Business
PDS Biotech: 2nd Quarter Results, Business Update
PDS Biotech: 2nd Quarter Results, Business Update.
About this update from Emv Capital Plc
[{"type":"text","content":"\n\nRNS: For immediate release\nNetScientific plc\nPDS Biotechnology Reports Second Quarter 2023 Financial Results and Provides Business Update\nSuccessful submission of final clinical protocol and supporting CMC information to FDA to initiate Phase 3 VERSATILE-003 trial in the fourth quarter 2023\nBiomarker data from VERSATILE-002 to be presented at ESMO 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 released its financial results for the quarter ended 30 June 2023 and has provided a business update.\nRecent Business Highlights:\nPDS0101 Lead Drug Candidate\n· VERSATILE-003: Submitted the final Phase 3 clinical protocol and supporting Chemistry, Manufacturing and Controls (CMC) information to the U.S. Food and Drug Administration (FDA) to enable initiation of the VERSATILE-003 randomized, controlled multicenter study of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer in the fourth quarter 2023\n· VERSATILE-002: Phase 2 open-label, multicenter study of PDS0101 in combination with KEYTRUDA® in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer\no Announced clinical immune response data to be presented at upcoming European Society for Medical Oncology (ESMO) Congress 2023\n§ Biomarker data highlighting HPV16-specific killer and helper T cell responses will be presented\no Presented interim data at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, demonstrating a 12-month overall survival rate of 87%, with only 8% of patients experiencing Grade 3 treatment-related adverse events, and no reports of more severe Grade 4 or 5 adverse events\no Achieved the efficacy threshold in Stage 2 of this clinical trial for the naïve patient arm\n§ 14 patients in the immune checkpoint inhibitor (ICI) naïve arm experienced either a complete response or p...