IMUNON Presents Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer at ESMO Gynaecological Cancers Congress 2025

Rhea-AI Summary

IMUNON presented positive Phase 2 translational data for IMNN-001, its DNA-mediated immunotherapy for advanced ovarian cancer, at ESMO Gynaecological Cancers Congress 2025. The OVATION 2 Study involving 112 participants showed that IMNN-001 (100 mg/m2) administered with standard chemotherapy induced significant increases in key anti-cancer immune cytokines: IL-12 (27-fold), IFN-γ (62-fold), and TNF-α (36-fold) in the peritoneal cavity. These results complement previously reported overall survival data at ASCO 2025, where IMNN-001 demonstrated meaningful improvements in overall survival, progression-free survival, and surgical response with a favorable safety profile. The company has initiated its pivotal Phase 3 OVATION 3 Study with two trial sites launched in May 2025.

Positive

• Strong efficacy demonstrated through significant increases in anti-cancer immune cytokines (IL-12: 27-fold, IFN-γ: 62-fold, TNF-α: 36-fold)
• Favorable safety profile reported in clinical trials
• Meaningful improvements shown in multiple key metrics: overall survival, progression-free survival, and surgical response
• Progress in clinical development with Phase 3 OVATION 3 Study initiated at two sites

Negative

• None.

Insights

Oncology Clinical Research Expert

IMUNON's IMNN-001 shows promising Phase 2 results with significant survival benefits in ovarian cancer, advancing to pivotal Phase 3 trial.

The translational data from IMUNON's Phase 2 OVATION 2 Study demonstrates compelling evidence of IMNN-001's mechanism of action in advanced ovarian cancer. The treatment significantly increased key anti-cancer immune cytokines in the tumor microenvironment, with approximately 27-fold, 62-fold, and 36-fold increases in IL-12, IFN-γ, and TNF-α levels, respectively. These substantial localized increases validate the drug's intended biological activity.

What makes these results particularly noteworthy is that they complement the overall survival data presented at ASCO 2025, which showed clinically meaningful improvements in multiple endpoints including overall survival, progression-free survival, chemotherapy response score, and surgical response. The fact that IMNN-001 induces these immune responses specifically at the tumor site with minimal systemic exposure is significant, as this targeted approach potentially maximizes efficacy while minimizing off-target side effects.

The advancement to a pivotal Phase 3 trial (OVATION 3) with sites already initiated represents a critical milestone in IMNN-001's development pathway. This DNA-mediated immunotherapy utilizes the company's proprietary TheraPlas® technology platform to deliver IL-12 locally, which appears to effectively stimulate anti-tumor immune responses in the peritoneal cavity where ovarian cancer typically spreads. The favorable safety profile mentioned further strengthens the drug's clinical potential.

For a disease with historically limited treatment options and poor outcomes for advanced cases, these data suggest IMNN-001 could potentially represent a meaningful advancement in the standard of care for newly diagnosed advanced ovarian cancer patients.

ASCO 2025 overall survival data bolster IMNN-001’s potential in advanced ovarian cancer, supported by robust translational results at ESMO

Results from OVATION 2 Study reinforce IMNN-001 mechanism of action, producing IL-12 and key anti-cancer immune cytokines in the tumor-microenvironment post-treatment

Company currently advancing Phase 3 pivotal trial of IMNN-001, with first two sites initiated

LAWRENCEVILLE, N.J., June 18, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on the Company’s proprietary TheraPlas^® technology platform, for the treatment of newly diagnosed advanced ovarian cancer. Results are being highlighted in a poster presentation at the ESMO Gynaecological Cancers Congress 2025, taking place June 19-21, 2025, in Vienna, Austria.

The Phase 2 OVATION 2 Study assessed 112 participants treated with IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). IL-12 levels were sampled in the peritoneal fluid cavity, which is the primary tumor micro-environment. Results being presented at the ESMO Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively, demonstrating the tumor-localized effect of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile.

“We are encouraged by these translational data being presented at the ESMO Gynaecological Cancers Congress 2025, which strongly complement the compelling overall survival results from the OVATION 2 trial presented at ASCO 2025,” said Douglas V. Faller, M.D., Ph.D., Chief Medical Officer of IMUNON. “The clinical outcomes, showing a robust increase in overall survival for women with advanced ovarian cancer treated with IMNN-001 plus standard-of-care chemotherapy, align with these pharmacological and immunopathological findings. These results validate that IMNN-001 induces IL-12 and its downstream anti-tumor effectors, IFN-γ and TNF-α, exclusively at the tumor site with minimal systemic exposure, supporting our ongoing Phase 3 OVATION 3 trial.”

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and in a peer-reviewed article in Gynecologic Oncology, IMUNON presented unprecedented overall survival data from the Phase 2 OVATION 2 Study. Treatment with IMNN-001 plus SoC chemotherapy in women with newly diagnosed advanced ovarian cancer demonstrated consistent, clinically meaningful improvements in overall survival, progression-free survival, chemotherapy response score, and surgical response, with a favorable safety profile. IMUNON is advancing the pivotal Phase 3 OVATION 3 Study of IMNN-001, with the first two trial sites initiated in May 2025.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

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 safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

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). 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 news 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 the timing of 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.

Contacts:

Media	Investors
Jenna Urban	Peter Vozzo
CG life	ICR Healthcare
212-253-8881	443-213-0505
jurban@cglife.com	peter.vozzo@icrhealthcare.com

FAQ

What are the key findings from IMUNON's Phase 2 OVATION 2 Study of IMNN-001?

The study showed significant increases in anti-cancer immune cytokines with IL-12 (27-fold), IFN-γ (62-fold), and TNF-α (36-fold) increases in the peritoneal cavity, along with meaningful improvements in overall survival and progression-free survival.

How is IMNN-001 administered to ovarian cancer patients?

IMNN-001 is administered intraperitoneally at 100 mg/m2 weekly, alongside standard-of-care neoadjuvant and adjuvant chemotherapy.

What is the current development stage of IMUNON's IMNN-001?

IMNN-001 is currently in Phase 3 development, with the OVATION 3 Study initiated at two trial sites in May 2025.

What is the safety profile of IMNN-001 in ovarian cancer treatment?

IMNN-001 has demonstrated a favorable safety profile in clinical trials, with localized effects at the tumor site and minimal systemic exposure.

How does IMNN-001 work in treating ovarian cancer?

IMNN-001 is a DNA-mediated immunotherapy that induces IL-12 and downstream anti-tumor effectors (IFN-γ and TNF-α) exclusively at the tumor site, using IMUNON's proprietary TheraPlas technology platform.