Business
Replacement RNS: PDS Biotech Aligns with FDA
Replacement RNS: PDS Biotech Aligns with FDA.
About this update from Emv Capital Plc
[{"type":"text","content":"\n\nImmediate release\n \nNetScientific plc\n \nReplacement RNS: PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line Recurrent or Metastatic Head and Neck Cancer\n \nThe following amendment has been made to the \"PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line Recurrent or Metastatic Head and Neck Cancer\" released on 2 August at 07:00 under RNS number 8959Y.\n \nThe following two sub-headings have been removed:\n \n· Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line Recurrent or Metastatic Head and Neck Cancer\n \n· Expanded Global Intellectual Property Surrounding Versamune® Platform\n \nThe following sub-heading has been added:\n \n· Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024\n \nThe full amened text is shown below.\n \n___________________________________\n \nCompany to initiate Phase 3 VERSATILE-003 trial in Q4 2024\n \nNetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment group, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), in which it holds a 3% direct holding, has announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration (\"FDA\") regarding next steps in its planned Phase 3 clinical trial of its Versamune® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (\"HNSCC\").\n \nPDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune® HPV + pembrolizumab, and the triple combination of Versamune® HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune® HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune® HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination. \n \nThe FDA supported the strategy and development of the double a...