New Jersey-based IMUNON, Inc. (Nasdaq: IMNN) entered a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, to advance clinical development of IMNN-001, the company's IL-12 DNA plasmid-based immunotherapy. Under the agreement, NCI's Cancer Therapy Evaluation Program (CTEP) assumes regulatory sponsorship of IMNN-001 under the NCI Experimental Therapeutics (NExT) Program, while NCI investigators will evaluate the asset in new solid tumor indications and combination regimens. IMUNON said it retains ownership of its background intellectual property and any new IP solely generated by IMUNON under the collaboration, along with rights to use data generated for IMNN-001 research and development.

IMNN-001 is a non-viral IL-12 DNA plasmid vector encased in a nanoparticle delivery system, developed on IMUNON's TheraPlas platform, that enables intraperitoneal cell transfection and sustained local secretion of IL-12 protein. The asset is currently enrolling patients in the pivotal Phase III OVATION 3 trial in frontline advanced ovarian cancer. That study follows the completed Phase II OVATION 2 trial in 112 patients with newly diagnosed advanced ovarian cancer, in which IMNN-001 plus neoadjuvant and adjuvant chemotherapy was associated with a 14.7-month increase in median overall survival compared to chemotherapy alone (45.1 vs. 30.4 months).

The CRADA structure gives IMUNON access to NCI's centralized clinical trial infrastructure and the National Clinical Trials Network (NCTN) without diverting resources from the ongoing Phase III OVATION 3 study, which the company said remains its primary focus. IMUNON said it expects Phase III enrollment to complete by Q1 2029. Earlier in 2026, the company reported positive preliminary data from a Phase II minimal residual disease translational study of IMNN-001, conducted in partnership with Break Through Cancer at UT MD Anderson Cancer Center, showing lower MRD-positive rates and higher circulating tumor DNA clearance compared to control. The NCI collaboration marks a separate, parallel pathway to generate clinical data in indications outside ovarian cancer, with the NCI bearing regulatory sponsorship costs through the NExT Program. IMUNON said IMNN-001 is, according to the company, the first gene-based immunotherapy selected by NCI/CTEP for partnered clinical development under a CRADA.

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