NEW YORK, Nov. 10, 2025 — Leads & Copy — IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company, is presenting an update today on its IMNN-001 development program for treating newly diagnosed advanced ovarian cancer. The presentation includes a review of positive data from the Phase 2 OVATION 2 Study and a minimal residual disease (MRD) study conducted with Break Through Cancer, plus updates on trial activation and patient enrollment in the ongoing Phase 3 OVATION 3 pivotal trial.
The event, held today at 8:00 a.m. ET in New York City, features presentations from ovarian cancer key opinion leaders, clinicians, statistical experts, and IMUNON executives. Investors, stakeholders, analysts, and others interested in advances in ovarian cancer treatment and women’s health are encouraged to attend in-person or virtually.
Stacy Lindborg, Ph.D., President and CEO of IMUNON, stated that IMNN-001 could represent a landmark breakthrough in treating newly diagnosed ovarian cancer when combined with standard of care chemotherapy. She noted that data indicate the immunotherapy has the potential to significantly advance treatment and improve the lives of thousands of women.
Lindborg added that no other frontline ovarian cancer treatment has demonstrated improvement in overall survival, which is the primary goal. She said the results from the Ovation 2 Study, which showed a 13-month improvement in overall survival with IMNN-001 treatment plus chemotherapy, are encouraging. She also cited the highly favorable benefit-risk profile.
Premal H. Thaker, M.D., of Washington University School of Medicine, discussed the unmet needs in ovarian cancer treatment and the promise of IMNN-001. Key data from the Phase 2 OVATION 2 clinical trial were highlighted, including:
* IMNN-001 treatment’s broad impact on cancer-fighting cytokines, effectively turning the tumor microenvironment from “cold” to “hot” by activating both innate and adaptive immune systems.
* Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
* A 13-month overall survival (OS) benefit with IMNN-001 plus standard of care (SoC) chemotherapy, considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., of the University of Texas MD Anderson Cancer Center, discussed the safety, tolerability, and translational insights from the Phase 2 MRD study of IMNN-001, emphasizing the importance of frontline therapy for achieving a cure. New translational data show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, inducing a robust response and tumor microenvironment remodeling. Data also support the highly favorable benefit-risk and tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting.
Giorgio Paulon, Ph.D., of Berry Consultants, LLC, reviewed the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He emphasized the FDA-aligned Phase 3 design, leveraging an innovative, adaptive, event-driven approach aligned with prior successful oncology trials, underpinned by conservative power assumptions, strong simulation modeling, and robust statistical properties.
Douglas V. Faller, M.D., Ph.D., of IMUNON, shared new data demonstrating that IMNN-001 shifted the balance in favor of immune stimulation and remodeled the tumor microenvironment in favor of anti-tumor responses. He noted the rapid progress of the Phase 3 trial, including expansion to additional sites and enrollment exceeding expectations.
A live webcast of the event and presentation materials are available on the “Scientific Presentations” page of the IMUNON website.
IMUNON is 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. Its lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer.
The company’s lead clinical program, IMNN-001, 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.
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.
Contacts:
Jenna Urban
CG life
jurban@cglife.com
Peter Vozzo
ICR Healthcare
443-213-0505
peter.vozzo@icrhealthcare.com
Source: IMUNON, Inc.
