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Initiation of peanut allergy biomarker study
Initiation of peanut allergy biomarker study.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 5198K\n Allergy Therapeutics PLC\n 05 January 2021\n \n \n \n \n \n \n \n Allergy Therapeutics plc\n \n \n (\"Allergy Therapeutics\", \"ATL\" or the \"Group\")\n \n \n \n \n \n \n \n \n Allergy Therapeutics initiates peanut allergy biomarker study with Imperial College London to confirm potential of novel peanut vaccine candidate\n \n \n \n \n \n - Ex-vivo biomarker study to evaluate VLP-based peanut allergy vaccine candidate's hypoallergic potential and potent immune response\n \n \n - Findings to support peanut clinical programme with first-in-human trial on track for 2021\n \n \n - Short-course vaccine candidate represents significant differentiated opportunity in $8bn worldwide food allergy market\n \n \n - IND application to United States Food and Drug Administration expected in 2021\n \n \n \n \n \n \n 5 January 2021 \n \n Allergy Therapeutics (AIM: AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that an ex-vivo biomarker study of blood samples from peanut allergy patients has begun at Imperial College London. The study aims to evaluate the Group's novel virus like particle (VLP) based peanut allergy vaccine candidate, to confirm its hypoallergic potential and its potent immune response. \n \n \n \n \n \n The study at Imperial College London, using human samples and an extensive set of functional and molecular biomarkers, will provide Allergy Therapeutics with important information to establish the starting dose for its first-in-human Phase I study. The data will also act as an early clinical predictor of efficacy of the VLP platform and support the acceptance of the Investigational New Drug (IND) application and a successful Phase I trial outcome. The submission of an IND application to the United States Food and Drug Administration (FDA) for that study is expected in 2021.\n \n \n \n \n \n Allergy Therapeutic's peanut allergy vaccine programme is supported by a strong preclinical research package, providing pre-clinical proof of concept for sustained immunity and protection against peanut anaphylaxis after a single vaccination. \n \n \n \n \n \n Importantly, in contrast to current treatment approaches such as desensitisation via oral administration or t...