LAWRENCEVILLE, N.J., July 21, 2026
IMUNON, Inc. has announced positive preliminary Phase 2 minimal residual disease (MRD) clinical data for its lead DNA-mediated immunotherapy, IMNN-001, demonstrating encouraging efficacy and a highly favorable safety profile in women with newly diagnosed advanced ovarian cancer. The translational study, conducted in collaboration with Break Through Cancer and led by researchers at The University of Texas MD Anderson Cancer Center, evaluated IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy plus bevacizumab. Early findings showed lower minimal residual disease (MRD) positivity, higher circulating tumor DNA (ctDNA) clearance, and improved rates of no evidence of disease (NED) compared with the control group. The results further support the ongoing Phase 3 OVATION 3 clinical trial and reinforce IMNN-001’s potential to overcome the historical safety limitations associated with IL-12-based immunotherapies, representing an important advancement in the frontline treatment of advanced ovarian cancer.
Phase 2 MRD Study Demonstrates Encouraging Clinical Activity
The ongoing Phase 2 MRD translational study is designed to investigate how IMNN-001 remodels the tumor immune microenvironment while reducing minimal residual disease following frontline treatment. Preliminary data showed that patients receiving IMNN-001 experienced a 44% MRD-positive rate compared with 67% in the control arm. Investigators also observed a significantly higher circulating tumor DNA (ctDNA) clearance rate of 87.5% versus 62.5%, along with a 100% no evidence of disease (NED) rate following frontline therapy compared with 56% in the control group. Researchers believe these findings indicate a deeper anti-tumor response and provide additional evidence supporting the immunotherapy’s potential to improve long-term outcomes in patients with advanced ovarian cancer. Importantly, the therapy continued to demonstrate a consistent safety and tolerability profile, with no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events reported during the study.
IMNN-001 Builds on Positive OVATION Clinical Program
The new translational findings complement previously reported results from the completed Phase 2 OVATION 2 trial, where IMNN-001 demonstrated a 14.7-month improvement in median overall survival compared with chemotherapy alone and an even greater 24.2-month survival advantage among patients receiving PARP inhibitor maintenance therapy. IMNN-001 is currently being evaluated in the pivotal Phase 3 OVATION 3 clinical trial, which is actively enrolling women with newly diagnosed advanced ovarian cancer across multiple U.S. clinical sites. Mechanistic analyses from the MRD study also showed that the therapy stimulates IL-12 expression, activates macrophages and T cells, and transforms the tumor microenvironment from an immunologically “cold” tumor into a more “hot” immune-responsive environment, potentially enhancing both innate and adaptive anti-cancer immune responses. These biological findings further strengthen the scientific rationale for continued Phase 3 development.
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Advancing DNA-Based Immunotherapy for Ovarian Cancer
IMNN-001 is developed using IMUNON’s proprietary TheraPlas® DNA delivery platform, which enables localized production of interleukin-12 (IL-12) within the tumor microenvironment to stimulate durable anti-cancer immunity while minimizing systemic toxicity. Advanced ovarian cancer remains one of the most challenging gynecologic malignancies, with approximately 70% of patients diagnosed at Stage III or IV and recurrence rates remaining exceptionally high despite surgery and chemotherapy. By targeting minimal residual disease, improving immune activation, and maintaining an encouraging safety profile, IMNN-001 has the potential to address one of the greatest unmet needs in ovarian cancer treatment. As enrollment continues in the Phase 3 OVATION 3 trial, the latest clinical and translational data provide growing evidence that DNA-mediated immunotherapy may become an important component of future frontline treatment strategies for women with advanced ovarian cancer.
Source: IMUNON Press release
