IMUNON Reports Positive Phase 2 MRD Clinical Data for IMNN-001, Demonstrating the Successful Overcoming of Historical IL-12 Safety Barriers in Frontline Ovarian Cancer
Rhea-AI Summary
IMUNON (Nasdaq: IMNN) reported preliminary Phase 2 minimal residual disease (MRD) data for its IL‑12 DNA immunotherapy IMNN-001 in newly diagnosed advanced ovarian cancer, given with neoadjuvant/adjuvant chemotherapy plus bevacizumab. At second-look laparoscopy, 9 patients per arm had been evaluated.
According to IMUNON, IMNN-001 showed a lower MRD-positive rate vs. control (44% vs. 67%), higher circulating tumor DNA clearance (87.5% vs. 62.5%), and a numerically higher rate of no evidence of disease (100% vs. 56%) following frontline therapy. No cytokine release syndrome, systemic toxicities, or serious immune-related adverse events have been observed to date.
The MRD findings complement prior Phase 2 OVATION 2 data, where IMNN-001 plus chemotherapy was associated with median overall survival of 45.1 vs. 30.4 months, and 65.6 vs. 41.4 months in patients also receiving PARP maintenance. IMNN-001 is now in the pivotal Phase 3 OVATION 3 trial in frontline ovarian cancer.
Positive
- MRD-positive rate 44% vs. 67% at SLL with IMNN-001 (preliminary, n=9/arm)
- ctDNA clearance 87.5% vs. 62.5% in IMNN-001 vs. control arm
- No evidence of disease 100% vs. 56% after frontline therapy (preliminary, n=9/arm)
- Overall survival (OVATION 2) 45.1 vs. 30.4 months with IMNN-001 plus chemotherapy
- OS with PARP maintenance 65.6 vs. 41.4 months when IMNN-001 added
- Safety no cytokine release syndrome, systemic toxicities, or serious immune-related immune events reported to date
Negative
- Interim MRD results based on only 9 patients per arm at second-look laparoscopy
- Pivotal Phase 3 OVATION 3 trial is ongoing with no Phase 3 efficacy or survival data yet disclosed
News Explained
The update adds mechanistic evidence, while IMNN-001 remains in ongoing clinical testing rather than a completed efficacy stage.
The Phase 2 MRD study has not reached its total target accrual: nine patients in each arm reached second-look laparoscopy (SLL) against a target of 30, keeping this readout preliminary while Phase 3 OVATION 3 continues. The immediate change for IMUNON is additional clinical evidence within an ongoing development program, not a completed Phase 2 result.
SLL is the study's primary assessment point for surgical minimal residual disease; its primary endpoint is the MRD-positive rate at SLL, with progression-free survival as the secondary endpoint.
The release describes IMNN-001 as an intraperitoneal DNA plasmid delivered in nanoparticles to enable persistent, local IL-12 production, with the proposed mechanism involving immune activation in tumor tissue and peritoneal fluid.
Market reaction: IMNN -5.65% on Phase 2 MRD clinical data
On the day this news was published, IMNN declined 5.65%, reflecting a notable negative market reaction. Argus tracked a peak move of +14.5% during that session. Argus tracked a trough of -19.0% from its starting point during tracking. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $445K from the company's valuation, bringing the market cap to $7.44M at that time. Trading volume was exceptionally heavy at 79.1x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 23 | Phase 3 continuation | Positive | -1.1% | Data Monitoring Committee recommended OVATION 3 continuation without modification |
| Mar 25 | Phase 2 survival data | Positive | -5.4% | Updated OVATION 2 results showed extended overall survival with IMNN-001 |
| Feb 05 | Trial prioritization update | Negative | -1.6% | Strategic reorganization reduced nonessential headcount and prioritized OVATION 3 |
| Nov 10 | Clinical progress presentation | Positive | -6.3% | R&D Day presented clinical progress and Phase 3 development updates |
| Nov 07 | R&D Day announcement | Positive | +1.0% | Company announced investigator presentations covering MRD results and Phase 3 design |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial news produced three divergent negative reactions and two aligned reactions, with an average move of -2.68%.
Key Terms
minimal residual disease medical
ctdna medical
second-look laparoscopy medical
progression-free survival medical
homologous recombination deficiency medical
cytokine release syndrome medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Preliminary data reinforces IMNN-001 immunotherapy’s potential for success in the rapidly recruiting Phase 3 OVATION 3 clinical trial
- Lower rate of minimal residual disease (MRD)
- Higher ctDNA clearance with IMNN-001 vs. control
- Highly favorable safety and tolerability profile
Study, conducted in partnership with Break Through Cancer, provides new translational data and further support for IMNN-001's unique mechanism of remodeling the tumor immune microenvironment
LAWRENCEVILLE, N.J., July 21, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced new positive preliminary data from its ongoing Phase 2 minimal residual disease (MRD) translational clinical trial of IMNN-001, conducted in combination with standard of care neoadjuvant and adjuvant chemotherapy (N/ACT) plus bevacizumab, in women with newly diagnosed advanced ovarian cancer.
