Drug intelligence / Profile preview

IMC-I109V

Development stage
Unknown
Lead developer
Immunocore
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

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].

Other names
HBV HCC Module MAD
02

Targets

HBsAg S20-28/HLA-A*02:01 (HBsAg S20-28 peptide-HLA-A*02:01 complex)CD3 (T-cell surface glycoprotein CD3)

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