Business
PDS Business Update and 2022 Financial Results
PDS Business Update and 2022 Financial Results.
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 Provides Business Update and Reports Fourth-Quarter and Full-Year 2022 Financial Results\n \n \n \n \n Successful meeting with FDA to discuss registrational pathway for triple combination of PDS0101, PDS0301, and a commercial immune checkpoint inhibitor\n \n \n \n \n 100% (9/9) clinical response (>60% tumour shrinkage at mid-point evaluation) in IMMUNOCERV trial for high-risk cervical cancer patients with tumours >5 cm in PDS0101 + CRT based on preliminary data\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 provided a business update and announced its financial results for the year ended December 31, 2022.\n \n \n \n Fourth Quarter 2022 and Recent Business Highlights:\n \n \n \n ·\n \n PDS0101 Lead Drug Candidate\n \n \n \n ·\n \n VERSATILE-002 Phase 2 combination trial\n \n with Merck & Co. Inc.'s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer.\n \n \n ·\n Completed first stage of enrollment in checkpoint inhibitor refractory arm\n \n \n ·\n Presented initial data on methods for investigating efficacy of PDS0101 in combination with KEYTRUDA® (pembrolizumab) with respect to T cell activation and functionality at the ESMO Targeted Anticancer Therapies Congress 2023\n \n \n ·\n \n National Cancer Institute (NCI)-led Phase 2 triple combination trial\n \n in patients with advanced HPV-positive cancers.\n \n \n ·\n Successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)\n \n \n ·\n Reported median overall survival (OS) of 21 months in advanced, ICI refractory cancer HPV-positive patients (N=29) having few remaining treatment options\n \n \n ·\n \n IMMUNOCERV\n \n Phase 2 clinical trial of PDS0101 wi...