The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PDS Biotechnology's (NASDAQ:PDSB) lead drug candidate PDS0101 in combination with KEYTRUDA (pembrolizumab) for the treatment of patients with recurrent or metastatic HPV16-positive head and neck cancer.
PDS0101 is a T cell HPV-specific immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways.
