IMUNON Reports Positive Phase 2 Results For IMNN-001 In Advanced Ovarian Cancer Study

IMUNON, Inc., a clinical-stage biotechnology company advancing DNA-mediated immunotherapy, has announced encouraging preliminary results from its ongoing Phase 2 minimal residual disease (MRD) translational clinical trial evaluating IMNN-001. The investigational therapy is being studied in combination with the current standard of care, including neoadjuvant and adjuvant chemotherapy (N/ACT) and bevacizumab, for women newly diagnosed with advanced ovarian cancer. The latest findings suggest that IMNN-001 may improve treatment outcomes by reducing residual disease following frontline therapy.

The study is being conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab, a multi-institutional research collaboration focused on accelerating advances in ovarian cancer treatment. Led by investigators at The University of Texas MD Anderson Cancer Center, the trial is designed to examine how IMNN-001 influences the tumor microenvironment and affects minimal residual disease after initial treatment. Researchers are particularly interested in determining whether the therapy can help transform ovarian tumors from an immune-resistant, or "cold," state into a more immune-responsive, or "hot," environment.

So far, nine patients in both the experimental and control groups have completed the study's primary assessment at second-look laparoscopy. Preliminary results showed promising improvements in patients receiving IMNN-001 compared with those receiving standard treatment alone. The IMNN-001 group demonstrated a lower rate of minimal residual disease, higher clearance of circulating tumor DNA (ctDNA), and a greater proportion of patients achieving no evidence of disease after frontline treatment. These early findings indicate that adding IMNN-001 to standard therapy may enhance the body's ability to eliminate remaining cancer cells following initial treatment.

Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON, said the latest results further strengthen the company's confidence in IMNN-001 as a potential frontline treatment for advanced ovarian cancer. She noted that the positive efficacy signals, together with the consistent safety profile observed across multiple clinical studies, suggest the company has successfully addressed many of the historical challenges associated with developing IL-12-based immunotherapies. According to her, these findings provide additional support for the ongoing Phase 3 OVATION 3 clinical trial.

Study principal investigator Amir Jazaeri, M.D., Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, also highlighted the importance of the new findings. He said the reduction in residual disease, encouraging ctDNA clearance, and continued favorable safety profile support further investigation of IMNN-001 as part of frontline treatment for ovarian cancer. The therapy has continued to demonstrate good tolerability in combination with chemotherapy and bevacizumab, with no cytokine release syndrome, major systemic toxicities, or serious immune-related adverse events reported to date.

The new MRD data also build upon the company's previously completed Phase 2 OVATION 2 study, where IMNN-001 demonstrated a meaningful improvement in median overall survival compared with chemotherapy alone. Patients treated with IMNN-001 experienced longer survival, with even greater benefits observed among those who later received PARP inhibitor maintenance therapy. In addition, translational findings from the current study continue to support the proposed mechanism of action of IMNN-001. 

The therapy stimulates the production of IL-12 within the tumor environment, activates important immune cells such as macrophages and T cells, and promotes a stronger anti-tumor immune response by converting immune-resistant tumors into more active immune environments. Together with the ongoing Phase 3 OVATION 3 trial, these findings continue to strengthen the overall evidence supporting IMNN-001 as a potential new treatment option for women with newly diagnosed advanced ovarian cancer.