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PDS Biotech Provides Business Update and Reports Second Quarter 2024 Financial Results
PRINCETON, N.J., Aug. 13, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"PRINCETON, N.J., Aug. 13, 2024 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported financial results for the second quarter of 2024. “We are exiting the second quarter with momentum. We have aligned with the FDA on the design of the Phase 3 registrational trial of Versamune® HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (“HNSCC”),” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “This clinical trial is supported by the maturing data from our VERSATILE-002 Phase 2 trial, including encouraging survival, disease control response rates and safety data. We look forward to the presentation of updated data from the VERSATILE-002 trial at the European Society for Medical Oncology (ESMO) 2024 Congress in September.” Kirk Shepard, M.D., Chief Medical Officer stated, “As a result of the recent VERSATILE-002 trial results, we have revised the statistical endpoints of the VERSATILE-003 Phase 3 trial to provide additional robustness to our trial design. Our goal now is to work with our clinical research organization to initiate the trial of the combination, which we believe has potential as the first targeted immunotherapy for HPV16-positive HNSCC. We anticipate that future studies of PDS01ADC have the potential to provide additional clinical benefit to an effective targeted immunotherapy.” Recent Developments Announced alignment with FDA to initiate Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC. This trial will be designed to investigate the combination of Versamune® HPV + pembrolizumab compared to pembrolizumab, and this design reflects updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial.PDS Biotech has initiated preparatory activities in connection with the planned start of the Phase 3 VERSATILE-003 trial in Q4 2024. Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center (Lead Investigator), presenting updated data from the VERSATILE-002 trial evaluat...