IMUNON Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer

Core Insights - IMUNON is advancing its Phase 2 OVATION 2 Study to evaluate the safety and efficacy of IMNN-001 in combination with neoadjuvant chemotherapy for patients with advanced ovarian cancer [9][6] - The study aims to inform the design of a future Phase 3 trial, focusing on primary efficacy endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) [13][17] Company Overview - IMUNON is a clinical-stage biotechnology company developing non-viral DNA-mediated immunotherapy, with a focus on innovative treatments that leverage the body's natural immune responses [3][9] - The company's lead program, IMNN-001, is a DNA-based immunotherapy designed to produce interleukin-12 and interferon gamma at the tumor site, targeting advanced ovarian cancer [15][9] Study Details - The OVATION 2 Study involved 110 patients, with treatment designed to shrink tumors before surgical removal, followed by additional chemotherapy [1][9] - Patients were randomized to receive either NACT plus IMNN-001 or standard-of-care NACT, with the IMNN-001 group receiving up to 17 doses of 100 mg/m² [1][9] Clinical Context - Epithelial ovarian cancer is a significant health concern, with approximately 22,000 new cases annually in the U.S., and a high recurrence rate of 75% in advanced stages [7][9] - The five-year survival rates for patients diagnosed with Stage III/IV disease are notably low, at 41% and 20% respectively, highlighting the need for improved therapies [7][9] Future Expectations - IMUNON anticipates reporting topline results, including hazard ratios, by the end of July 2024, following the completion of data analysis by independent statisticians [9][17] - The company aims to leverage the findings from the OVATION 2 Study to enhance the therapeutic potential of its plasmid DNA technology for challenging conditions [15][9]