The First TCR-T Product For The Treatment of Liver Cancer Was Approved For Clinical Use

On April 20, Guangzhou Xiangxue Pharmaceutical announced that its grandson company Xiangxue Life Sciences TCR-T therapeutic product TAEST1901 injection was approved for clinical use. It is used to treat advanced liver cancer or other advanced tumors whose tissue genotype is HLA-A*02:01 and the expression of tumor antigen AFP is positive. There is no report on the use of TCR-T in the treatment of liver cancer in my country, especially the treatment of liver cancer with high-affinity anti-AFP-specific TCR-T should be the first time.

In recent years, T cell receptor biopharmaceuticals have received high attention in the industry. The core part of the T cell receptor (TCR) can recognize most antigens, including extracellular, membrane, intracellular and nuclear antigens, and play a therapeutic role. T cell therapy technologies include chimeric antigen receptor T cell technology (CAR-T) and genetically modified T cell receptor (TCR) chimeric T cells (TCR-T). Genetic modification methods improve the ability of T cell receptors to recognize and attack specific cancer cell antigens. As the two latest immune cell technologies of the current adoptive cell infusion therapy ACT technology, because it can express specific receptor targeting Identifying specific cells such as tumor cells has received extensive attention and research. Compared with CAR-T therapy, TCR-T has obvious advantages in the treatment of solid tumors and safety, and has become a research hotspot in immune cell therapy.

TAEST1901 injection is the second TCR-T product approved for clinical trials after Xiangxue Life Sciences obtained the IND approval for the first TCR-T product (TAEST16001 injection) in China in March 2019.

TAEST1901 injection is a HLA-A*02:01/AFP specific affinity-enhanced TCR-T therapeutic product, targeting the complex composed of HLA-A*02:01 and AFP antigenic peptides. Autologous T cells express AFP antigen-specific TCR.

Through systematic preclinical studies, TAEST1901 injection showed good safety. At the same time, it has good specific efficacy against HLA-A*02:01 and AFP double-positive target cells in vivo/in vitro. At present, Xiangxue Life Sciences has completed the preclinical research work on the new TCR-T drug TAES1901 in China for hepatocellular carcinoma whose genotype is HLA-A*02:01 and the tumor antigen AFP expression is positive.