IMUNON Recommends Continued MRD Study for IMNN-001 Immunotherapy

LAWRENCEVILLE, N.J., Sept. 22, 2026 /CourierPR/ -- The Independent Data Monitoring Committee (IDMC) overseeing IMUNON's ongoing Phase 2 minimal residual disease (MRD) translational study of IMNN-001 has recommended that the study continue without modification. The IDMC reviewed all safety data to date and identified no new safety signals, confirming the favorable safety profile of IMNN-001 as an IL-12-based immunotherapy. This recommendation follows an encouraging preliminary Phase 2 MRD data reported in July, which demonstrated evidence of deeper anti-tumor activity and immune activation.

The Phase 2 MRD study, a randomized, controlled translational study assessing minimal residual disease following treatment with standard-of-care chemotherapy and bevacizumab, with or without IMNN-001, in women with newly diagnosed advanced ovarian cancer, has now demonstrated the safety and tolerability of IMNN-001 in both combination with bevacizumab and in the maintenance setting. The study is being conducted in collaboration with Break Through Cancer and is led by investigators at The University of Texas MD Anderson Cancer Center.

The IDMC, comprised of independent medical experts in gynecologic cancers, noted no new safety concerns in the ongoing pivotal Phase 3 OVATION 3 trial. The MRD study has also achieved two important safety objectives by demonstrating the safety and tolerability of IMNN-001 both in combination with bevacizumab and in the maintenance setting.

In July 2026, the Company reported encouraging preliminary data from the MRD study, which is designed both to evaluate clinical activity and to better understand how IMNN-001 remodels the tumor immune microenvironment following frontline treatment. Among patients who reached the study's primary assessment at second-look laparoscopy, treatment with IMNN-001 was associated with:

- A lower rate of MRD positivity compared with the control arm (44% versus 67%); - Higher clearance of circulating tumor DNA (ctDNA) (87.5% versus 62.5%); - A higher proportion of patients achieving "no evidence of disease" following frontline therapy (100% versus 56%).

While preliminary and based on a limited number of patients, these findings provide encouraging evidence that IMNN-001 may drive deeper anti-tumor responses while maintaining the highly favorable safety profile consistently observed across the Company's clinical development program. These clinical findings are supported by translational analyses that demonstrated robust IL-12 expression within macrophages, activation of downstream cytokines including interferon-gamma, and evidence of both macrophage and T-cell activation, consistent with remodeling the tumor immune microenvironment from an immunologically "cold" state to one that is immunologically active, or "hot."

IMUNON, a clinical-stage biotechnology company developing DNA-mediated immunotherapies, announced the IDMC's recommendation to continue its Phase 2 MRD study without modification, providing important independent validation of the favorable safety profile observed across its clinical development program. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy being developed for the localized treatment of advanced ovarian cancer. IMNN-001 has been evaluated in multiple clinical trials, including one Phase 2 clinical trial (OVATION 2) and is currently being studied in the ongoing Phase 3 clinical trial (OVATION 3).

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S., with approximately 20,000 new cases reported annually and approximately 70% of diagnoses occurring in advanced stages III/IV. 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. IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed using the company's proprietary TheraPlas® platform technology, which 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.

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 $250 million from Mr. and Mrs. William H. Goodwin, Jr. and their family, and the estate of William Hunter Goodwin III.