Imunon presents Phase 2 ovarian cancer survival data at R&D day

Imunon Inc., a company listed on the NASDAQ under the ticker IMNN, recently unveiled promising data from its Phase 2 OVATION 2 study, aimed at treating newly diagnosed advanced ovarian cancer. The randomized trial involved 112 patients who received IMNN-001, an immunotherapy treatment, alongside standard chemotherapy versus those who received standard chemotherapy alone.

The results indicated a significantly longer median overall survival of 45.1 months for the IMNN-001 group compared to 30.4 months for the control group, showcasing an improved median survival of 14.7 months.

This advancement followed an earlier report from July 2024, which had noted a 11.1-month difference. The study's subgroup receiving PARP inhibitor maintenance therapy exhibited even more promising outcomes, with a median overall survival of 65.6 months compared to 41.4 months, marking a remarkable 24.2-month increase. IMNN-001, an IL-12 DNA plasmid administered intraperitoneally, is designed to stimulate the production of IL-12 directly in the peritoneal cavity, aiming to enhance the immune response against cancer cells.

Unlike previous IL-12 programs, IMNN-001 did not induce cytokine release syndrome or severe systemic immune-related adverse events, streamlining its safety profile.

Minor side effects included gastrointestinal issues and abdominal pain in some participants. Concurrently, preliminary data from a Phase 2 minimal residual disease study conducted in collaboration with Break Through Cancer and MD Anderson Cancer Center revealed that 44.4% of patients in the IMNN-001 group maintained detectable residual disease versus 66.7% in the control group, suggesting a 22.3% reduction in residual disease.

Additionally, circulating tumor DNA clearance was notably higher with IMNN-001 at 87.5% compared to 62.5% in the control group.

Imunon's Phase 3 OVATION 3 trial, currently enrolling around 500 patients with newly diagnosed advanced ovarian cancer, aims to evaluate the treatment's efficacy over a broader patient population, with overall survival as the primary endpoint. The trial includes two planned interim analyses, targeting completion of enrollment by the first quarter of 2029.

Independent data monitoring committees have given the green light to continue both the OVATION 3 trial and the minimal residual disease study without modifications, signaling further confidence in the research.