TAEST16001 will very likely be the first home-grown TCR-T (T cell Receptor-T) cell therapy to be launched in China.
According to Xiangxue Pharmaceutical (Chinese: 香雪制药, 300147), its TCR-T cell therapy product, TAEST16001, was presented as one of the highlights of immunotherapy in the 2022 annual meeting of the American Society of Clinical Oncology (ASCO22). Its Phase I clinical trial results received recognition from ASCO.
TAEST16001, developed by Xiangxue Life Sciences, the subsidiary of Xiangxue Pharmaceutical, aims to treat patients with solid tumor mainly containing soft tissue sarcoma. It is the first TCR-T cell therapy that gets IND (Investigational New Drug) approval in China. Meanwhile, it has received IND approval from FDA (Food and Drug Administration) in 2020.
According to the results of Phase I clinical trial conducted in China, up to December 31, 2021, among 12 patients with advanced soft tissue sarcoma who were enrolled in the trial, the objective response rate (ORR) of TAEST16001 was 41.7%. It shows comparable results with GSK’s product with the same target in terms of safety and efficacy. It also showed acceptable tolerability.
Xiangxue Pharmaceutical’s competitors include CorreGene (Chinese: 可瑞生物), Shenzhen Innovation Immunotechnology (Chinese: 深圳因诺免疫) and TCR Cure (Chinese: 天科雅) which all have TCR-T-related pipelines.