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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 further solidifies Lion TCR's leading position in the field of global innovative therapies and brings 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. The number of existing chronic hepatitis B patients in China has exceeded 86 million, and nearly 400,000 new HBV-related HCC patients are added 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 monotherapy and in combination with lenvatinib. Lenvatinib, as a standard first-line treatment for advanced hepatocellular carcinoma, has the potential to improve the tumor immune microenvironment, and its combination with Liocyx-M004 is expected to provide complementary advantages, further enhancing the anti-tumor efficacy in patients.
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 their HBV-specific T cell functions and an inability 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, the adoptive transfer and replenishment of autologous HBV-specific TCR-T cells in patients represents 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 of targeted and immunotherapy systems has gradually been established, there remains a lack of precision therapies specifically targeting HBV-related hepatocellular carcinoma. By evaluating the combination of Liocyx-M004 and lenvatinib, we look forward to further improving response rates and survival outcomes for patients with HBV-related hepatocellular carcinoma. The FDA’s approval of this international multicenter clinical trial to proceed to Phase 2 has injected strong confidence and momentum into Guangzhou Laien Biological Medicine Co., Ltd.'s ongoing efforts in mRNA-encoded TCR-T therapy for hepatocellular carcinoma. Moving forward, we will accelerate the progress of Phase 2 clinical trials and the accumulation of clinical data, striving to benefit patients as soon as possible."Dr. Peng Xiaoming, 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 it is also the first drug of its kind to be granted Fast Track designation by the FDA. This time, the FDA's 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 represents a key step in the company’s transition from the clinical stage to commercialization. While focusing on actively advancing its leading product pipeline into the international multicenter Phase 2 clinical trial, the company is also accelerating the development of an in vivo TCR-T “off-the-shelf” (also referred to as “universal”) product platform based on mRNA-LNP delivery technology, which is expected to significantly reduce production costs. Meanwhile, the company is upgrading its AI-powered TCR novel target discovery platform to expand its product pipeline 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 a median overall survival of 33.1 months in patients with HBV-related hepatocellular carcinoma.
