IMUNON (IMNN) announced the positive outcome of a Type C Chemistry, Manufacturing, and Controls, CMC, meeting with the U.S. Food and Drug Administration regarding production of IMNN-001 for the treatment of women with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek 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. IMUNON remains on track to initiate the 500-patient Phase 3 trial of IMNN-001 in the first quarter of 2025.
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