PDS Biotech Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer

Core Viewpoint - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational immunotherapy Versamune HPV, aimed at treating recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers [4]. - The company is advancing its lead program in advanced HPV16-positive HNSCC through pivotal clinical trials [4]. Clinical Trial Details - The VERSATILE-003 trial is a global, multi-center, randomized, controlled, and open-label Phase 3 trial designed to evaluate the safety and efficacy of Versamune HPV in combination with pembrolizumab as a first-line treatment [2]. - Approximately 350 patients will be enrolled in a 2:1 ratio between the investigational arm and the control arm receiving pembrolizumab alone [2]. - The primary endpoint of the trial is overall survival, with secondary endpoints including objective response rate, progression-free survival, disease control rate, and duration of response [2]. Leadership and Expertise - Frank Bedu-Addo, PhD, serves as the President and CEO of PDS Biotech, expressing confidence in the potential of the combination therapy to improve patient outcomes [2]. - Kirk Shepard, M.D., the Chief Medical Officer, highlighted the significance of advancing into Phase 3 for improving treatment options for patients with HPV16-positive HNSCC [3]. Product Information - Versamune HPV is an HPV-specific T cell stimulating immunotherapy that has shown potential in stimulating high levels of HPV16-specific CD8+ and CD4+ T cells [3]. - The U.S. Food and Drug Administration granted Versamune HPV Fast Track designation based on data from the previous VERSATILE-002 Phase 2 trial [3].