Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 54

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 54
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001 in combination with bevacizumab in patients with advanced ovarian cancer
in the frontline, neoadjuvant clinical setting.

18

This
Phase I/II study, titled “Targeting Ovarian Cancer Minimal Residual Disease (MRD) Using Immune and DNA Repair Directed Therapies,”
is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri,
M.D., Vice Chair for Clinical Research and Director of the Gynecologic Cancer Immunotherapy Program in the Department of Gynecologic
Oncology and Reproductive Medicine at MD Anderson. Dana-Farber Cancer Institute, The Sidney Kimmel Comprehensive Cancer Center at Johns
Hopkins and Memorial Sloan Kettering Cancer Center will also be participating in the trial. In addition, The Koch Institute for Integrative
Cancer Research at the Massachusetts Institute of Technology (MIT) will provide artificial intelligence services including biomarker
and genomic analysis.

Patients
are being randomized 1:1 in a two-arm trial. In October 2023, the first patient began treatment at University of Texas MD Anderson Cancer
Center in the Phase I/II Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer. The trial’s
primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), and the secondary endpoint is PFS.
SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years
following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal
evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.

As
of March 31, 2025, fourteen patients were enrolled and treated in the study at the University of Texas MD Anderson Cancer Center and
Memorial Sloan Kettering Cancer Center. John Hopkins Medicine Sidney Kimmel Cancer Care Center has been added as a clinical site for
this study and is open to recruitment.

PLACCINE
DNA VACCINE MODALITY: IMNN-101

In
January 2021, the Company announced the filing of a provisional U.S. patent application for a novel DNA-based, investigational vaccine
for preventing or treating infections from a broad range of infectious agents including the coronavirus disease using its PLACCINE DNA
v