PDS announces submission of Phase 3 protocol to FDA to initiate VERSATILE-003

PDS Biotechnology (PDSB) announced the submission to the U.S. Food and Drug Administration, FDA, of an updated Chemistry, Manufacturing and Controls, CMC, package and a Phase 3 multicenter registrational protocol to the company’s Investigational New Drug, IND, submission to evaluate the combination of PDS0101 and KEYTRUDA, Merck’s (MRK) anti-PD-1 therapy, for the treatment of recurrent or metastatic human papillomavirus 16-positive head and neck squamous cell carcinoma, HNSCC. The protocol was developed in accordance with guidance from the FDA on key elements of the Phase 3 program to support the eventual submission of a Biologics License Application. The Phase 3 trial, named VERSATILE-003, is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA compared to KEYTRUDA monotherapy in immune checkpoint inhibitor-naive patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003, per the protocol, is overall survival. PDS Biotech anticipates initiating the VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.