Singapore-based clinical-stage biotechnology company SCG Cell Therapy Pte Ltd (SCG) on Wednesday reported late-breaking clinical data from its Phase 1 trial evaluating SCG101, autologous HBV-specific TCR-T cell therapy, in patients with advanced HBV-related hepatocellular carcinoma (HCC).
Presented at the European Association for the Study of the Liver (EASL) Congress 2025, the results demonstrate that SCG101 led to sustained clearance of serum hepatitis B surface antigen (HBsAg) and HBV-DNA in heavily pre-treated patients with HBV-related HCC. Notably, 94% of patients had received prior nucleoside analogue (NA) antiviral therapy, and 72% presented with liver cirrhosis at baseline. Following a single-dose SCG101 infusion, all treated patients experienced a rapid decline in serum HBsAg, with 94%(16/17) achieving a 1.0-4.6 log reduction within 28 days and persisting < 100 lU/mL for up to one year. Four patients (23.5%) achieved HBsAg loss.
In addition to its antiviral effects, the company says that SCG101 demonstrated encouraging anti-tumour activity. SCG101 was generally well tolerated, with a good safety profile.
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