IMUNON Enters Cooperative Research and Development Agreement with National Cancer Institute to Advance Clinical Development of IMNN-001
Collaboration with NCI's Cancer Therapy Evaluation Program (CTEP) will evaluate IMNN-001
in new indications and combination regimens
IMUNON retains ownership of its background intellectual property with an opportunity to expand its IP through this collaboration
LAWRENCEVILLE, N.J., Sept. 10, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, today announced 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.
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.
About IMUNON
IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials, including one Phase 2 clinical trial (OVATION 2), and is currently conducting a Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding expectations regarding the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Investors Contact:
Valter Pinto
KCSA Strategic Communications
212-896-1254
imunon@kcsa.com
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