PDS Biotechnology gets FDA fast track status for PDS0101

PDS Biotechnology has secured fast track designation to its PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) from the US Food and Drug Administration (FDA) for the treatment of HPV16-positive head and neck cancer that is recurrent or metastatic.

The US-based clinical-stage immunotherapy company is currently evaluating the combination of PDS0101 and KEYTRUDA in the VERSATILE-002 phase 2 clinical trial for the same indication.

PDS0101, which is the lead candidate of PDS Biotechnology, is a T cell HPV-specific immunotherapy that is subcutaneously delivered.

According to PDS Biotechnology, PDS0101 has demonstrated the potential to trigger high levels of HPV16-specific CD8+ and CD4+ T cells within patients through the activation of multiple immune pathways.

The HPV-specific T cells are known to target tumors like anal, cervical, penile, vaginal, head and neck, vulvar that result from an HPV16 infection.

Frank Bedu-Addo — PDS Biotechnology CEO said: “We are thrilled that the FDA has granted Fast Track designation for PDS0101 in combination with KEYTRUDA.

“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.”

PDS Biotechnology is also carrying out three more phase 2 studies of PDS0101. These clinical studies are in advanced HPV-associated cancers, early-stage pre-metastatic HPV-associated oropharyngeal cancer, and locally advanced cervical cancer.