Imunon announces results from End-of-Phase 2 meeting with FDA for IMNN-001

IMUNON (IMNN) announced the outcome of its recent End-of-Phase 2 in-person meeting with the U.S. Food and Drug Administration, FDA, supporting the advancement of its investigational interleukin-12 immunotherapy IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study. IMUNON remains on track to initiate the 500-patient Phase 3 trial in the first quarter of 2025. “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 chief executive officer 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.”