IMUNON (NASDAQ: IMNN) announced the results of its end-of-Phase 2 meeting with the FDA supporting investigational interleukin-12 (IL-12) immunotherapy IMNN-001 for the treatment of advanced ovarian cancer into a 500-patient Phase 3 pivotal study, on track for a first quarter 2025 launch.
Positive results from the recently completed OVATION 2 Phase 2 study demonstrated that IMNN-001 immunotherapy combined with standard-of-care (SOC) chemotherapy resulted in approximately a one-year (35%) improvement in overall survival compared to SOC alone. It was observed that treatment was well-tolerated, with no reports of cytokine release syndrome or other serious immune-related events.
“The collaborative end-of-Phase 2 meeting with the FDA represents another important milestone in our IMNN-001 clinical program, and we are very pleased that the Agency is aligned with the potential for IMNN-001 to address a significant unmet need in ovarian cancer treatment and our Phase 3 plans,” said Stacy Lindborg, Ph.D., president and CEO of IMUNON.
“We are encouraged by the robust safety and efficacy data from our Phase 2 OVATION 2 Study, including the positive survival results recently presented in a late-breaking session at the SITC Annual Meeting. IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment,” Dr. Lindborg added.
