PDS Biotechnology reaffirms guidance for Q1 initiation of VERSATILE-003

PDS Biotechnology (PDSB) reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer in the first quarter of this year. PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug application. The window for comments from the U.S. Food and Drug Administration has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune HPV and pembrolizumab in R/M HNSCC.