LAWRENCEVILLE, N.J. — September 22, 2026

IMUNON announced that the Independent Data Monitoring Committee (IDMC) overseeing its Phase 2 minimal residual disease (MRD) study of IMNN-001 has recommended that the trial continue without modification following a review of all safety data available to date. The committee identified no new safety signals and confirmed comparable safety across the treatment arms, supporting continued evaluation of IMNN-001 in women with newly diagnosed advanced ovarian cancer. The study is being conducted with standard-of-care chemotherapy and bevacizumab, with or without IMNN-001.

Phase 2 MRD Study Evaluates IMNN-001 in Ovarian Cancer

The randomized Phase 2 MRD study is evaluating IMNN-001 in combination with standard-of-care chemotherapy and bevacizumab in women with newly diagnosed advanced ovarian cancer. The experimental arm receives intraperitoneal IMNN-001 alongside neoadjuvant and adjuvant chemotherapy plus bevacizumab, followed by interval cytoreductive surgery and additional treatment. Patients subsequently undergo second-look laparoscopy to assess minimal residual disease, with maintenance therapy assigned according to homologous recombination deficiency status. The primary endpoint is the MRD-positive rate at second-look laparoscopy, while progression-free survival is a secondary endpoint.

Preliminary Data Show MRD and ctDNA Activity

Preliminary Phase 2 data reported in July 2026 showed lower MRD positivity and higher ctDNA clearance with IMNN-001 compared with the control arm, although the findings remain preliminary and are based on a limited number of patients. Among patients reaching the primary assessment, MRD positivity was reported at 44% versus 67%, while circulating tumor DNA clearance was 87.5% versus 62.5%. The company also reported that 100% of patients receiving IMNN-001 achieved no evidence of disease following frontline therapy compared with 56% in the control arm. Translational analyses showed IL-12 expression within macrophages, downstream interferon-gamma activation and evidence of macrophage and T-cell activation. These findings are being evaluated as part of the study’s broader assessment of immune microenvironment remodeling.

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IMUNON Advances IMNN-001 Toward Phase 3

The latest IDMC review also identified no new safety concerns in the ongoing Phase 3 OVATION 3 trial, while the Phase 2 MRD study has demonstrated the tolerability of IMNN-001 both with bevacizumab and in the maintenance setting. IMNN-001 is an IL-12 DNA-based immunotherapy developed using IMUNON’s TheraPlas platform, which is designed to enable localized and sustained IL-12 production at the tumor site. The company is developing IMNN-001 for localized treatment of advanced ovarian cancer and continues to advance the program toward Phase 3 development. The MRD study is also generating translational data from tumor tissue, ctDNA, microbiome and intraperitoneal fluid to further characterize the treatment’s biological effects.

Source :IMUNON, press release