Business
PDS Biotech: Submission of Phase 3 Protocol to FDA
PDS Biotech: Submission of Phase 3 Protocol to FDA.
About this update from Emv Capital Plc
[{"type":"text","content":"\n\nRNS: For immediate release\nNetScientific plc\nPDS Biotechnology Announces Submission of Phase 3 Protocol to FDA to Initiate VERSATILE-003 Trial\nVERSATILE-003 will evaluate PDS0101 in combination with KEYTRUDA® in recurrent or metastatic HPV16-positive head and neck cancer\nPDS Biotech anticipates initiating the VERSATILE-003 trial in the fourth quarter of 2023\nNetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment group, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on its proprietary T cell activating platforms, has announced the submission to the U.S. Food and Drug Administration (FDA) of an updated Chemistry, Manufacturing and Controls (CMC) package and a Phase 3 multicenter registrational protocol to the company's Investigational New Drug (IND) submission to evaluate the combination of PDS0101 and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of recurrent or metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). The protocol was developed in accordance with guidance from the FDA on key elements of the Phase 3 program to support the eventual submission of a Biologics License Application (BLA).\nThe Phase 3 trial, named VERSATILE-003, is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in immune checkpoint inhibitor (ICI)-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003, per the protocol, is overall survival (OS). The Phase 3 study is expected to involve approximately 90-100 clinical sites globally. PDS Biotech anticipates initiating the VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.\nDr Ilian Iliev, CEO of NetScientific, commented:\n\"We congratulate PDS Biotech on reaching this significant milestone and look forward to seeing the initiation in Q4 2023 of this important Phase 3 trial, VERSATILE-003.\"\nDr Lauren V. Wood, PDS Biotech's Chief Medical Officer, said:\n\"Submission of the protocol and supportive CMC documents for this Phase 3 reg...