LAWRENCEVILLE, N.J. — September 10, 2026

IMUNON, Inc. announced a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to support further clinical and non-clinical development of IMNN-001, the company’s DNA-based IL-12 immunotherapy. Under the collaboration, the NCI’s Cancer Therapy Evaluation Program (CTEP) will assume regulatory sponsorship and evaluate IMNN-001 through the NCI Experimental Therapeutics (NExT) Program. The partnership will investigate the therapy in new solid tumor indications and combination regimens, building on clinical experience from IMUNON’s ovarian cancer program. IMUNON said IMNN-001 is the first gene-based immunotherapy selected by NCI/CTEP for partnered clinical development under a CRADA, highlighting the significance of the collaboration for both the company and its TheraPlas® platform. The agreement also allows IMUNON to retain ownership of its background intellectual property and certain new intellectual property generated solely by the company

NCI Collaboration Expands IMNN-001 Development Scope

The CRADA gives IMUNON access to NCI and Cancer Therapy Evaluation Program resources to explore the broader potential of localized IL-12 immunotherapy. NCI investigators will evaluate IMNN-001 across additional solid tumor types and treatment combinations, potentially expanding the clinical development scope beyond ovarian cancer. IMUNON expects the collaboration to provide additional clinical data while maintaining a capital-efficient development model, allowing the company to leverage the NCI’s clinical expertise and the centralized infrastructure of the National Clinical Trials Network (NCTN). The strategy enables IMUNON to pursue additional indications without diverting its core team from its pivotal ovarian cancer program. The company is continuing to prioritize Phase 3 OVATION 3, which is evaluating IMNN-001 in frontline advanced ovarian cancer. By combining an externally supported expansion program with its internally prioritized registrational study, IMUNON is positioning IMNN-001 for broader clinical validation while maintaining focus on its lead indication.

IMNN-001 Builds on Phase 2 Ovarian Cancer Data

IMNN-001 enters the NCI collaboration with clinical evidence from the completed Phase 2 OVATION 2 study and an ongoing pivotal Phase 3 program. OVATION 2 evaluated IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in 112 patients with newly diagnosed advanced ovarian cancer. According to IMUNON, the study demonstrated a 14.7-month increase in median overall survival, with median survival of 45.1 months for the IMNN-001 combination compared with 30.4 months for chemotherapy alone. The therapy is now being evaluated in the OVATION 3 Phase 3 trial at clinical sites across the United States. IMNN-001 uses the company’s TheraPlas platform to deliver an IL-12 DNA plasmid through a nanoparticle system, enabling cellular transfection and persistent local secretion of IL-12 at the tumor site. IL-12 is intended to stimulate anticancer immunity through activation and proliferation of T lymphocytes and natural killer cells, providing the biological foundation for testing the therapy across additional tumor types.

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IMUNON Expands DNA Immunotherapy Platform

The NCI partnership strengthens IMUNON’s broader strategy of developing non-viral DNA technologies for cancer and other diseases. The company’s TheraPlas platform is designed to deliver genes encoding cytokines and other therapeutic proteins directly to target tissues, while its separate PlaCCine® platform focuses on gene delivery of viral antigens for vaccine applications. The CRADA provides an opportunity to test whether the TheraPlas-based IMNN-001 approach can generate therapeutic activity beyond its current ovarian cancer focus. For IMUNON, retaining relevant intellectual property rights while accessing NCI clinical infrastructure creates an attractive framework for expanding the program. The collaboration also separates the expansion of IMNN-001 into new indications from the company’s core Phase 3 execution, allowing IMUNON to remain focused on OVATION 3 while NCI-supported studies investigate additional opportunities. With regulatory sponsorship from CTEP and new clinical programs under consideration, IMUNON is positioning IMNN-001 as a broader DNA-mediated immunotherapy platform candidate across solid tumors..

Source:IMUNON press release