FDA Grants Multiple Approvals to Lion TCR in 2025, Authorizing Investigational New Drug for Hepatitis B T-Cell Receptor Therapy
Lion TCR, a biotechnology company specialising in T-cell receptor (TCR) discovery, is making strides in the field of in-vivo TCR-T therapy. Their latest product, LioCyx-M004, is an autologous cell therapy engineered using mRNA to target hepatitis B antigens.
Preclinical and early clinical studies have demonstrated LioCyx-M004's ability to reduce hepatitis B antigen load and promote T-cell-mediated clearance of infected cells. This could potentially expand treatment opportunities for patients worldwide, including those with chronic hepatitis B (CHB), a condition affecting over 290 million people globally.
The favourable safety profile of LioCyx-M004, as demonstrated to date, is a significant advantage. Lion TCR's strategic approach to targeting hepatitis B through TCR-T cell therapy has received validation from a prominent U.S. cancer research institute.
Lion TCR is actively advancing this innovative approach, accelerating the development of in-vivo TCR-T therapy. The in-vivo platform offers distinct advantages, including shorter production cycles, reduced costs, and enhanced accessibility.
Significant efficacy in eliminating hepatitis B-positive cells in animal models has been demonstrated, with therapeutic effects comparable to ex-vivo engineered T cells. Studies conducted at the University of Zurich validated the mRNA-encoded in-vivo TCR-T therapy by Lion TCR.
Lion TCR's earlier regulatory achievements include Orphan Drug designation and Fast Track status for the treatment of hepatitis B-related hepatocellular carcinoma (HBV-HCC). Fast Track status is designed to accelerate the development and review of treatments for serious conditions addressing unmet medical needs. Orphan Drug designation provides incentives for therapies targeting rare diseases such as hepatitis B in the United States.
Dr. Xiaoming Peng, CEO of Lion TCR, stated that the triple recognition from the FDA underscores the transformative potential of LioCyx-M004 and validates Lion TCR's strategic approach targeting hepatitis B through TCR-T cell therapy.
Lion TCR also plans to expand its product pipeline to address additional solid tumour indications, including lung cancer, breast cancer, and gastrointestinal cancers. The company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate phase 1b/2 clinical trials for LioCyx-M004 in patients with chronic hepatitis B, making it the first TCR-T therapy to enter clinical development for this condition.
