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Recently, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that TAEST16001 Injection, a TCR-T therapy targeting NY-ESO-1 independently developed by Xiangxue Life Science Technology (Guangdong) Co., Ltd. (referred to as Xiangxue Life Sciences), a holding subsidiary of GuangDong XIANGXUE LIFE SCIENCES LTD, has been granted clinical trial approval by default. It is intended for the treatment of advanced non-small cell lung cancer patients with the HLA-A*02:01 genotype and positive expression of the tumor antigen NY-ESO-1.
TAEST16001 Injection is the first TCR-T cell therapy product developed based on the TCR-T cell product technology development platform and production preparation system of Xiangxue Life Sciences. It involves genetically engineering the patient's T cells ex vivo, transducing them with a lentivirus carrying the TCR gene specific to the NY-ESO-1 tumor antigen, expanding the TCR-T cells in vitro, and then reinfusing them back into the patient to effectively treat tumors.TAEST16001 is the first TCRT cell product in China to receive an IND approval and initiate clinical research. The first indication is for advanced soft tissue sarcoma that is HLA-A*02:01 positive and expresses the NY-ESO-1 antigen. Clinical trials are being led by the Sun Yat-sen University Cancer Center and Peking University Cancer Hospital in China. Currently, the Phase I clinical trial and the first stage of the Phase II clinical trial have been completed. In the clinical trial, significant clinical efficacy and manageable safety were observed in patients with advanced soft tissue sarcoma who had failed standard systemic treatments and lacked effective therapeutic options. The results of TAEST16001's Phase I clinical trial were recognized at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, where they were orally presented in the sarcoma session. The initial public disclosure of the clinical trial data showed an objective response rate (ORR) of 41.7%. The clinical study results on the safety and efficacy of TAEST16001 were comparable to those of products targeting the same antigen developed by renowned international pharmaceutical companies, gaining recognition from global peers and significant attention within the industry. The results of TAEST16001's Phase I clinical trial were published in the prestigious international journal Cell Reports Medicine (IF=16.988) in August 2023. The journal featured a special commentary by a professor from Northwestern University in the U.S., who highly praised the study, stating that the Phase I clinical trial of TAEST16001 marked a crucial step in the clinical translation of adoptive T-cell immunotherapy for advanced soft tissue sarcoma. In June 2024, the interim summary data from TAEST16001's Phase II clinical trial was again selected for presentation at the ASCO Annual Meeting. Data disclosed for the first time in poster form showed that, according to RECIST 1.1, the best response rate assessed by the Independent Radiologic Review Committee (IRC) was 50%, and the median progression-free survival (mPFS) assessed by both the IRC and investigators was 5.9 months. The data demonstrating the significant clinical efficacy of TAEST16001 were once again acknowledged at an internationally top-tier academic conference.About Xiangxue Life SciencesXiangxue Life Science Technology (Guangdong) Co., Ltd. ("Xiangxue Life Sciences" for short) is a subsidiary controlled by Xiangxue Pharmaceutical. It is a leading company in the field of TCR-T cell immunotherapy, focusing on the research and development of cell immunotherapy products and technologies in the TCR area. The company's vision is to "solve difficult problems in human health and set a benchmark in cancer treatment," with the mission to "focus on TCR, empower T cells, and conquer solid tumors."Xiangxue Life Sciences has proprietary intellectual property rights to core TCR technology, with a complete TCR-T cell therapy product technology R&D platform and production system. The TCR-T cell therapy product technology R&D platform includes: ① Antigen peptide discovery platform, ② High-affinity TCR platform, ③ TCR-T development platform; the TCR-T cell therapy product production system includes: ① Automated cell production platform, ② Quality control platform, forming an innovative industrial chain covering the entire process of TCR-T cell products.Xiangxue Life Sciences' TCR-T products and pipeline reserves are extensively laid out, with a rich array of targets including CT antigens, neoantigens, and viral antigens—nearly all tumor-related specific antigens. They cover multiple HLA genotypes predominant in the Chinese population, such as A0201, A1101, and A2402, and address indications across various clinically challenging solid tumors, placing them at an internationally leading level.Currently, Xiangxue Life Sciences has two products that have obtained IND approval in China. The first product is TAEST16001, indicated for soft tissue sarcoma, which has completed Phase I clinical trials and the first phase of Phase II clinical trials in China. It has been included in the list of breakthrough therapies and has received IND approval in the United States. The second product is TAEST1901, indicated for primary liver cancer, which is initiating Phase I clinical research. The third product, XLS103, indicated for advanced pancreatic cancer, non-small cell lung cancer, and colorectal cancer, is currently undergoing IND application.References: Public Information
