Xiangxue Precision's TCR-T Therapy TAEST16001 Granted Breakthrough Therapy Designation for Soft Tissue Sarcoma

On July 22, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) disclosed that GuangDong XIANGXUE LIFE SCIENCES LTD (referred to as "XIANGXUE LIFE SCIENCES”) The TAEST16001 injection, filed by GuangDong XIANGXUE LIFE SCIENCES LTD, is proposed to be included in the breakthrough treatment category forTreatment for Soft Tissue Sarcoma with HLA-A*02:01 Genotype and Positive Expression of Tumor Antigen NY-ESO-1。

▲ Image Source: CDE Official Website

TAEST16001 Injection, developed by Xiangxue Life Sciences (a subsidiary of GuangDong XIANGXUE LIFE SCIENCES LTD), is an affinity-enhanced TCR-T cell immunotherapy product targeting NY-ESO-1. CurrentlyTAEST16001TargetingAdvanced Soft Tissue SarcomaThe research on indications has completed Phase 1 clinical trials, and Phase 2 clinical trials are currently underway. The results of the Phase 1 clinical trial for the treatment of patients with advanced soft tissue sarcoma were orally presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in an international journal in August 2023.Cell Reports Medicine. During the preliminary analysis,Among 12 patients, the best response was partial response in 5 cases, with an objective response rate (ORR) of 41.7%.。

In 2024, the interim summary data of the Phase 2 clinical trial for TAEST16001's first clinical indication, advanced soft tissue sarcoma, was once again selected for the ASCO Annual Meeting. The early Phase 2 clinical data of TAEST16001 demonstrated consistent controllable safety and tolerability with the previous Phase 1 study. According to RECIST 1.1,The best response rate assessed by the Independent Radiology Committee (IRC) was 50% (4/8).The median progression-free survival (mPFS) assessed by the Independent Imaging Assessment Committee and investigators was 5.9 months. Currently, most subjects are still in follow-up.

TAEST16001 transfects patients' T cells in vitro with a lentivirus carrying genetically engineered TCR genes specific to tumor antigens, and then these T cells expressing antitumor antigen TCR are expanded to approximately 1×10.⁹~2×10¹⁰A certain number of cells, after the patient undergoes lymphocyte depletion (LD) with an appropriate dose of medication, the TCR-T cells are reinfused into the patient.

▲ Image Source: Company Official Website

According to the official website,The essence of cellular immunotherapy is targeting immune cells,Mobilize the patient's own natural anti-cancer immune function cells—T cells to take effect.The main feature is to enhance the patient's own immune function to eliminate minimal residual tumor lesions and significantly inhibit the proliferation of tumor cells., with the advantages of fewer side effects and low recurrence rate, is a better choice for older patients with poor immune function who are afraid of the toxic side effects of radiotherapy and chemotherapy. This therapy is suitable for all stages of cancer, not only for the treatment of early-stage tumor patients, but also some late-stage cancer patients can achieve partial or complete remission after biological immunotherapy. It is currently mainly used in various malignant tumors such as prostate cancer, malignant melanoma, lung cancer, nasopharyngeal cancer, liver cancer, and stomach cancer.

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