IMNN-001 - (OVATION 3)

June 23, 2026: IMUNON, Inc. (NASDAQ: IMNN) reported that the independent Data Monitoring Committee recommended continuing, without modification, the pivotal Phase 3 OVATION 3 trial of IMNN-001 plus standard-of-care neoadjuvant/adjuvant paclitaxel and carboplatin in women with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

OVATION 3’s primary endpoint is overall survival (OS) and includes two planned interim analyses intended to potentially accelerate a Biologics License Application (BLA) submission to the FDA for full approval if OS reaches statistical significance. The company said 27 patients have been enrolled to date and it is on track to enroll ~80 participants by end of Q1 2027. The Phase 3 study is described as enrolling at multiple U.S. sites and compares N/ACT + IMNN-001 vs standard N/ACT (randomized controlled design).

The release also reiterated Phase 2 OVATION 2 results (112 patients; not powered for statistical significance): median OS increased by 14.7 months (45.1 vs 30.4) with IMNN-001 vs SoC, and by 24.2 months (65.6 vs 41.4) in patients receiving IMNN-001 + SoC chemotherapy plus PARP inhibitors as maintenance, with favorable safety/tolerability.