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  • 18 May 2021
    Immunocore announces dosing of first patient with ImmTAV® bispecific molecule for chronic Hepatitis B

    Immunocore Holdings Plc (Nasdaq: IMCR) (or the “Company”), a pioneering, clinical‐stage T cell receptor biotechnology company working to develop and commercialise a new generation of transformative medicines to address unmet needs in cancer, infection and autoimmune disease, today announces the dosing of the first patient in the first-in-human clinical trial of IMC-I109V, a new class of bispecific protein immunotherapy that is being developed for the treatment of patients with chronic hepatitis B (HBV) infection (CHB). Wholly owned IMC-I109V is the first candidate in development using Immunocore’s immune‐mobilising monoclonal T cell receptors against virus (ImmTAV®) platform to enter clinical trials.

    “Our aim, through this study, is to obtain further data assessing the safety and potential of this bispecific T cell receptor (TCR) to provide a functional cure for people with CHB,” commented Professor Man-Fung Yuen, Chief of Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong/Queen Mary Hospital and a principal investigator of the study. “Approximately one third of the world’s population shows serological evidence of past or present infection with HBV and 240 million people are chronic carriers of the virus. Among patients with CHB, 25% will develop primary liver cancer or cirrhosis. Current treatment options require lifelong adherence to be effective, presenting us with an urgent need for new and innovative therapeutic options.”

    The trial is an open label study evaluating the safety, antiviral activity, and pharmacokinetics of IMC-I109V in HLA-A*02:01 positive patients with Chronic HBV who are non-cirrhotic, hepatitis B antigen-negative, and virally suppressed.

    IMC-I109V is an immunotherapeutic approach designed to potentially and specifically eliminate HBV-infected hepatocytes expressing hepatitis B surface antigen (HBsAg) via T cell redirection. IMC-I109V is designed to overcome T cell dysfunction by recruiting non-exhausted T cells to eliminate hepatocytes harbouring covalently closed circular DNA or integrated HBV DNA. Elimination of these cells is necessary to achieve a state of ‘Functional Cure’ defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment.