IMUNON Enters Cooperative Research and Development Agreement with National Cancer Institute to Advance Clinical Development of IMNN-001

IMUNON partners with the National Cancer Institute to expand IMNN-001 clinical development into new tumor types while preserving key IP rights.

Rhea-AI Summary

IMUNON (IMNN) has entered a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to advance IMNN-001, its DNA-based IL-12 immunotherapy.

Under the CRADA, NCI’s Cancer Therapy Evaluation Program (CTEP), which assumes regulatory sponsorship, will support further clinical and non-clinical development of IMNN-001 within the NCI Experimental Therapeutics (NExT) Program. NCI investigators will study IMNN-001 in new solid tumor indications and combination regimens, extending work from IMUNON’s ovarian cancer program. IMUNON retains ownership of its background intellectual property and any new IP it solely generates, and it can use collaboration data for IMNN-001 research and development.

The company said this partnership leverages NCI resources and the National Clinical Trials Network to initiate additional trials in a capital-efficient manner while IMUNON continues its pivotal Phase 3 OVATION 3 trial. In a prior Phase 2 study, IMNN-001 was associated with a 14.7‑month increase in median overall survival versus chemotherapy alone (45.1 vs. 30.4 months).

Positive

• First CRADA gene-based immunotherapy selected by NCI/CTEP for partnered clinical development
• Capital-efficient trial expansion using NCI and National Clinical Trials Network infrastructure for new solid tumor indications
• Phase 2 ovarian cancer data: IMNN-001 associated with a 14.7-month increase in median overall survival (45.1 vs. 30.4 months)

Negative

• None.

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Details

Market Reaction – IMNN

-4.8% Trough in 10 min

$1.50 $1.85 Day Range

$9.40M Market Cap

Following this news, IMNN has gained 10.93%, reflecting a significant positive market reaction. Argus tracked a trough of -4.8% from its starting point during tracking. Our momentum scanner has triggered 8 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $1.68. Trading volume is exceptionally heavy at 187.5x the average, suggesting very strong buying interest.

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Market Context

On July 30, IMNN rose 3.9% after reporting faster OVATION 3 enrollment, a relevant same-program prog...

Analysis

On July 30, IMNN rose 3.9% after reporting faster OVATION 3 enrollment, a relevant same-program progression as this CRADA expands IMNN-001 development into additional solid-tumor indications and combinations.

Key Figures

Overall survival increase: 14.7 months Median overall survival: 45.1 vs. 30.4 months

Overall survival increase

14.7 months

Phase 2 OVATION 2 versus chemotherapy alone

Median overall survival

45.1 vs. 30.4 months

IMNN-001 compared with chemotherapy alone

Previous Clinical trial Reports

4 past events · Latest: Jul 30

Same Type 4 events

1. Jul 30

   Enrollment momentum

   24h Move

   +3.9%

   Phase 3 OVATION 3 enrollment exceeded planned and historical rates

2. Jul 21

   MRD clinical data

   24h Move

   -5.7%

   Phase 2 MRD data showed lower positivity and higher ctDNA clearance

3. Jun 23

   Trial continuation

   24h Move

   -1.1%

   Independent committee recommended OVATION 3 continue without modification

4. Mar 25

   Overall survival data

   24h Move

   -5.4%

   Phase 2 OVATION 2 showed a 14.7-month overall-survival increase

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

crada, regulatory sponsorship, phase 3, overall survival

4 terms

crada regulatory

"entered into a Cooperative Research and Development Agreement (CRADA)"

A CRADA (Cooperative Research and Development Agreement) is a formal partnership between a U.S. government research laboratory and a non‑government organization to work together on developing new technology or products while sharing expertise, facilities, and results. For investors, a CRADA can speed up development, lower costs and provide access to government-tested science — like a company teaming up with a well‑equipped public lab to borrow tools and know‑how, which can raise the chances of successful commercialization.

regulatory sponsorship regulatory

"CTEP who assumes regulatory sponsorship will support further clinical"

An arrangement in which an authorized third party — such as a licensed adviser, broker-dealer, or listing sponsor — formally takes responsibility for helping a company meet specific regulatory or exchange requirements and vouches to regulators that the company complies. It matters to investors because a sponsor’s involvement signals that a knowledgeable, regulated party is overseeing filings, disclosures and compliance control, much like a referee or coach helps a team follow the rules and stay eligible to play.

phase 3 medical

"currently being evaluated in IMUNON's pivotal Phase 3 OVATION 3 trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

overall survival medical

"a 14.7-month increase in median overall survival compared to chemotherapy alone"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

FAQ

What is IMNN-001 and how is it being developed?

IMNN-001 is IMUNON’s DNA-based IL-12 gene-mediated immunotherapy. It is currently being evaluated in the company’s pivotal Phase 3 OVATION 3 trial in frontline advanced ovarian cancer, following a completed Phase 2 OVATION 2 study where IMNN-001 was associated with longer median overall survival compared to chemotherapy alone.

What role will the National Cancer Institute play under the CRADA?

Under the CRADA, NCI’s Cancer Therapy Evaluation Program (CTEP) assumes regulatory sponsorship and supports further clinical and non-clinical development of IMNN-001 within the NCI Experimental Therapeutics (NExT) Program. NCI investigators will evaluate IMNN-001 in new solid tumor indications and combination regimens.

How are intellectual property rights handled in this collaboration?

IMUNON retains ownership of its background intellectual property and retains ownership of new intellectual property it solely generates under the collaboration. The company also retains the right to use data generated in the collaboration for the research and development of IMNN-001.