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PDS Update
PDS Update.
About this update from Emv Capital Plc
[{"type":"text","content":"\n \n \n \n RNS: For immediate release\n \n \n \n \n NetScientific plc\n \n \n \n (\"NetScientific\" or the \"Company\")\n \n \n \n PDS Biotech Announces Plan to Initiate Phase 3 Study Evaluating PDS0101 in Combination with KEYTRUDA® in Head and Neck Cancer in 2023\n \n \n \n \n Company has completed Phase 3 manufacturing of PDS0101 for randomized, controlled, registrational trial in recurrent/metastatic HPV16-positive head and neck cancer\n \n \n \n NetScientific Plc (AIM: NSCI), the investment and commercialisation group with an international portfolio of innovative life science, sustainability and technology companies, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today 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® (pembrolizumab), Merck's anti-PD-1 therapy, in the fourth quarter of 2023.\n \n \n 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).\n \n \n In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023. VERSATILE-003 is expected to involve approximately 90-100 clinical sites globally.\n \n \n 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 (BLA). Data reported at the 2022 American Society of Clinical Oncology (ASCO) 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 repor...