This cutting-edge translational study is being conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab, a multi-institutional collaboration accelerating research in ovarian cancer. The multi-site study is led by investigators at The University of Texas (UT) MD Anderson Cancer Center, which serves as the lead clinical site. Its objectives include understanding how chemo-immunotherapy with IMNN-001 impacts ovarian cancer’s “cold” tumor microenvironment and MRD after frontline treatment.
Nine patients in each of the control and experimental arms (total target accrual of 30 patients, 15 in each arm) have reached second-look laparoscopy (SLL), the study's primary assessment point for surgical MRD. Compared to control, preliminary results show a deeper antitumor response, as demonstrated by a lower MRD-positive rate, in patients treated with IMNN-001 (
“We are encouraged by these new data points from our MRD study, which continue to build the case for IMNN-001's potential to make a meaningful difference for women with newly diagnosed advanced ovarian cancer,” said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. “These findings, together with the consistent safety profile we've now observed across multiple studies, reinforce that we have overcome the historical safety and efficacy barriers associated with the development of a novel IL-12 immunotherapy and further bolster our confidence in IMNN-001 as we continue to advance our pivotal Phase 3 OVATION 3 trial.”
“These new findings from the MRD study add an important layer of evidence to what we've observed with IMNN-001 to date,” said study principal investigator, Amir Jazaeri, M.D., professor of Gynecologic Oncology and Reproductive Medicine at UT MD Anderson. “The reduction in residual disease and the encouraging ctDNA clearance we're seeing, together with a consistent safety and tolerability profile, strongly support the continued investigation of IMNN-001's role in the frontline treatment of ovarian cancer.”
These new MRD findings build on results from the Company’s 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), and a 24.2-month increase among patients who also received PARP inhibitor maintenance therapy (65.6 vs. 41.4 months). The positive tolerability profile of IMNN-001 observed in prior studies has continued in the MRD study, including in combination with standard-of-care chemotherapy plus bevacizumab and in the maintenance setting, with no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events observed to date. 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.
Reinforcing previously published phase 2 data, new translational data from the MRD study also continue to support IMNN-001's proposed mechanism of action. IMNN-001 induces robust expression of IL-12 in macrophages within the peritoneal fluid and tumor tissue, stimulating a cascade of anti-tumor cytokines, including interferon-gamma, and resulting in potent macrophage and T cell activation. These findings are consistent with a shift in the tumor immune microenvironment from “cold” to “hot,” activating both innate and adaptive immune responses.
“We remain focused on generating a comprehensive body of evidence for IMNN-001 across our clinical program,” added Dr. Lindborg. “The MRD study, together with our Phase 2 OVATION 2 results and the ongoing pivotal Phase 3 OVATION 3 trial, continues to build a consistent picture of IMNN-001's benefit-risk profile in frontline ovarian cancer treatment.”
About the Translational Phase 2 MRD Study
The Phase 2 MRD study (NCT05739981) is evaluating IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy plus bevacizumab in women with newly diagnosed advanced ovarian cancer, conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab. Patients in the experimental arm receive IMNN-001, administered intraperitoneally, in combination with N/ACT plus bevacizumab, followed by interval cytoreductive surgery and additional cycles of adjuvant chemotherapy plus IMNN-001. Patients then undergo second-look laparoscopy (SLL) to assess for minimal residual disease, followed by maintenance therapy assigned according to homologous recombination deficiency (HRD) status. The primary endpoint of the study is MRD-positive rate at SLL; the secondary endpoint is progression-free survival (PFS). The study also includes serial translational analyses of tumor tissue, circulating tumor DNA (ctDNA), microbiome, and intraperitoneal fluid, to further characterize IMNN-001's impact on the tumor immune microenvironment.
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 neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the 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
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.
About Break Through Cancer
Founded in 2021, Break Through Cancer empowers outstanding researchers and physicians to both intercept and find cures for several of the deadliest cancers by stimulating radical collaboration among outstanding cancer research institutions, including its founding partners: Dana-Farber Cancer Institute, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Memorial Sloan Kettering Cancer Center, MIT’s Koch Institute for Integrative Cancer Research, and The University of Texas MD Anderson Cancer Center.
The Foundation is supported by a Board of Directors from the five partner institutions and a Scientific Advisory Board of U.S. cancer experts. The Foundation was launched with an extraordinary challenge pledge of
For further information, please visit the Foundation’s website at www.breakthroughcancer.org.
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 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.
Investor Contact:
Valter Pinto
KCSA Strategic Communications
212-896-1254
imunon@kcsa.com
