Lion TCR, a Singapore-based clinical-stage biotechnology company involved in T-cell receptor (TCR)-based therapies, announced on Sunday that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase1b/2 clinical trials for its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB).

This approval represents the third major regulatory milestone for the same product candidate, which previously received both Fast Track and Orphan Drug Designations for the treatment of hepatitis B virus-related hepatocellular carcinoma (HBV-HCC).

The IND clearance authorises Lion TCR to commence clinical studies of LioCyx-M004 in CHB patients – a global population exceeding 290 million – and marks the first TCR-T therapy to enter clinical development for chronic hepatitis B.

Lion says that LioCyx-M004 is an innovative autologous cell therapy engineered using mRNA to encode T-cell receptors that specifically target hepatitis B virus antigens. Preclinical and early clinical studies have demonstrated the therapy's ability to reduce viral antigen load and promote T-cell-mediated clearance of infected cells, while maintaining a favourable safety profile to date.