PDS Biotech Reaffirms Guidance to Initiate VERSATILE-003 Phase 3 Trial in Q1 2025

PDS Biotechnology Corp

FDA cleared amended trial design for VERSATILE-003 Phase 3 trial of Versamune HPV plus pembrolizumab in HPV16-positive R/M HNSCC.
First site initiation expected in Q1 2025; FDA comment window has passed and company on track.
Fast Track designation from FDA for the combination in recurrent/metastatic HNSCC.
Companion diagnostic to confirm HPV16-positive status will be used in patient screening.
Guidance reaffirmed on February 5, 2025 via press release and corporate presentation.

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