On August 1, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported that it has received the official minutes from its meeting with the U.S. Food and Drug Administration ("FDA") regarding next steps in its planned Phase 3 clinical trial of its Versamune based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma ("HNSCC") (Press release, PDS Biotechnology, AUG 1, 2024, View Source [SID1234645268]). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune HPV (formerly PDS0101) in this indication.

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PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune HPV + pembrolizumab, and the triple combination of Versamune HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination.

The FDA supported the strategy and development of the double and triple combinations. Also, 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.

"We appreciate the FDA’s support in the development of both the double and triple Versamune HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. 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. Our goal now is to investigate Versamune HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy."

Kirk Shepard, MD, Chief Medical Officer, continued, "We have contracted with a clinical research organization and 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. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial."

Conference Call Details
Date: August 1, 2024
Time: 8:00 a.m. ET
Dial-in: 1-877-704-4453 or 1-201-389-0920
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