that relevant blood sampling data at the appropriate assessment time point(s) must be available 
for inclusion in the analysis for the corresponding parameter. 
13.2.3. 
Missing Data 
There will be no substitutions made to accommodate missing data points unless specifically 
indicated otherwise. All data recorded on the CRF will be included in data listings that will 
accompany the clinical trial report. 
13.3. 
Statistical Analyses 
13.3.1. 
Demographic and Background Characteristics 
Demographic and other baseline data, including but not limited to age, sex, race, ethnicity, 
height, weight, baseline ECOG Performance Status, primary diagnosis, disease stage at diagnosis 
and screening, and prior therapies (including systemic therapies, radiation, and surgeries, etc.) 
will be listed individually by subject and summarized by trial phase and treatment group using 
descriptive statistics (continuous data) or contingency tables (categorical data). The FAS will be 
used. 
13.3.2. 
Immunogenicity Analysis 
A positive immune response for each KRAS/NRAS peptide will be determined, for example, 
using a non-parametric distribution-free resampling method for the Fluorospot assay. For all 
immunogenicity assays, cellular immune responses to ELI-002 will be summarized for each 
patient by magnitude of response and fold-change from baseline for each timepoint tested. 
Immune responses will be summarized for each tumor type and dose level cohort. 
Statistical tests such as Wilcoxon rank-sum test will be used to compare magnitude of response 
or changes before and after vaccination when applicable. The p-values associated with these tests 
will not be used for hypothesis testing. 
13.3.3. 
Efficacy Analysis 
13.3.3.1. Relapse-free survival 
Relapse-free survival will be censored on the date of the last evaluable CT scan on trial for 
subjects who do not have recurrence and who do not die while on trial. Subjects without any post 
baseline CT scans will have their RFS time censored on the date of randomization. Subjects who 
withdraw from the trial (including withdrawal of consent and lost to follow-up) will be censored 
at the last of the last CT scan. For disease recurrence documented by CT between scheduled 
evaluations, the actual date of the scan will be used. For death or recurrence after no more than 

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1 missed evaluation, the date of the event will be the date of recurrence or death, whichever 
occurs first. For death or recurrence after more than 1 missed evaluation, RFS will be censored at 
the last evaluable disease assessment.  
RFS (in months) is calculated as: 
• [(date of recurrence/death – date of randomization) + 1)]/30.4375 
13.3.3.2. Analysis of Biomarker Response 
Response will be defined as any subject with a reduction or clearance of biomarker (ctDNA or 
serum tumor biomarker) compared with baseline [Tie et al, 2019]. Subjects who do not attain a 
response for any reason (eg, missing data due to withdrawal) will be counted as non-responders. 
The subset of subjects with biomarker clearance will also be summarized.  
13.3.3.3. Analysis of Duration of Biomarker Response 
Duration of biomarker response (ie, reduction or clearance) will be reported for subjects who 
meet the biomarker reduction or clearance definitions.  
• Duration of biomarker reduction is calculated from the date of the first biomarker 
blood test with a reduction compared to baseline, until the earliest date of any of the 
following events: (1) subsequent increase in biomarker; (2) subsequent disease 
recurrence; or (3) death due to any cause.  
• Duration of biomarker clearance is calculated from the date of the first negative 
ctDNA test or the date when the serum tumor biomarker is ≤ULN to the earliest date 
of any of the following events: (1) subsequent positive ctDNA test or subsequent 
serum tumor biomarker >ULN; (2) subsequent disease recurrence; or (3) death due to 
any cause.  
If a subject has not experienced any of the events for reduction or clearance, duration of response 
will be censored on the date of the last biomarker assessment. 
Response duration will be summarized for each cohort. Assessment of biomarker response 
duration is considered supportive of the primary biomarker response analysis and is not 
considered part of the fixed sequence testing procedure to control overall type 1 error. 
13.3.3.4. Analysis of 1-Year RFS 
Exploratory analysis of 1-year RFS will be reported. 
13.3.3.5. Analysis of OS 
Exploratory analysis of OS will be reported. 
OS is calculated from the day of first ELI-002 administration  to death. For subjects who are 
alive or lost to follow-up, OS is censored at the day the subject is last known alive as the last 
recorded date known alive. OS (in months) is defined as: 
• [(date of death or last known alive – date of first ELI-002 dose) + 1)]/30.4375 

