IMNN-001 - (OVATION 3)

July 30, 2026: IMUNON, Inc. (NASDAQ: IMNN) provided a progress update on its pivotal Phase 3 OVATION 3 trial evaluating intraperitoneal IMNN-001 (100 mg/m²) plus standard neoadjuvant/adjuvant chemotherapy versus chemotherapy alone in newly diagnosed advanced epithelial ovarian cancer. The company said site activation and enrollment are exceeding forecasts, with an observed enrollment rate of ~0.5 patients/site/month versus 0.3 assumed in the trial plan (and ~0.2 typical for historical ovarian cancer trials). IMUNON now projects completing enrollment in Q2 2029.

Two pre-planned interim analyses are expected; the company stated the goal is an early BLA filing for full regulatory approval if pre-specified thresholds are met.

Safety/tolerability remains favorable: no observed cytokine release syndrome, systemic toxicities, or serious immune-related adverse events; safety was comparable between arms, and recent Independent Data Monitoring Committee reviews of OVATION 3 and an ongoing Phase 2 Minimal Residual Disease study raised no safety issues.

Trial endpoints: primary endpoint overall survival; secondary endpoints include chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate.