Positive Results from OVATION 2 Study
Imunon, Inc. announced positive results from the Phase 2 OVATION 2 study, showing an improvement in median overall survival of 13 months compared to the standard of care in ovarian cancer patients.
Phase 3 Study Initiation
The company is on track to initiate the pivotal Phase 3 OVATION 3 study in March 2025, following supportive feedback from the FDA.
Translational Data from OVATION 2
New translational data indicates a strong dose response in IL-12 levels, with 100 mg/m^2 showing about a 20% increase compared to the previous highest dose studied, demonstrating the potential for effective treatment with a favorable safety profile.
Potential for Accelerated Approval
The company is optimistic about the potential for accelerated approval based on the strength of OVATION 2 data, particularly in subgroups such as women receiving PARP inhibitors.
Strong Safety Profile
Imunon-001 demonstrates a favorable benefit-risk profile, with no elevation of immune-related adverse events or cytokine release syndrome observed.