Imunon: OVATION 2 study results reinforce IMNN-001 efficacy benefits

Imunon (IMNN) announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-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 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 plus standard-of-care neoadjuvant and adjuvant chemotherapy. IMUNON reviewed translational data on the changes induced by the local administration of IL-12 and its downstream effectors in the tumor micro-environment from paired samples 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 cells, CD8+/IDO+ cells, and CD8+/CD4+ cells. TME shift in favor of decreased immunosuppression cells and increased immunostimulatory cells in the majority of participants post-treatment. IMNN-001 treatment creates a “hot” anti-TME by increasing the recruitment of anti-tumor CD8+ and myeloid dendritic cells in 50-80% of the paired samples and decreasing immunosuppressive markers in 65-80% of the samples. IMNN-001 continues to show a favorable safety profile. In July 2025, the company announced treatment of the first patient in the pivotal Phase 3 OVATION 3 Study and is working with trial investigators to expand clinical sites and accelerate enrollment. Four sites have been activated to date and are open for patient enrollment.