PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line Recurrent or Metastatic Head and Neck Cancer

NetScientific's portfolio company, PDS Biotechnology Corporation, has received official minutes from its meeting with the U.S. Food and Drug Administration (FDA) regarding the next steps in its planned Phase 3 clinical trial of its Versamune® based investigational immunotherapy for HPV16-positive head and neck squamous cell carcinoma (HNSCC). The FDA supported the strategy and development of the double and triple combinations, and the company is pleased to have aligned on initiating the updated VERSATILE-003 study. The VERSATILE-002 results have matured significantly and positively over the last year, allowing the company to revise the statistical endpoints of the study to provide additional robustness to the study design.

PDS Biotech proposed the addition of a third arm to the study, which would be a triple combination of Versamune® HPV + PDS01ADC + pembrolizumab. The FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately, and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune® HPV + pembrolizumab combination has received Fast Track designation.

Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, expressed appreciation for the FDA's support and stated, "We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC." Kirk Shepard, MD, Chief Medical Officer, mentioned that the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study's primary endpoint.

NetScientific plc is a deep tech and life sciences VC investment group with an international portfolio of innovative companies. The company adds value through the proactive management of its portfolio, progressing to key value inflection points, and delivering investment returns through partial or full liquidity events. PDS Biotechnology, a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, is one of the companies in NetScientific's portfolio.