PDS Biotechnology announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration regarding next steps in its planned Phase 3 clinical trial of its Versamune based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma. PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune HPV + pembrolizumab, and the triple combination of Versamune HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination. Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 55% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on PDSB:
- PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line Recurrent or Metastatic Head and Neck Cancer
- PDS Biotech to Host Clinical Program Update Conference Call on August 1, 2024, at 8 a.m. Eastern Time
- JMP Securities healthcare analysts hold an analyst/industry conference call
- PDS Biotechnology price target lowered to $9 from $11 at B. Riley
- PDS Biotechnology provides update from ongoing VERSATILE-002 Phase 2 trial