Portfolio company PDS Biotechnology Corporation (Nasdaq: PDSB) has reaffirmed its guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.
PDS Biotech is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers.
PDS Biotech submitted its updated clinical protocol on 15 November 2024, amending the Investigational New Drug (IND) application. The window for comments from the US Food and Drug Administration (FDA) 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.
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