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NEW YORK - PDS Biotechnology Corporation (NASDAQ:PDSB), a company specializing in immunotherapies for cancer, has initiated a Phase 3 clinical trial named VERSATILE-003, aiming to evaluate the safety and efficacy of its immunotherapy Versamune® HPV. This global trial targets the treatment of recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
The study, which is now open for patient enrollment, marks the first Phase 3 clinical trial for this particular cancer type. Approximately 350 patients will be recruited across various centers, with two-thirds receiving the investigational combination of Versamune® HPV and pembrolizumab, and one-third receiving pembrolizumab alone. The primary measure of the trial’s success will be overall survival rates, with secondary endpoints including objective response rate and progression-free survival.
Katharine Price, M.D., from the Mayo Clinic Comprehensive Cancer Centre, will oversee the trial as Principal Investigator. PDS Biotech’s Chief Medical (TASE:BLWV) Officer, Kirk Shepard, M.D., expressed optimism about the potential benefits of the combination therapy to enhance immune response and improve clinical outcomes for patients.
Versamune® HPV has previously demonstrated its ability to stimulate robust HPV16-specific T-cell responses in patients. The U.S. Food and Drug Administration acknowledged these promising results by granting the therapy Fast Track designation, which could lead to a Priority Review of its Biologics License Application.
This announcement is based on a press release statement from EMV Capital plc, which holds a 2.3% direct holding in PDS Biotech. Investors and interested parties can find more information about the VERSATILE-003 trial on ClinicalTrials.gov using the identifier NCT06790966.
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