Core Insights - IMUNON, Inc. announced the initiation of a Phase 3 pivotal trial, OVATION 3, for its DNA-mediated immunotherapy IMNN-001, which has shown meaningful overall survival benefits in advanced ovarian cancer patients during Phase 2 trials [1][2][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [10][11] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed for the localized treatment of advanced ovarian cancer [11] Phase 2 Trial Results - The Phase 2 OVATION 2 study demonstrated that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, with median overall survival increasing to 46 months, surpassing the standard-of-care by 13 months [2][3] - The study involved 112 patients and assessed the safety and efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy [7] Phase 3 Trial Details - The Phase 3 OVATION 3 trial will compare IMNN-001 plus chemotherapy against standard-of-care chemotherapy in women with newly diagnosed advanced ovarian cancer [2][3] - The primary endpoint of the trial is overall survival, with secondary endpoints including surgical response score and time to second-line treatment [2] FDA Alignment - The FDA has aligned with the protocol for the Phase 3 trial, indicating regulatory support for IMUNON's plans [1][2] Future Plans - The company is focused on rapidly enrolling study participants for the Phase 3 trial to provide a much-needed treatment option for women with advanced ovarian cancer [2][3]
IMUNON Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer