IMUNON, Inc. announced on October 30, 2024, that new clinical data from its Phase 2 OVATION 2 Study of IMNN-001 was accepted for a late-breaking presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, scheduled for November 6-10, 2024.
The company also disclosed plans to hold an in-person End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of a Phase 3 pivotal study for IMNN-001. This pivotal trial is expected to commence in the first quarter of 2025.
Topline data previously reported from the OVATION 2 Study indicated an 11.1-month increase in median overall survival among patients treated with IMNN-001, representing a 35% improvement. The acceptance for a late-breaking presentation at SITC and the planned FDA meeting underscore the significance of these results and the company's progress towards late-stage development.
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