IMUNON, Inc. announced on November 25, 2024, the positive outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The FDA Project Team supported the company’s proposed Phase 3 trial strategy for IMNN-001 in advanced ovarian cancer.
The FDA's alignment included the overall trial design, target patient population, treatment schedule, and primary endpoint for the pivotal study. This interaction represents a significant milestone, confirming the regulatory path forward for IMNN-001.
IMUNON remains on track to submit the final protocol in December and initiate the 500-patient Phase 3 registrational trial in the first quarter of 2025. The Phase 2 OVATION 2 Study previously demonstrated an approximate one-year (35%) improvement in overall survival with IMNN-001, alongside a favorable safety profile.
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