SCG Cell Therapy Pte Ltd (SCG), a Singapore-based clinical-stage biotechnology company involved in TCR T cell therapy for infectious diseases and associated cancers, announced on Monday that the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for SCG101V, marking the first-ever investigational cell therapy to enter regulatory approved Phase 1/2 clinical trial for chronic hepatitis B virus (HBV) infection.

SCG101 is designed to cure chronic hepatitis B by eliminating HBV cccDNA and HBV-DNA integration within HBV-infected hepatocytes, which are the fundamental source of persistent infection and antigen production. These infected hepatocytes serve as the long-term viral reservoir that current antiviral therapies fail to eradicate.

'SCG101 is designed to mimic the natural immune response observed in individuals who are able to clear HBV infection spontaneously. HBV-specific T cells play a central role in this process and, remarkably, through genetic engineering of T cells, we were able to replicate this natural process as demonstrated in our preclinical models and clinical data in hepatocellular carcinoma, providing strong evidence that this promise holds true in hepatitis B patients,' said Professor Ulrike Protzer, Scientific Founder of SCG Cell Therapy and director of Institute of Virology Technical University of Munich / Helmholtz Munich.

The company reported that in the Phase 1 clinical trial of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC), SCG101 demonstrated a good safety profile and sustained clearance of serum hepatitis B surface antigen (HBsAg), even in heavily pre-treated patients.