An IDMC recommended continuing a phase 2 minimal residual disease study of IMNN-001 without modification following a favorable safety review.
The independent data monitoring committee (IDMC) overseeing an ongoing phase 2 minimal residual disease (MRD) translational study (NCT05739981) of IMNN-001 (GEN-1) in patients with newly diagnosed advanced ovarian cancer has recommended that the trial continue without modification following a review of all safety data to date.¹
The IDMC, comprising independent experts in gynecologic cancers, identified no new safety signals associated with IMNN-001 and confirmed comparable safety across both arms of the study. The MRD study has also demonstrated the safety and tolerability of IMNN-001 both in combination with bevacizumab (Avastin) and in the maintenance setting, and the latest IDMC review also identified no new safety concerns in the ongoing pivotal phase 3 OVATION-3 trial (NCT06915025) of IMNN-001 plus standard neoadjuvant and adjuvant chemotherapy in patients with newly diagnosed advanced epithelial ovarian cancer.
“The IDMC’s recommendation to continue our phase 2 MRD study without modification provides important independent validation of the favorable safety profile we have consistently observed across our clinical development program,” Stacy Lindborg, PhD, president and chief executive officer of IMUNON, stated in a news release. “Across our completed and ongoing clinical studies, we have observed no cytokine release syndrome, no systemic toxicities and no serious immune-related adverse events—an important distinction for an interleukin 12 [IL-12]–based immunotherapy. Combined with the encouraging biological and clinical activity reported from this study in July [2026], these findings further strengthen our confidence as we continue advancing our pivotal phase 3 OVATION 3 trial.”
IMNN-001 Phase 2 MRD Study: Key Preliminary Findings
The phase 2 MRD study is evaluating IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy plus bevacizumab in patients with newly diagnosed advanced ovarian cancer.1,2 Patients in the experimental arm receive IMNN-001 intraperitoneally in combination with neoadjuvant and adjuvant chemotherapy plus bevacizumab, followed by interval cytoreductive surgery and additional cycles of adjuvant chemotherapy in combination with IMNN-001.²
Patients then undergo second-look laparoscopy to assess for MRD, followed by maintenance therapy assigned according to homologous recombination deficiency status. The primary end point is the MRD-positive rate at second-look laparoscopy, with progression-free survival as a secondary end point. The study also includes serial translational analyses of tumor tissue, circulating tumor DNA (ctDNA), tumor microbiome, and intraperitoneal fluid to further assess how IMNN-001 affects the tumor immune microenvironment.
In July 2026, IMUNON reported preliminary data from the phase 2 MRD study among patients who reached the study’s primary assessment at second-look laparoscopy. At that time, 9 patients each in the control and experimental arms had reached second-look laparoscopy, out of a target accrual of 30 patients (n = 15 per arm). Treatment with IMNN-001 was associated with a lower rate of MRD positivity vs control (44% vs 67%, respectively), higher rate of ctDNA clearance (87.5% vs 62.5%, respectively), and a higher proportion of patients with no evidence of disease after first-line therapy (100% vs 56%, respectively).1,2
Notably, these findings are preliminary and based on a limited number of patients.¹ The clinical findings from this trial are bolstered by findings from translational analyses showing robust IL-12 expression within macrophages, downstream cytokine activation, and evidence of both macrophage and T-cell activation, which is consistent with the transition of the tumor immune microenvironment from an immunologically “cold” state to a “hot” state.
IMNN-001 is an IL-12 DNA plasmid vector that is encased in a nanoparticle delivery system. It was designed to enable cell transfection followed by persistent, local IL-12 secretion. IL-12 is among the most active cytokines for the induction of anticancer immunity, and acts via the induction of natural killer cell and T-lymphocyte and proliferation.
The MRD findings from the phase 2 trial build on results from the completed phase 1/2 OVATION 2 study (NCT03393884), in which IMNN-001 plus neoadjuvant and adjuvant chemotherapy was associated with a 14.7-month increase in median overall survival (OS) vs chemotherapy alone and a 24.2-month increase in median OS among patients with newly diagnosed epithelial ovarian cancer who were also treated with a PARP inhibitor as maintenance therapy.²
