Clinical Progress: Aligning with FDA
PDS Biotechnology, a company at the forefront of immunotherapy innovations, has achieved a significant milestone by aligning with the U.S. Food and Drug Administration (FDA) on the design of its upcoming Phase 3 VERSATILE-003 trial. This trial focuses on patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC) and is scheduled to commence in the fourth quarter of 2024. The trial will explore the efficacy of PDS Biotech's Versamune® HPV in combination with pembrolizumab, a well-known cancer therapy, compared to pembrolizumab alone.
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