IMUNON, Inc. announced on March 24, 2025, that the U.S. Food and Drug Administration (FDA) has aligned with the protocol for its Phase 3 pivotal trial, OVATION 3, for IMNN-001. This lead candidate is in development for the treatment of women with newly diagnosed advanced ovarian cancer.
The OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) compared to standard of care NACT alone. The study will enroll approximately 500 newly diagnosed Stage III/IV ovarian cancer patients, with overall survival as the primary endpoint.
The company is currently initiating trial sites and working with investigators to begin enrolling study participants. This FDA alignment is a critical step, building on the Phase 2 OVATION 2 study data that demonstrated IMNN-001 as the first immunotherapy to achieve a clinically effective response, including overall survival benefits, in frontline ovarian cancer treatment.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.