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PRINCETON - PDS Biotechnology Corporation (NASDAQ:PDSB) has confirmed plans to commence its VERSATILE-003 Phase 3 clinical trial for a promising cancer immunotherapy within the first quarter of 2025. The trial will evaluate the efficacy of Versamune® HPV in combination with pembrolizumab for the treatment of HPV16-positive recurrent and/or metastatic head and neck squamous cell cancer (HNSCC).
The company, which specializes in developing immunotherapies to combat cancer, submitted an updated clinical protocol on November 15, 2024, and has since aligned with the U.S. Food and Drug Administration (FDA) to proceed with the trial. PDS Biotech’s approach has been granted Fast Track designation by the FDA, a status that expedites the review process for drugs intended to treat serious conditions and fill an unmet medical need.
Dr. Frank Bedu-Addo, CEO of PDS Biotech, expressed readiness for the trial’s initiation, emphasizing the potential for improved patient outcomes. The trial will utilize a recently validated companion diagnostic to identify HPV16-positive HNSCC, marking the first time such a diagnostic is used in a Phase 3 trial for this cancer type.
HPV16-positive HNSCC is becoming increasingly prevalent, and the need for targeted therapies is growing. PDS Biotech’s trial is particularly significant as it aims to address this urgent requirement. Dr. Kirk Shepard, PDS Biotech’s Chief Medical (TASE:PMCN) Officer, highlighted the importance of confirming HPV16 status to ensure appropriate patient selection for the trial.
The forthcoming trial follows the VERSATILE-002 Phase 2 clinical results, which provided preliminary data on the treatment’s effectiveness. Patients and investors interested in the progress of VERSATILE-003 can find more information on ClinicalTrials.gov (Identifier: NCT06790966).
This update, based on a press release statement, reaffirms PDS Biotech’s commitment to advancing its clinical program and potentially offering a new therapeutic option for individuals affected by HPV16-positive R/M HNSCC.
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