IMUNON to Present Phase 2 IMNN-001 Data for New Ovarian Cancer at SITC 39th Annual Meeting

IMUNON, Inc., a clinical-stage company actively engaged in advanced development of DNA-mediated immunotherapy, has announced a significant milestone. The results from its Phase 2 OVATION 2 Study of IMNN-001, an investigational treatment for advanced ovarian cancer, have been accepted for a late-breaking presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. This event is scheduled to take place both in Houston, Texas, and virtually from November 6-10, 2024.

IMUNON is also preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of a Phase 3 pivotal study for IMNN-001. This critical Phase 3 trial is anticipated to commence in the first quarter of 2025.

The company's primary clinical program, IMNN-001, is developed using IMUNON’s proprietary TheraPlas® platform technology. It consists of an IL-12 DNA plasmid vector within a nanoparticle delivery system, which allows for cell transfection and subsequent local production and secretion of the IL-12 protein. IL-12 is known for its potent anti-cancer properties, inducing T-lymphocyte and natural killer cell proliferation and countering tumor-mediated immune suppression.

"We are thrilled to present the latest data from the Phase 2 OVATION 2 Study in a late-breaking session at SITC’s Annual Meeting," stated Stacy Lindborg, Ph.D., the president and CEO of IMUNON. Dr. Lindborg emphasized the encouraging progress shown by IMNN-001 in treating advanced ovarian cancer. The top-line data recently revealed an 11.1-month increase in median overall survival for patients treated with IMNN-001 compared to those receiving standard care, marking a 35% improvement in survival. Dr. Lindborg expressed optimism about the upcoming in-person FDA meeting to finalize the Phase 3 study design, interpreting the FDA’s willingness to meet in person as a sign of strong interest in IMNN-001’s potential.

Further details about the SITC poster presentation include the following:
- Abstract Title: Phase I/II study of Safety and Efficacy of Intraperitoneal IMNN-001 with Neoadjuvant Chemotherapy of Paclitaxel and Carboplatin in Patients Newly Diagnosed with Advanced Epithelial Ovarian Cancer
- Presenting Author: Jennifer Scalici, M.D., Adjunct Professor, Department of Gynecology & Obstetrics, Emory University School of Medicine
- Presentation Date and Time: Friday, November 8, 2024, from 12:15-1:45 p.m. and 5:30-7:00 p.m. CST
- Abstract Number: 9299

IMUNON is a biotechnology company focused on creating innovative treatments that leverage the body’s natural mechanisms to generate safe, effective, and lasting responses across a broad spectrum of diseases. The company is advancing its non-viral DNA technology through two primary modalities: TheraPlas® and PlaCCine®. TheraPlas® is tailored for coding cytokines and other therapeutic proteins for solid tumor treatments that show promise with immunological approaches. PlaCCine® is designed for the delivery of DNA-coded viral antigens to elicit a robust immune response.

IMNN-001, the company’s leading clinical program, is a DNA-based immunotherapy for treating advanced ovarian cancer. It instructs the body to produce potent cancer-fighting molecules like interleukin-12 and interferon gamma at the tumor site. IMUNON is also conducting an initial human study of its COVID-19 booster vaccine (IMNN-101). The company remains committed to leveraging these modalities to advance DNA technology and better serve patients with challenging medical conditions.