PDS Biotechnology announces plan to initiate Phase 3 study evaluating PDS0101

PDS Biotechnology announced that it has completed key tech transfer, scale up and manufacturing activities required to initiate a global, multicenter Phase 3 registrational trial investigating the combination of PDS0101 and KEYTRUDA, Merck’s (MRK) anti-PD-1 therapy, in the fourth quarter of 2023. The Phase 3 trial, named VERSATILE-003, will investigate the combination compared to KEYTRUDA monotherapy for the treatment of unresectable, recurrent/metastatic human papillomavirus, HPV, 16-positive head and neck squamous cell carcinoma, HNSCC. In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug application to the U.S. Food and Drug Administration in the third quarter of 2023. VERSATILE-003 is expected to involve approximately 90-100 clinical sites globally. PDS Biotech’s plan to initiate the VERSATILE-003 trial follows the successful completion of an End-of-Phase 2 meeting in the third quarter of last year with the FDA, during which PDS Biotech received guidance from the FDA on key elements of the Phase 3 program that will support the submission of a Biologics License Application. Data reported at the 2022 American Society of Clinical Oncology Annual Meeting indicated the combination of PDS0101 and KEYTRUDA achieved an objective response rate of 41% and an overall survival rate of 87% at nine months in 17 evaluable patients with HPV16 and PD-L1 positive recurrent or metastatic HNSCC. Safety data reported on the first 43 patients enrolled in the trial suggested that the combination was well tolerated with no treatment-related Grade 3 or 4 Adverse Events. Based on these data, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA for the treatment of HPV16-positive HNSCC.