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13.3.4. 
Safety Analysis 
Summary statistics (counts, percentage, mean, standard deviation, etc.) will be provided for the 
safety endpoints as appropriate. 
Treatment-emergent adverse events (TEAEs) will be listed and tabulated by system organ class, 
preferred term, maximum CTCAE grade, relationship to trial treatment, outcome, and action 
taken with trial treatment. TEAEs will be tabulated by treatment regimen and overall and 
reviewed for potential significance and clinical importance. Adverse events qualifying as serious 
will be separately listed, along with any dose interruptions and reductions. 
Significant PE findings and vital signs will be listed and summarized by treatment regimen. 
Clinical laboratory results will be presented in a listing including change from baseline and 
selected parameters will be summarized in shift tables. ECG derived data will be explored 
graphically and by summary statistics. 
13.3.5. 
Pharmacokinetics 
No pharmacokinetics analyses will be performed. 
13.3.6. 
Pharmacodynamics 
The pharmacodynamic response to ELI-002 will be assessed by evaluation of immunogenic 
responses to the vaccine. 

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14. 
DATA INTEGRITY AND QUALITY ASSURANCE 
14.1. 
Data Management and Case Report Forms 
Elicio and/or its designee will be responsible for the processing and quality control of the data. 
Data management will be performed as described in the sponsor’s and/or designee’s standard 
operating procedures (SOPs) for clinical studies and the study Data Management Plan. Adverse 
events will be coded using MedDRA and medications will be coded using the World Health 
Organization Drug Dictionary (WHO Drug).  
The handling of data, including data quality control, will comply with regulatory guidelines (ie, 
current ICH E6) and the sponsor and/or designee SOPs.  
The eCRF will be provided by the sponsor or its designee and should be completed in 
accordance with applicable study guidelines and within the timeframe specified. Each eCRF 
should be filled out completely by the investigator or designee as stated on the Delegation of 
Authority Log. All data entry in the eCRF must have corresponding source documentation 
located in the subject study records. 
All data will be stored in a validated database that is 21 CFR Part 11 compliant. The principal 
investigator is responsible for ensuring the timely completion of eCRFs. The principal 
investigator (or sub-investigator) must review, sign and date the eCRFs at the time of study 
completion to attest to the accuracy and completeness of the study data at the clinical site. 
14.2. 
Source Documentation 
Source documents are defined as documentation of the observations and activities of a clinical 
study. Source documents may include, but are not limited to, study progress notes, email 
correspondence, subject QLQs (or PROs), subject diaries, laboratory data and pathology and/or 
imaging reports. All source documents for this study will be maintained by the investigator and 
made available to the sponsor, the sponsor designee and regulatory authorities. The signed 
informed consent document and statement of consent will be maintained in the subject study 
records, and a copy of the informed consent will be provided to the subject. 
14.3. 
Study Drug Accountability 
At all times, a record of the study drug inventory and study drug accountability must be 
maintained. Inventory and accountability records must be readily available to the study monitor, 
the sponsor, and any regulatory authority. The investigator, in conjunction with the site 
pharmacy or study drug preparation lab, is responsible for ensuring accountability of all used and 
unused study drug. 
At the end of the trial, and following study monitor verification of drug accountability, Elicio or 
its designee will provide instruction for the destruction of unused study drug supplies remaining 
at the clinical site. During the conduct of the study, used vials may be destroyed on-site if Elicio 
has approved the destruction policy and only after the study monitor has verified drug 
accountability. If study drug destruction by the clinical site is approved by Elicio or its designee, 
the investigator must ensure that all study drug is destroyed in compliance with institutional 

