Core Insights - IMUNON, Inc. has received FDA support for its Phase 3 trial strategy for the investigational interleukin-12 (IL-12) immunotherapy IMNN-001 aimed at treating advanced ovarian cancer, with plans to initiate a 500-patient trial in Q1 2025 [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 [7][8] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, which has completed Phase 2 development [8] Clinical Development - The recent End-of-Phase 2 meeting with the FDA confirmed the positive results from the Phase 2 OVATION 2 Study, which showed a 35% improvement in overall survival for patients receiving IMNN-001 in combination with standard chemotherapy compared to chemotherapy alone [3] - IMNN-001 is designed using the proprietary TheraPlas® platform, which allows for the local secretion of IL-12, a potent cytokine for inducing anticancer immunity [4][8] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases diagnosed annually in the U.S., and about 70% of these cases are advanced at diagnosis [5] - The current five-year survival rates for patients diagnosed with advanced ovarian cancer are low, highlighting the need for new therapies that can improve overall survival and reduce recurrence rates [5]
IMUNON Announces Results from its End-of-Phase 2 Meeting with the FDA for its Lead IMNN-001 Clinical Program in Advanced Ovarian Cancer