Core Insights - IMUNON has achieved a significant milestone by reaching data lock for the OVATION 2 Study, which evaluates the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer [2][6] - The study aims to provide insights for the design of a future Phase 3 trial, focusing on primary efficacy endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) [7][8] Group 1: Study Overview - The OVATION 2 Study is assessing the intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy for patients newly diagnosed with advanced epithelial ovarian cancer [1][6] - A total of 110 patients were fully enrolled in the study by September 2022, with a randomization of 1:1 for treatment comparison [1][6] - The study has reached a median treatment observation duration of 16 months, as required by the protocol [6] Group 2: Treatment Details - IMNN-001 is administered alongside neoadjuvant chemotherapy, with patients receiving up to 17 doses of 100 mg/m² [1][6] - The treatment strategy is designed to shrink tumors for optimal surgical removal, followed by additional cycles of adjuvant chemotherapy [1][6] Group 3: Expected Outcomes - IMUNON anticipates reporting topline results, including hazard ratios, by the end of July 2024 [6] - The primary efficacy analysis will be based on the Intent to Treat (ITT) population, with secondary endpoints including OS, Objective Response Rate, and Chemotherapy Response Score [7] Group 4: Company Background - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology [10][11] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, designed to induce the production of cancer-fighting molecules at the tumor site [11]
IMUNON Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer