PDS Biotechnology to seek expedited approval pathway for PDS0101

PDS Biotechnology (PDSB) announced that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration, FDA, to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-002 trial and a proposed amendment to the VERSATILE-003 Phase 3 trial to reduce the number of patients, while maintaining statistical power, and to add progression free survival as an earlier primary endpoint in addition to median overall survival. If the PFS endpoint is met, it would allow for an accelerated approval submission to the FDA. While the Company’s trial amendment is undergoing review by the FDA, the VERSATILE-003 trial will be temporarily paused.