#Singapore #FDA Approval #Liocyx-M004 #Lion TCR

Lion TCR's Liocyx-M004 Gains FDA Clearance for Liver Cancer Treatment

On February 12, 2025, Lion TCR announced a significant milestone in the battle against liver cancer with the FDA's approval of its mRNA-encoded T-cell receptor (TCR) therapy, Liocyx-M004. This groundbreaking therapy is set to undergo an international multicenter Phase 2 clinical trial, marking a pivotal moment for Lion TCR and offering renewed hope to patients dealing with HBV-related hepatocellular carcinoma (HCC).

Understanding the Challenge of Hepatitis B and Liver Cancer

Hepatitis B virus (HBV) infection remains a pressing global public health issue, significantly elevating the risk of liver cancer, especially HCC. Approximately 296 million individuals worldwide are affected by chronic HBV infection, leading to liver cancer being recognized as the sixth most prevalent cancer globally. In the year 2020, liver cancer accounted for around 905,000 new cases and resulted in approximately 830,000 deaths.

The significance of Liocyx-M004 lies in its unique approach—it is the first mRNA-encoded TCR-T therapy specifically targeting HBV-related hepatocellular carcinoma. The forthcoming Phase 2 trial aims to evaluate its effectiveness both as a standalone treatment and in conjunction with lenvatinib, a recognized first-line therapy for advanced HCC. Lenvatinib has been noted for its ability to transform the immunosuppressive tumor environment into one that supports immune activity, potentially heightening the effectiveness of treatments.

The Science Behind Liocyx-M004

Dr. Tina Wang, Chief Medical Officer and COO at Lion TCR, emphasized the common issue of exhausted HBV-specific T cells in patients suffering from HBV-related HCC. This exhaustion severely hampers their capacity to combat liver cancer cells and HBV-infected liver cells. Research indicates that HBV-specific TCR-T cells can effectively identify and eliminate these malignant cells.

Lion TCR's development strategy focuses on restoring the functional HBV-specific T cell pool through the adoptive transfer of these modified T cells. This therapeutic approach offers a targeted method for destroying both cancerous and infected liver cells expressing HBV antigens, thus presenting a novel solution for addressing HBV-related HCC.

Despite advancements in systemic therapies for liver cancer, particularly with the rise of targeted combination immunotherapies, precision medicine options specifically for HBV-related HCC remain scarce. Lion TCR's exploration of the combined application of Liocyx-M004 with lenvatinib seeks to enhance response rates and improve survival for affected patients.

Looking Ahead

CEO Dr. Xiaoming Peng highlighted the groundbreaking nature of Liocyx-M004, noting its distinction as the first TCR-T therapy targeting HBV viral antigens to achieve IND approval from the FDA, as well as receiving Fast Track designation. This recent FDA endorsement propels Lion TCR closer to realizing commercial applications for this innovative therapy, a crucial step in its journey from clinical trials to market.

In addition to advancing Liocyx-M004 through critical trials, Lion TCR is focused on developing a universal in vivo TCR-T product platform that utilizes mRNA-LNP technology, which will help lower production costs. The firm is also enhancing its AI-powered TCR discovery platform, expanding its pipeline to tackle other solid tumors such as lung and breast cancers.

Having successfully raised over 300 million yuan in funding from notable investors, including the Guangzhou Industrial Investment Fund, Lion TCR is establishing a significant presence in the biotechnology space. With its headquarters situated in Guangzhou and a complementary GMP-compliant drug manufacturing facility, Lion TCR is poised to become a leader in mRNA-encoded TCR-T cell therapies globally.

As clinical trials progress, Lion TCR is diligently collecting data to accelerate the availability of this promising treatment, with Liocyx-M004 displaying encouraging results in earlier studies, where it achieved a median overall survival rate of 33.1 months among patients with HBV-related HCC. The future of liver cancer treatment looks brighter with the continual innovations and advancements being made by Lion TCR.