PDS Biotechnology announces request for Type C Meeting with FDA for PDS0101

PDS Biotechnology (PDSB) announced that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month. The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The request is based on positive final results from the Company’s VERSATILE-002 trial, which showed promising median overall survival, mOS, and durable progression-free survival, PFS, in patients with CPS greater than or equal to 1. The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with significant statistical power, potentially forming the basis for accelerated approval of PDS0101. mOS will remain as the primary endpoint for full approval as originally recommended by FDA.