90020 Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 

Patent Status: PCT Application PCT/ 

US2023/085725 filed on December 22, 

2023. 

Development Stage: Clinical Phase I. 

Dated: November 8, 2024. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2024–26451 Filed 11–13–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government Owned Inventions 

Available for Licensing or 

Collaboration: Methods of Detecting 

Loss of Heterozygosity and Damaging 

Mutations in Immune-Related Genes 

Using Liquid Biopsies 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute 

(NCI), an institute of the National 

Institutes of Health (NIH), Department 

of Health and Human Services (HHS), is 

giving notice of the licensing or 

collaboration opportunities for the 

inventions listed below, which are 

owned by an agency of the U.S. 

Government and are available for 

licensing or collaboration to achieve 

expeditious commercialization of 

results of federally funded research and 

development. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to these licensing and 

collaboration opportunities should be 

directed to: Suna Gulay French, Ph.D., 

Technology Transfer Manager, NCI, 

Technology Transfer Center, Email: 

suna.gulay@nih.gov or Phone: 240–276– 

7424. 

SUPPLEMENTARY INFORMATION: The 

technology is a liquid biopsy diagnostic 

assay capable of detecting loss of 

heterozygosity (LOH) and somatic 

mutations in genes important for 

antigen processing and presentation and 

interferon-g (IFN) response pathways. 

Immunotherapy is an effective cancer 

treatment utilizing T cells to recognize 

and eliminate cancer cells. Antigen 

processing and presentation machinery 

(APM) and IFN response pathways play 

an important role for T cells to target 

cancer cells. To evade immunotherapy, 

cancer cells can develop somatic 

mutations in genes important for APM 

and IFN. 

Liquid biopsy is a non-invasive tool 

that can diagnose and monitor cancer by 

analyzing circulating tumor DNA. The 

ability to detect somatic mutations and 

predict response to immunotherapies 

using liquid biopsy would be critical to 

provide more personalized cancer 

treatment. However, currently marketed 

liquid biopsies cannot predict response 

to cellular immunotherapies. As a 

result, patients with relapsed or 

recurrent disease lose valuable time and 

resources on ineffective treatments. 

The inventors at the NCI developed a 

novel method to detect somatic 

mutations from liquid biopsy samples. 

Combined with NCI’s method to detect 

loss of heterozygosity in HLA genes— 

another mechanism for immunotherapy 

evasion—this invention allows for 

improved patient selection and noninvasive prediction of response. This 

novel precision medicine method will 

allow patient-tailored treatment by 

targeting treatment based on genetic 

mutations and prediction of 

immunotherapy response. This 

invention could potentially deliver 

better patient satisfaction, lower 

healthcare costs and better outcomes. 

This invention will be used to select 

optimal patients and monitor efficacy of 

treatments—such as TCR–T cell 

therapy. There are no liquid biopsy 

assays on the market designed as 

companion diagnostics for cellular 

immunotherapy—such as TCR–T cell 

therapy. Therefore, this technology may 

be particularly appealing to codevelopment partners who are 

developing proprietary cellular 

immunotherapies. 

This Notice is in accordance with 35 

U.S.C. 209 and 37 CFR part 404. 

NIH Reference Number: E–027–2024– 

0. 

Related Technologies: E–045–2022–0. 

Product Type: Diagnostic. 

Therapeutic Area(s): Oncology or 

Immunology. 

Potential Commercial Applications: 

• Companion diagnostic for cellular 

immunotherapies. 

• Companion diagnostic for 

monitoring the effectiveness of TCRbased immunotherapies. 

• Companion diagnostic for T cellbased immunotherapies, including 

certain immune checkpoint inhibitors. 

• Research use in labs studying and 

developing new pre-clinical therapeutic 

candidates. 

• Research use in basic research labs 

studying immunotherapy resistance 

mechanisms, antigen processing and 

presentation, IFN response pathways, 

mutations in cancer cells, basic 

immunology and basic oncology. 

Competitive Advantages 

• First method to predict response to 

immunotherapies by detecting 

damaging mutations using liquid biopsy 

samples. 

• Non-invasive test not requiring 

surgery. 

• Easy to administer. 

• Allows patient-tailored treatment 

and monitor the effectiveness of TCRbased immunotherapies in a simple and 

cost-effective manner. 

• Potential improvement in patient 

survival. 

• Potential time and money savings 

for patients, physicians and hospitals. 

Patent Status: US Provisional 

Application 63/572,760 filed on April 4, 

2024. 

Development Stage: Prototype. 

Dated: November 8, 2024. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2024–26446 Filed 11–13–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Integrative Health; Amended Notice of 

Meeting 

Notice is hereby given of a change in 

the meeting of the National Advisory 

Council for Complementary and 

Integrative Health, January 24, 2025, 

10:00 a.m. to January 24, 2025, 4:00 

p.m., National Institutes of Health, DEM 

2, 6707 Democracy Boulevard, 

Bethesda, MD, 20892 which was 

published in the Federal Register on 

September 25, 2024, 89 FR 78318. 

The notice is being amended to 

change the start and end times of the 

open session portion of the meeting. 

The open session start time has changed 

from 12:30 p.m. to 1:00 p.m. and the 

end time has changed from 4:00 p.m. to 

5:00 p.m. This meeting is partially 

closed to the public. 

Dated: November 8, 2024. 

David W Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–26527 Filed 11–13–24; 8:45 am] 

BILLING CODE 4140–01–P 


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