IMUNON Announces First Site Initiated for Pivotal Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

Company currently initiating additional trial sites and working with study investigators to enroll participants

IMNN-001 is the first and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in women with advanced ovarian cancer

Data from Phase 2 OVATION 2 Study are encouraging, with new IMNN-001 data to be highlighted in oral presentation at 2025 ASCO Annual Meeting

Excerpt from the Press Release:

LAWRENCEVILLE, N.J., May 08, 2025 (GLOBE NEWSWIRE) — IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that the first trial site has been initiated for the Company’s Phase 3 pivotal study, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer. The first trial site is Washington University School of Medicine, and IMUNON is currently initiating additional trial sites and working with investigators to begin enrolling study participants.

“This represents a significant step forward for the IMNN-001 development program as we work toward bringing patients this novel IL-12 immunotherapy, the first and only product to show meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer who have not seen changes in standard of care treatment in more than 25 years,” said Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and study-level principal investigator of the OVATION 3 trial. “It has been rewarding to be part of IMNN-001’s development for more than a decade and see the progress being made, with highly encouraging data from the Phase 2 study including in women treated with PARP inhibitors as maintenance therapy. I look forward to helping advance the OVATION 3 trial and seeing the results.”

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD), including BRCA1 or BRCA2 mutations.

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