IMNN-001 shows promise in ovarian cancer with robust translational results.

IMUNON, a clinical-stage company, presented positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based IL-12 immunotherapy, for the treatment of advanced ovarian cancer. Results showed IMNN-001 produced IL-12 and key anti-cancer immune cytokines in the tumor-microenvironment post-treatment. The data supports the potential of IMNN-001 and reinforces its mechanism of action. IMUNON is currently advancing a Phase 3 pivotal trial of IMNN-001, with the first two sites initiated.

IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, has presented encouraging translational data from its Phase 2 OVATION 2 Study of IMNN-001, an investigational gene-based interleukin-12 (IL-12) immunotherapy. The study, which was presented at the ESMO Gynaecological Cancers Congress 2025, showed that IMNN-001 effectively produced IL-12 and key anti-cancer immune cytokines in the tumor microenvironment post-treatment.

The OVATION 2 Study assessed 112 participants with newly diagnosed advanced ovarian cancer who were treated with IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). The study demonstrated significant increases in IL-12, interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α) levels in the peritoneal cavity, with increases of approximately 27-, 62-, and 36-fold, respectively. 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.

IMUNON's Chief Medical Officer, Douglas V. Faller, M.D., Ph.D., noted that the clinical outcomes align with these pharmacological and immunopathological findings, supporting the ongoing Phase 3 OVATION 3 trial. The company is currently advancing the pivotal Phase 3 trial, with the first two sites initiated in May 2025.

The results from the OVATION 2 Study reinforce IMNN-001's mechanism of action and support its potential in treating advanced ovarian cancer. IMUNON is leveraging its proprietary TheraPlas® technology platform to develop innovative treatments that harness the body's natural mechanisms to generate safe, effective, and durable responses across a broad array of human diseases.

References:
[1] https://www.streetinsider.com/Corporate+News/Imunon+%28IMNN%29+Presents+Positive+Phase+2+Translational+Data+of+IMNN-001/24950319.html
[2] https://finance.yahoo.com/news/imunon-presents-positive-phase-2-120500855.html