Lion TCR's Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study

Lion TCR’s Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study

Singapore-based clinical-stage biotechnology company Lion TCR, backed by Chinese investors, has received clearance from the US Food and Drug Administration (FDA) to initiate a global, multi-center Phase II study for its Liocyx-M00 therapy. The treatment involves autologous T-cells transfected with mRNA encoding hepatitis B surface antigen (HBsAg) specific toll cell receptor (TCR).

Therapy Details
Liocyx-M004, the world’s first mRNA-encoded TCR-T cell therapy for HBV-related hepatocellular carcinoma (HCC), will be evaluated for efficacy both as a monotherapy and in combination with lenvatinib, the standard first-line treatment for advanced HCC.

Study Objectives
The Phase II study aims to assess the safety and efficacy of Liocyx-M004 in treating patients with HBV-related HCC. The therapy’s innovative approach leverages mRNA technology to enhance T-cell targeting of cancer cells, potentially offering a new treatment option for patients with advanced liver cancer.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry