IMUNON, Inc. announced on December 19, 2024, a positive outcome from its Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA). The meeting focused on the production of IMNN-001 for advanced ovarian cancer treatment.
The company achieved alignment and agreement with the FDA on key CMC topics to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologic license application (BLA) submission. The FDA agreed that IMUNON’s potency assay, which measures interferon-gamma (IFN-γ), is acceptable for both clinical and commercial release.
The FDA also concurred with IMUNON’s strategy to establish comparability of in-house produced core components of IMNN-001 with those previously manufactured by an external organization. This positive interaction validates IMUNON's internal GMP manufacturing capabilities in Huntsville, Alabama, and keeps the company on track to initiate the 500-patient Phase 3 trial in the first quarter of 2025.
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