FDA grants fast track designation to PDS0101 for head and neck cancer subset
The FDA granted fast track designation to PDS0101 for treatment of certain patients with head and neck cancer.
The designation applies to use of the agent in combination with pembrolizumab (Keytruda, Merck) by patients with recurrent or metastatic HPV16-positive disease.
PDS0101 (PDS Biotechnology Corporation) is a T-cell HPV-specific immunotherapy delivered subcutaneously.
Prior studies have demonstrated its potential to stimulate high levels of HPV16-specific CD8-positive and CD4-positive T cells by activating multiple immune pathways, according to a PDS Biotech-issued press release. These T cells have been shown to target tumors caused by HPV16 infection, such as anal, head and neck, cervical, penile, vulvar and vaginal cancers.
The open-label, multicenter phase 2 VERSATILE-002 trial is evaluating the combination of PDS0101 and pembrolizumab for patients with recurrent or metastatic HPV16-positive head and neck cancer.
“We are thrilled that the FDA has granted fast track designation for PDS0101 in combination with Keytruda,” Frank Bedu-Addo, PhD, CEO of PDS Biotech, said in the release. “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 ... need for a new therapy that may improve outcomes for those with this devastating disease.”
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