PDS Biotechnology(PDSB) Newsfilter·2025-02-05 13:00Core Viewpoint - PDS Biotechnology Corporation is set to initiate its VERSATILE-003 Phase 3 clinical trial for Versamune® HPV combined with pembrolizumab for treating recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer in Q1 2025 [1][2]. Group 1: Clinical Trial Details - The updated clinical protocol was submitted on November 15, 2024, and the FDA comment period has concluded, allowing the company to proceed with site activation [2]. - The trial has received Fast Track designation from the FDA, indicating a priority review process for the combination therapy [2]. - A validated companion diagnostic will be used to confirm HPV16-positive status during patient screening for the trial [2][3]. Group 2: Market Context - HPV16-positive head and neck squamous cell carcinoma is expected to become the dominant type of HNSCC in the US and EU, highlighting the need for targeted therapies [3]. - The trial represents the first investigational use of a companion diagnostic in a Phase 3 clinical trial for HNSCC, which may enhance patient selection for the treatment [3]. Group 3: Company Overview - PDS Biotechnology is focused on immunotherapy, aiming to transform how the immune system targets and kills cancers, with a lead program in advanced HPV16-positive head and neck squamous cell cancers [4]. - The lead investigational therapy, Versamune® HPV, is being developed in combination with standard immune checkpoint inhibitors and a triple combination including PDS01ADC [4].