PDS announces adoption of protocol amendment to Phase 3 VERSATILE-003 trial

PDS Biotechnology (PDSB) announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the trial’s primary endpoint for full approval, consistent with the Company’s prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration. Following the FDA’s standard 30-day wait period since filing of the amended protocol to the Investigational New Drug Application, without objection, the Company is proceeding with the amended protocol.