IMUNON finalizes Phase 3 OVATION 3 trial design with FDA for IMNN-001 in advanced ovarian cancer

Imunon, Inc.

FDA aligns on Phase 3 protocol for IMNN-001 plus NACT vs NACT alone in newly diagnosed advanced ovarian cancer (stage 3/4).
Primary endpoint is overall survival; secondary endpoints include surgical response, clinical response, time to second-line treatment.
Phase 2 data showed median OS of 46 months for IMNN-001+NACT vs 33 months for SoC, a 13-month improvement.
Company initiating trial sites; IMNN-001 manufactured at in-house facility in Huntsville, AL.
Conference call on March 25, 2025 at 2:00 p.m. ET to discuss Phase 3 OVATION 3 trial.

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