PDSB - Release - PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate PDS0101

FLORHAM PARK, N.J., June 02, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T cell activating technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). PDS0101 in combination with KEYTRUDA® is being studied in the VERSATILE-002 Phase 2, open-label, multicenter trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer in collaboration with Merck (known as MSD outside the US and Canada). Read More >>