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IMC-I109V is a novel, soluble bispecific protein therapeutic developed for the treatment of chronic hepatitis B virus (HBV) infection. It belongs to the ImmTAV (immune-mobilizing monoclonal T cell receptor against viruses) class and functions as a T cell receptor (TCR) bispecific molecule. IMC-I109V is designed to specifically eliminate HBV-infected hepatocytes that express hepatitis B surface antigen (HBsAg) by redirecting non-exhausted T cells toward these infected cells, thereby overcoming T cell dysfunction commonly seen in chronic HBV infection. The mechanism involves binding to viral peptide-HLA complexes on infected hepatocytes and engaging CD3 on T cells, leading to targeted lysis of infected liver cells harboring covalently closed circular DNA or integrated HBV DNA. This approach aims for a "functional cure," defined as sustained HBsAg loss and undetectable HBV DNA six months post-treatment. The drug is currently being evaluated in first-in-human clinical trials for safety, tolerability, pharmacokinetics, antiviral activity in patients with chronic hepatitis B who are virally suppressed and HBeAg-negative; it is also being studied in patients with HBV-associated hepatocellular carcinoma[1][3][4][5][6].
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