IMUNON Presents IMNN-001 Phase 2 Translational Data in Advanced Ovarian Cancer Demonstrating 13-Month OS Extension via Tumor Micro-Environment Shift

Results from OVATION 2 Study reinforce IMNN-001 efficacy benefits observed in the clinic and unique mechanism of action, producing key anti-cancer immune cytokines post-treatment

Pivotal Phase 3 trial of IMNN-001 underway, with four trial sites activated to date and on plan for site expansion to accelerate patient recruitment

Excerpt from the Press Release:

LAWRENCEVILLE, N.J., Sept. 22, 2025 (GLOBE NEWSWIRE) — IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on the Company’s proprietary TheraPlas^® technology platform, for the treatment of newly diagnosed advanced ovarian cancer. Results were highlighted in a presentation at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research held in Denver, Colorado.

The Phase 2 OVATION 2 Study assessed 112 participants treated with IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). IMUNON reviewed translational data on the changes induced by the local administration of IL-12 and its downstream effectors in the tumor micro-environment (TME) from paired samples (pre- and post-treatment) from study participants. Results presented at the AACR Special Conference demonstrated:

• Positive shift in the local TME to favorable immune stimulatory T cell ratios in the majority of participants treated with IMNN-001, including favorable ratios of CD8+/T regulatory (Treg) cells, CD8+/IDO+ cells, and CD8+/CD4+ cells.

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