PDS Biotechnology (NASDAQ:PDSB) announced that it has commenced its Phase 3 trial, VERSATILE-003, to evaluate the efficacy and safety of Versamune HPV plus pembrolizumab for head and neck squamous cell carcinoma (HNSCC).
The company states the combination therapy is intended for use as a first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC.
Overall survival is the primary endpoint of the open-label, controlled global trial enrolling 350 subjects. Katherine Price, associate professor, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center Oncology, will oversee the trial as principal investigator.
In a statement, Frank Bedu-Addo, CEO and president of PDS, said, “We are thrilled to share that the first trial site has been initiated, and activation of additional clinical sites continues.”
He added, “Considering the strength and durability of the clinical responses in our VERSATILE-002 study, we are pleased to get this registrational trial underway. We are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care.”
