Imunon(US:IMNN) Globenewswire·2025-10-30 12:00Core Insights - IMUNON, Inc. has been invited to present its ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 at the IGCS and ESMO Congress 2025, highlighting the therapy's potential in treating advanced ovarian cancer [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables gene-based delivery of therapeutic proteins [10][11] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including a Phase 2 trial [11] Clinical Trial Details - The OVATION 3 study is a pivotal Phase 3 trial evaluating the safety and efficacy of IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer patients [4][5] - The trial has shown promising results from the Phase 2 OVATION 2 study, with a median overall survival (OS) increase of 13 months and a median progression-free survival (PFS) increase of 3 months compared to standard care [5][7] - The study design includes two planned interim analyses and aims for at least 95% statistical power on the primary endpoint of overall survival [5] Treatment Mechanism - IMNN-001 utilizes an interleukin-12 (IL-12) DNA plasmid vector in a nanoparticle delivery system, promoting local production of IL-12 in the tumor microenvironment, which is crucial for inducing anticancer immunity [2][8] - The therapy has demonstrated a significant therapeutic effect, with a hazard ratio (HR) of 0.70 for OS and 0.79 for PFS compared to standard care [5] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high recurrence rate post-treatment [9] - There is a critical need for therapies that improve overall survival and reduce recurrence rates in patients diagnosed with advanced stages of the disease [9]