IMUNON Announces 2025 ASCO Annual Meeting Oral Presentation Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer

Core Insights - IMUNON, Inc. announced positive results from its Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for advanced ovarian cancer, showing significant improvements in overall and progression-free survival [1][3][4] - The company has initiated the pivotal Phase 3 OVATION 3 Study following alignment with the FDA, focusing on newly diagnosed advanced ovarian cancer patients [2][5] Group 1: Study Results - The Phase 2 OVATION 2 Study demonstrated a median increase in overall survival (OS) of 13 months for patients treated with IMNN-001 plus standard of care (SoC) compared to SoC alone (46 months vs. 33 months) [3][8] - Patients receiving IMNN-001 in conjunction with PARP inhibitors showed a median OS not yet reached after more than five years, compared to 37 months in the control group, indicating a hazard ratio of 0.38 [3][8] - The study also reported a median 3-month increase in progression-free survival (PFS) for the intent-to-treat population (14.9 months vs. 11.9 months) with a hazard ratio of 0.79 [3][8] Group 2: Treatment Details - IMNN-001 is administered intraperitoneally at a dose of 100 mg/m weekly, combined with neoadjuvant and adjuvant chemotherapy [6][7] - The study enrolled 112 patients with newly diagnosed advanced epithelial ovarian cancer, randomized 1:1 to evaluate the safety and efficacy of IMNN-001 plus chemotherapy versus standard chemotherapy alone [6][7] Group 3: Future Directions - The Phase 3 OVATION 3 Study will include women with newly diagnosed advanced ovarian cancer (stage IIIC or IV) and will assess overall survival as the primary endpoint [5] - The study will also evaluate secondary endpoints such as surgical response score and time to second-line treatment, with a focus on patients with homologous recombination deficiency (HRD+) [5] Group 4: Company Overview - IMUNON is a clinical-stage biotechnology company developing innovative treatments using its proprietary TheraPlas technology platform, which focuses on gene-based delivery of cytokines for cancer treatment [10][11] - The company aims to leverage its technology to provide effective and durable responses for patients with difficult-to-treat conditions, including advanced ovarian cancer [10][11]