PDS Biotech aligns with FDA on Phase 3 VERSATILE-003 trial for HPV16-positive HNSCC; initiation in Q4 2024

PDS Biotechnology Corp

Received official FDA minutes supporting Phase 3 trial of Versamune HPV + pembrolizumab for first-line recurrent/metastatic HPV16-positive HNSCC.
FDA agreed to separate PDS01ADC dose optimization to avoid delay; VERSATILE-003 proceeds as a 2-arm double combination registrational trial.
Phase 3 VERSATILE-003 trial to begin enrollment in Q4 2024; primary endpoint is overall survival.
Versamune HPV + pembrolizumab combination holds FDA Fast Track designation for this indication.
Corporate presentation updated; management cites matured VERSATILE-002 survival data supporting revised statistical endpoints.

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