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PDS completes FDA meeting for triple combination
PDS completes FDA meeting for triple combination.
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[{"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 completes successful meeting with FDA for triple combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor\n \n \n \n \n Received guidance on registrational path for combination in recurrent/metastatic, immune checkpoint inhibitor refractory 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 the successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) for a combination therapy of PDS0101, PDS0301 and an FDA-approved immune checkpoint inhibitor (ICI) for the treatment of recurrent/metastatic human papilloma virus (HPV)-positive, ICI refractory head and neck cancer.\n \n \n In recent interactions with the FDA, PDS Biotech has confirmed the required contents of the study design for a potential registrational trial of the combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor. PDS0101, PDS Biotech's lead candidate, is a Versamune® based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. PDS0301 is a novel, proprietary investigational tumour-targeting fusion protein of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumour microenvironment, and is designed to overcome tumour immune suppression utilizing a different mechanism from checkpoint inhibitors.\n \n \n The combination of Versamune® and IL-12 is patented by PDS Biotech. In a National Cancer Institute (NCI)-led clinical trial in advanced HPV-positive ICI refractory patients, the combination of PDS0101 and PDS0301 administered with an investigational bi-functional ICI resulted in a median overall survival of 21 months, which compares favourably to the historical median survival of 3-4 months.\n \n \n \n Dr Frank Bedu-Addo, Chief Executive Officer of PDS Biotech, said:\n \n \...