Singapore and Guangzhou, China / February 12, 2025 / PRNewswire:Recently, Lion TCR announced that its mRNA-encoded TCR-T cell therapy product, Liocyx-M004, has received approval from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial.This significant progress marks a further consolidation of Guangzhou Laien Biological Medicine Co., Ltd.'s leading position in the field of global innovative therapies, bringing new hope to patients with hepatocellular carcinoma (HCC).

China is a major country with hepatitis B and also a major country with liver cancer. Hepatocellular carcinoma (HCC) caused by hepatitis B virus (HBV) infection is one of the main risk factors. There are currently over 86 million people in China living with chronic hepatitis B, and nearly 400,000 new cases of HBV-related hepatocellular carcinoma occur each year. Liocyx-M004 is the world’s first mRNA-encoded TCR-T cell therapy targeting HBV-related hepatocellular carcinoma. The international multicenter Phase 2 clinical trial recently approved by the FDA will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib. Lenvatinib, a standard first-line treatment for advanced hepatocellular carcinoma, has potential functions in improving the tumor immune microenvironment. The combination therapy with Liocyx-M004 is expected to create synergistic advantages, further enhancing patients' anti-tumor efficacy.

Dr. Tingting Wang, Chief Medical Officer and Chief Operating Officer of Guangzhou Laien Biological Medicine Co., Ltd.Indicates:

"HBV-specific T cells in patients with HBV-related hepatocellular carcinoma are often functionally exhausted, leading to severe impairment of these patients' own HBV-specific T cell functions, which are unable to eliminate HBV-DNA integrated infected hepatocytes and hepatocellular carcinoma cells. Our research demonstrates that HBV-specific TCR-T cells can effectively eliminate hepatocellular carcinoma cells with HBV-DNA integration. Therefore, adoptive transfer and supplementation of autologous HBV-specific TCR-T cells in patients represent a promising therapeutic approach, with the potential to rebuild the HBV-specific T cell repertoire in patients and exert targeted killing of HBV antigen-expressing hepatocellular carcinoma cells and HBV-infected hepatocytes for the treatment of HBV-related hepatocellular carcinoma. In recent years, although significant progress has been made in systemic treatments for advanced hepatocellular carcinoma and a combination regimen of targeted therapy and immunotherapy has gradually been established, there is still a lack of precise therapies specifically targeting HBV-related hepatocellular carcinoma."By evaluating the combination of Liocyx-M004 and lenvatinib, we look forward to further improving the response rate and survival rate of patients with HBV-related hepatocellular carcinoma.FDA Approval of This International Multicenter Clinical Trial Entering Phase 2 Has Injected Strong Confidence and Momentum into Guangzhou Laien Biological Medicine Co., Ltd.'s Continued Efforts in mRNA-Encoded TCR-T Therapy for Hepatocellular Carcinoma; Next, We Will Accelerate the Progress of Phase 2 Clinical Trials and the Accumulation of Clinical Data to Benefit Patients as Soon as Possible.

Dr. Xiaoming Peng, CEO of Guangzhou Laien Biological Medicine Co., Ltd.Point out:

"Liocyx-M004 is the first TCR-T therapy targeting HBV viral antigens to be approved by the U.S. FDA, and also the first drug of its kind to be granted Fast Track designation by the FDA. This time, the FDA approval for Liocyx-M004 to enter an international multicenter Phase 2 clinical trial further highlights the significance of this therapy as an innovative treatment for liver cancer, marking another major milestone for Guangzhou Laien Biological Medicine Co., Ltd. It also signifies a critical step in the company’s transition from the clinical stage toward commercialization.While actively promoting the leading product pipeline into international multicenter Phase 2 clinical trials, the company is also accelerating the layout and development of an in vivo TCR-T off-the-shelf (also known as "universal") product platform based on mRNA-LNP delivery technology, which is expected to significantly reduce product costs. At the same time, the company is upgrading its AI-powered TCR neoantigen discovery platform to expand new product pipelines for treating various solid tumors, such as lung cancer, breast cancer, and gastrointestinal tumors."

It is reported that Laien Bio's Liocyx-M004 has shown encouraging results in earlier clinical trials, achieving success in patients with HBV-related hepatocellular carcinoma.A median overall survival of 33.1 months。

Reprinted from PR Newswire

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Highlights:

World's First! Laien Bio's mRNA-Encoded TCR-T Approved for Clinical Trials, Precisely Targeting Hepatocellular Carcinoma

Guangzhou Laien Biological Medicine Co., Ltd. Honored as "2024 Hurun China New Medical Powerhouse Enterprise"

Innovation-Driven! Guangzhou Laien Biological Medicine Co., Ltd. Honored with "Third Prize in the Final of the 13th China Innovation and Entrepreneurship Competition (Guangdong · Guangzhou Division)"

Laien Bio Strongly Ranks on the List! Honored as One of Guangzhou's "Future Unicorn" Innovative Enterprises

Reprint Academician Wang Fusheng: Clinical Research Progress in Immunotherapy for Chronic Hepatitis B

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