On September 10, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, reported it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. Under the CRADA, IMUNON and the NCI’s Cancer Therapy Evaluation Program (CTEP) who assumes regulatory sponsorship will support further clinical and non-clinical development of IMNN-001, the Company’s DNA-based IL-12 immunotherapy, under the NCI Experimental Therapeutics (NExT) Program managed by CTEP. IMNN-001 is the first gene-based immunotherapy selected by NCI/CTEP for partnered clinical development under a CRADA.
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Under the agreement, NCI investigators will evaluate IMNN-001 in new solid tumor indications and combination regimens, building on clinical data from the Company’s ongoing ovarian cancer program. IMUNON will retain ownership of its background intellectual property and will retain ownership of new intellectual property solely generated by IMUNON under the collaboration, including the right to use the data generated under the collaboration for the research and development of IMNN-001. For IMUNON, the collaboration provides an opportunity to leverage the NCI resources for generating additional clinical data for IMNN-001 in new indications.
"We believe our CRADA with NCI’s CTEP will explore the broad potential of IMNN-001 and our TheraPlas platform," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "This partnership allows us to efficiently explore new indications and combinations through the expertise of CTEP and the National Clinical Trials Network (NCTN) utilizing the centralized clinical trial infrastructure funded by NCI, while keeping our team fully focused on advancing our pivotal Phase 3 OVATION 3 study in frontline ovarian cancer as rapidly as possible."
"The mechanistic rationale for IL-12 as a multipotent immune activator extends well beyond ovarian cancer, and this collaboration gives us a capital-efficient way to initiate additional clinical trials for IMNN-001 across diverse solid tumor types and indications," said Douglas V. Faller, M.D., Ph.D., Executive Vice President and Chief Medical Officer of IMUNON.
IMNN-001 is currently being evaluated in IMUNON’s pivotal Phase 3 OVATION 3 trial in frontline advanced ovarian cancer, following encouraging results from the completed Phase 2 OVATION 2 study, in which IMNN-001 was associated with a 14.7-month increase in median overall survival compared to chemotherapy alone (45.1 vs. 30.4 months).
About IMNN-001 Immunotherapy
Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity, acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive results from the completed Phase 2 OVATION 2 Study, which assessed IMNN-001 plus neoadjuvant and adjuvant chemotherapy compared to standard-of-care chemotherapy alone in 112 patients with newly diagnosed advanced ovarian cancer. IMNN-001 is now being evaluated in the Company’s pivotal Phase 3 OVATION 3 trial, enrolling patients with newly diagnosed advanced ovarian cancer at clinical sites across the U.S.
(Press release, IMUNON, SEP 10, 2026, View Source [SID1234670730])