On March 25, 2025, Imunon, Inc. (IMNN) held a conference call to discuss the finalized protocol for a Phase 3 clinical trial of IMNN-001 in patients with newly diagnosed ovarian cancer. The study will mirror the Phase 2 OVATION 2 trial that reported benefits in both progression-free and overall survival. It will initially focus on those patients who are positive for homologous recombination deficiency (HDR) positive, including BRCA1 and BRCA2 mutations. HRD positive patients will receive poly ADP-ribose polymerase (PARP) inhibitors as part of the standard of care maintenance therapy. The primary endpoint of the study is overall survival (OS), with secondary endpoints of surgical response score, chemotherapy response score, clinical response, and time to second-line treatment. Imunon previously reported that IMNN-001 plus neoadjuvant and adjuvant chemotherapy (NACT) increased median OS to 46 months vs. 33 months for standard-of-care NACT with an excellent safety profile.