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policy, applicable local regulations, as well as 21 CFR 312.59 and current ICH E6 guidelines 
pertaining to drug destruction. All destruction at the clinical site must be adequately documented. 
14.4. 
Laboratory Assessments 
Local laboratories will be responsible to analyze safety laboratory tests for this study. All local 
laboratory results will be captured on eCRFs. Central labs will be used for the analysis of 
pharmacodynamic and immunology assays, as well as specialty biomarkers. 
14.5. 
Trial Monitoring 
During the trial, Elicio and/or its designee will perform periodic monitoring visits to ensure that 
the protocol and ICH/GCP are being followed in the conduct of the study. Study monitoring will 
be performed in accordance with ICH/GCP, the sponsor and/or its designee’s SOPs, the study 
protocol and study plans, as well as applicable local regulations. The monitor will maintain 
current personal knowledge of the study through observation, review of study records and source 
documentation, as well as discussion on the conduct of the study with the investigator and site 
staff. The monitor will review all study source documents to ensure that the eCRFs are 
completed and accurate. 
The monitor, Elicio representatives and regulatory authorities will be given direct access to all 
study related documentation (such as medical charts/records, laboratory reports, diagnostic 
reports, study drug logs), study staff training documentation and institutional SOPs to verify 
study conduct. His verification may continue following completion of the study. It is important 
that the investigator and study staff are available during the monitoring visit and that sufficient 
time is devoted to items requiring follow-up or resolution. 
14.6. 
Protocol Deviations 
A deviation from the protocol is a departure from the procedures and/or processes approved by 
the sponsor and the IRB and agreed to by the principal investigator.  
Protocol deviations will be reported to the sponsor or its designee as they occur or are discovered 
and must be documented as appropriate in the study source record. In addition, protocol 
deviations will be reported to the IRB per the individual IRB guidelines. The monitor will 
document deviations discovered throughout the course of monitoring visits and review of the 
eCRFs. These deviations, and any necessary corrective actions, will be reviewed and discussed 
with the sponsor and the investigators as applicable. 
14.7. 
Audits and Inspections 
During and/or after the completion of the study, authorized representatives of Elicio, a regulatory 
authority, or an IRB may visit the trial center to perform audits or inspections, including source 
data verification. The purpose of an audit or inspection, which is independent from routine 
monitoring, is to systematically and independently evaluate all trial-related activities and 
documents to determine whether these activities were conducted, according to the protocol, GCP 
and current ICH guidelines, and applicable regulatory requirements.  

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The investigators accept that by endorsing the protocol signature page that the sponsor, IRB or 
regulatory authorities may conduct an inspection to verify compliance to the protocol and 
GCP/ICH guidelines. Representatives of the sponsor, IRB or regulatory authority will be 
permitted direct access to source documents. It is important that the investigator and study staff 
are available during the inspection or audit and that sufficient time is given to addressing any 
questions or items that require resolution.  
If a regulatory authority or IRB notifies the clinical site of an inspection related to the study, the 
investigator will immediately notify the sponsor. The investigator agrees to cooperate with Elicio 
or its designees, when possible, to be present at the inspection. The investigator also agrees to 
promptly provide the sponsor with copies of inspection findings. Before submitting a response to 
regulatory authorities, the investigator will give Elicio and/or its designees the opportunity to 
review the response and provide feedback.  
14.8. 
Institutional Review Board and Other Committees 
14.8.1. 
Institutional Review Board 
Federal regulations and ICH guidelines require that IRB approval be obtained prior to 
participation of human subjects in research studies. Prior to the study start, the protocol, IB, 
informed consent form (ICF) and any other relevant documents must be approved by an IRB. 
IRB approvals, and all materials approved by the IRB for this trial must be maintained by the 
investigator and made available for inspection. Copies of all IRB approvals should be forwarded 
to Elicio or its designee. 
The investigator is responsible for informing the IRB of any amendment to the protocol in 
accordance with local requirements. In addition, the IRB must approve all advertising used to 
recruit subjects for the trial. The protocol must be re-approved by the IRB upon receipt of 
amendments and annually, as local regulations require. 
The investigator is also responsible for providing the IRB with reports of any SUSAR (suspected 
unexpected serious adverse reaction) from any other site or trial conducted with ELI-002. Elicio 
or its designee will provide this information to each participating site. 
Progress reports and notifications of SUSARs will be provided to the IRB according to local 
regulations and guidelines. 
If the clinical site submits to a central IRB, Elicio or its designee will submit the protocol, 
amendments, and any required safety notifications on the site’s behalf to the central IRB. 
14.8.2. 
Safety Monitoring Committees 
The SMC will meet at least once per cohort during the study. The SMC will consist of Elicio 
clinical representatives and the recruiting site investigators and will have the authority to assess 
and recommend any dosing changes, including dose escalation to the next cohort, based on 
cumulative safety data provided for their review. 

