SCG's autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR-T) therapy, SCG101, targeting hepatitis B surface antigen (HBsAg), has demonstrated promising antiviral activity in a Phase I clinical trial. The trial focused on individuals with advanced HBV-related hepatocellular carcinoma (HBV-HCC).
Antiviral Activity and Safety
The Phase I trial involved 12 subjects who received a single intravenous dose of SCG101, ranging from 5.0×10⁷ to 1.0×10⁸ TCR+ T cells/kg. Results indicated that all subjects experienced a significant decrease in serum HBsAg levels, with 92% achieving a reduction of 1.0 to 4.6 log₁₀. The reduced levels persisted below 100 IU/mL for up to one year, and four subjects experienced complete HBsAg loss within 21 days post-infusion.
The therapy was generally well-tolerated, with a favorable safety profile. The most common adverse events were consistent with the therapy's mechanism of action, involving targeted immune activation and clearance of diseased hepatocytes and HCC cells.
Regulatory Approvals and Future Development
SCG101 has received trial approvals from several regulatory bodies, including the China National Medical Products Administration (NMPA), the US Food and Drug Administration (FDA), the Hong Kong Department of Health (DOH), and the Singapore Health Sciences Authority (HSA). A Phase I/II trial assessing SCG101 is currently in progress.
Expert Commentary
SCG cell therapy CEO Christy Ma stated, "The positive data from our Phase I trial marks a significant milestone in the development of SCG101, our first-in-class HBV-specific TCR-T therapy. These results not only demonstrate the potential of SCG101 to achieve meaningful and durable antiviral responses in patients but also underscore the unique approach we are taking in HBV-specific TCR T cell therapy. We are encouraged by these early findings and are committed to advancing SCG101 through clinical development as we work towards providing a new therapeutic option for patients suffering from this challenging disease."
