Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 27

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 27
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P-ribose polymerase (PARP) inhibitors
as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical
response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several
exploratory endpoints.

22

In
March 2025, the Company announced that the FDA is aligned with the protocol for the Phase 3 OVATION 3 pivotal trial of its lead candidate
IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The Company is currently enrolling patients
at four trial sites with additional sites being considered for activation.

The Company enrolled
and treated the first patient in the pivotal Phase 3 Ovation 3 Study in July 2025 and is working with trial investigators to expand clinical
sites and accelerate enrollment.

As
of September 30, 2025, four sites are open
to recruitment, Providence Sacred Heart Medical Center & Children’s Hospital, Washington University School of Medicine in
St. Louis, Providence Cancer Institute in Portland, and Erlanger Health in Chattanooga with up to 46 additional sites being considered for activation.

IMNN-001
in Combination with bevacizumab. In February 2023, the Company and Break Through Cancer, a public foundation dedicated
to supporting translational research in the most difficult-to-treat cancers that partners with top cancer research centers, announced
the commencement of patient enrollment in a collaboration to evaluate IMNN-001 in combination with bevacizumab in patients with advanced
ovarian cancer in the frontline, neoadjuvant clinical setting.

This
Phase I/II study, titled “Targeting Ovarian Cancer Minimal Residual Disease (MRD) Using Immune and DNA Repair Directed
Therapies,” is expected to enroll up to 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