PDS Biotech Gains FDA Approval for Phase 3 HPV16-Positive Head and Neck Cancer Trial

PDS Biotechnology Corporation, a leading immunotherapy company, has announced the receipt of official minutes from its meeting with the U.S. Food and Drug Administration (FDA). The meeting centered on the next steps for their planned Phase 3 clinical trial of Versamune® based immunotherapy, aimed at treating HPV16-positive head and neck squamous cell carcinoma (HNSCC). The company will discuss the trial details in a conference call scheduled for today at 8:00 a.m. ET.

In the recent meeting with the FDA, PDS Biotech presented updated data from their VERSATILE-002 study, which combines Versamune® HPV with pembrolizumab, and another study involving a triple combination of Versamune® HPV, PDS01ADC, and bintrafusp alfa. Additionally, the company shared updated designs for their Phase 3 VERSATILE-003 trial, incorporating new statistical endpoints derived from recent survival data. They proposed adding a third arm to this study, which would include the triple combination therapy. The initial phase of the study would focus on dose optimization for PDS01ADC within the new combination.

The FDA endorsed the strategy and development of both the double and triple combination therapies. However, it requested additional safety analysis for the dose optimization phase involving PDS01ADC. To prevent delays, the FDA agreed that the dose optimization could be conducted separately and allowed the main two-arm trial, VERSATILE-003, to proceed. Notably, the Versamune® HPV and pembrolizumab combination has received Fast Track designation from the FDA.

Frank Bedu-Addo, PhD, President and CEO of PDS Biotech, expressed gratitude for the FDA's support in developing the combinations. He emphasized the promising results from the VERSATILE-002 study, which have led to revisions in the study's statistical endpoints for enhanced robustness. Bedu-Addo remains optimistic about the potential of the Versamune® HPV and pembrolizumab combination to significantly improve treatment for HPV16-positive HNSCC. Furthermore, he hinted at the potential benefits of adding PDS01ADC in future treatments.

Kirk Shepard, MD, Chief Medical Officer, added that the company has already contracted with a clinical research organization and is making progress in preparations to begin enrollment in the VERSATILE-003 Phase 3 trial. This trial will focus on first-line treatment for patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the primary endpoint. Shepard noted significant support from key opinion leaders and investigators involved in the VERSATILE-002 study. Many target sites have shown strong interest in participating in the trial.

PDS Biotechnology Corporation specializes in innovative immunotherapy, targeting the immune system to combat cancers and develop vaccines for infectious diseases. The company is gearing up to launch a pivotal clinical trial in 2024 to advance its lead program for advanced HPV16-positive head and neck squamous cell cancers. Their lead investigational immunotherapy, Versamune® HPV, is being developed both as a combination with a standard immune checkpoint inhibitor and as a part of a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, and a standard immune checkpoint inhibitor.

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