Immunocore presents Phase 1 data for hepatitis B candidate at AASLD's The Liver Meeting

Core Insights - The article discusses the Phase 1 trial results of IMC-I109V, a bispecific T cell receptor designed to target HBV-infected hepatocytes, demonstrating a manageable safety profile and antiviral activity [1][2][3] Company Overview - Immunocore Holdings plc is a commercial-stage biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [1][11] - The company is advancing clinical candidates aimed at achieving functional cures for HIV and hepatitis B virus (HBV) [10] Trial Details - The Phase 1 trial enrolled 20 participants, evaluating ascending doses of IMC-I109V (0.8 mcg, 2.4 mcg, 7 mcg, 20 mcg) administered as a single IV infusion [3][4] - Participants were assessed for safety, tolerability, pharmacokinetics, and pharmacodynamic activity up to week 4 [4] Efficacy Results - Dose-dependent decreases in serum HBsAg were observed, with reductions meeting the threshold of ≥ 0.2 log10 IU/ml in 4 individuals, indicating potential for resolving hepatitis B infection [5][6] - Consistent pharmacodynamic activity was noted at doses ≥ 7 mcg, with HBsAg levels typically reaching a nadir by day 8 [5] Safety Profile - Treatment-related adverse events were reported in 8 participants, primarily transient systemic symptoms, with ALT elevations resolving within 14 days [6][7] - One participant in the 20 mcg cohort experienced Grade 2 cytokine release syndrome, which resolved rapidly with treatment [7] Mechanism of Action - IMC-I109V is designed to recruit non-exhausted T cells to eliminate hepatocytes harboring HBV DNA, addressing HBV-specific T cell exhaustion [8] Future Directions - The company believes the initial evidence of HBsAg reduction supports further evaluation of IMC-I109V in multiple dose regimens [8]