IMUNON Presents Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer at ESMO Gynaecological Cancers Congress 2025

ASCO 2025 overall survival data bolster IMNN-001’s potential in advanced ovarian cancer, supported by robust translational results at ESMO

Results from OVATION 2 Study reinforce IMNN-001 mechanism of action, producing IL-12 and key anti-cancer immune cytokines in the tumor-microenvironment post-treatment

Company currently advancing Phase 3 pivotal trial of IMNN-001, with first two sites initiated

LAWRENCEVILLE, N.J., June 18, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of 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 are being highlighted in a poster presentation at the ESMO Gynaecological Cancers Congress 2025, taking place June 19-21, 2025, in Vienna, Austria.

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). IL-12 levels were sampled in the peritoneal fluid cavity, which is the primary tumor micro-environment. Results being presented at the ESMO Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively, demonstrating the tumor-localized effect of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile.

“We are encouraged by these translational data being presented at the ESMO Gynaecological Cancers Congress 2025, which strongly complement the compelling overall survival results from the OVATION 2 trial presented at ASCO 2025,” said Douglas V. Faller, M.D., Ph.D., Chief Medical Officer of IMUNON. “The clinical outcomes, showing a robust increase in overall survival for women with advanced ovarian cancer treated with IMNN-001 plus standard-of-care chemotherapy, align with these pharmacological and immunopathological findings. These results validate that IMNN-001 induces IL-12 and its downstream anti-tumor effectors, IFN-γ and TNF-α, exclusively at the tumor site with minimal systemic exposure, supporting our ongoing Phase 3 OVATION 3 trial.”

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