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15. 
ETHICS 
15.1. 
Ethical Conduct of the Trial 
The trial will be performed in accordance with the protocol, legal and regulatory requirements, 
and the general principals in the Declaration of Helsinki, International Ethical Guidelines for 
Biomedical Research Involving Human Subjects, and ICH Guidelines for GCP. 
15.2. 
Written Informed Consent 
A written informed consent form in compliance with 21 CFR Part 50 will be obtained from each 
subject prior to the subject entering the study or performance of any study specific procedures. 
The investigator at each center will ensure that the IRB approved consent form is used to provide 
the subject full and adequate oral and written information about the nature, purpose, possible 
risk, the possibility of disease progression or recurrence, and benefit of the trial. Subjects must 
also be notified that they are free to discontinue from the trial at any time. The subject should be 
given the opportunity to ask questions and allowed time to consider the information provided. 
Remote/electronic consent procedures may be used following sponsor review of the process in 
the event of Covid-19 site impact.  
The investigator must maintain the signed Informed Consent Form in the subject study record, 
along with documentation of the informed consent process (ie, statement of consent). A copy of 
the signed Informed Consent Form must be given to the subject. If the ICF is revised during the 
study, the subject must sign the revised consent form. 

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16. 
DATA HANDLING AND RECORDKEEPING 
16.1. 
Retention of Records 
The investigator must maintain all documentation relating to the trial (defined as all essential 
documents in ICH/GCP) for at least a period of 2 years after the last marketing application 
approval, or if not approved 2 years following the discontinuance of the study; or in accordance 
with local requirements (if longer). If it becomes necessary for Elicio or the Regulatory 
Authority to review any documentation relating to the trial, the investigator must permit access 
to such records. 
The clinical site will provide details of storage location for all study related documentation to the 
sponsor or its designee both during and after the study. 

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17. 
PUBLICATION POLICY 
Elicio encourages publication of results obtained during the conduct of the sponsored clinical 
trial, whether or not the results are positive or negative. To ensure against inadvertent disclosure 
of confidential information or unprotected inventions, the investigator and/or institution will 
provide Elicio the proposed publication at least thirty (30) days prior to disclosure so that Elicio 
has an opportunity to review prior to the submission or other disclosure. Upon the request of 
Elicio, Institution and Investigator will remove all confidential information of sponsor other than 
study data from such proposed publication. In addition, if any patent action is required to protect 
intellectual property rights or other proprietary rights contained in any proposed publication, the 
investigator and/or institution will delay the proposed publication for an additional 60 days to 
allow sponsor to obtain such protection.  
If the site is part of a multicenter study, the first publication will be jointly authored by all 
clinical trial sites and any subsequent publications by the investigator will reference the first 
publication. Authorship will be determined by the sponsor and investigators according to the 
ethical standards concerning publication and authorship, including Section II – “Ethical 
considerations in the Conduct and Reporting of Research” of the requirements for submission to 
biomedical journals set by the International Committee of Medical Journal Editors. Subject 
identity will remain anonymous in any presentation or reporting of the trial. At least 2 sponsor 
representatives will also be included as co-authors on the first publication of the multicenter 
results to allow recognition of the sponsor’s involvement in the design, clinical operations, and 
management of the study. If a joint manuscript is not submitted within 18 months of study 
completion the investigator is free to publish separately, following all other requirements in this 
section. 

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18. 
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19. 
APPENDICES 
19.1. 
ECOG Performance Status Scale 
The ECOG Performance Status Scale is provided in Table 24. 
Table 24: 
ECOG Performance Status Scale 
GRADE 
ECOG PERFORMANCE STATUS 
0 
Normal activity. Fully active, able to carry on all pre-disease performance without restriction. 
1 
Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able 
to carry out work of a light or sedentary nature (eg, light housework, office work). 
2 
In bed <50% of the time. Ambulatory and capable of all self-care, but unable to carry out any 
work activities. Up and about more than 50% of waking hours. 
3 
In bed >50% of the time. Capable of only limited self-care, confined to bed or chair more than 
50% of waking hours. 
4 
100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined to bed or 
chair. 
5 
Dead 
 
CRS/ICANS Consensus Criteria. Kasi PM, Dayyani F, MorrisVK, et al. Tumor-Informed 
Assessment of Molecular Residual Disease and its Incorporation into Pratice for Patients with 
Early and Advanced Stage Colorectal Cancer (CRC-MRD Consortia). J Clin Oncol. 2020;38: 
(suppl; abstr 4108).