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.
PDS0101 in combination with KEYTRUDA (pembrolizumab) is being studied in the VERSATILE-002 Phase 2 multicenter clinical trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer in collaboration with Merck/
Frank Bedu-Addo, Ph.D., Chief Executive Officer, said, "The HPV-associated head and neck cancer prevalence continues to rise, leaving this affected group with limited treatment options to date. Receiving this designation underscores the potential of the Versamune® platform and the need for a new therapy that may improve outcomes for those with this devastating disease."
FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
PDS Biotechnology shares are trading 11.59% higher at $4.14 Thursday morning.
