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Recently, GuangDong XIANGXUE LIFE SCIENCES LTD (referred to as "Xiangxue Life Sciences") submitted a clinical registration application for a new indication of TAEST16001 injection to the National Medical Products Administration (NMPA) and it has been accepted.TAEST16001 Injection is the first TCR-T cell immunotherapy product in China to have obtained an IND approval. Its first clinical indication under research is advanced soft tissue sarcoma, and it has currently entered Phase II clinical trials with smooth progress.
TAEST16001 is a TCR-T cell immunotherapy product independently developed by GuangDong XIANGXUE LIFE SCIENCES LTD, targeting NY-ESO-1.Carcinoembryonic AntigenTCR-T cells, where the patient's T cells are genetically engineered in vitro to carry tumor antigen specificityTCR GeneLentivirus transfection, followed by the expansion of T cells expressing tumor antigen-specific TCR to approximately 1×10^9~2×10^10 cells. Patients undergo lymphodepletion with an appropriate dose of medication (Clearing) and then the TCR-T cells are infused back into the patient.TAEST16001 is currently under research for its first indication, advanced soft tissue sarcoma, in Guangzhou.Sun Yat-sen University Cancer CenterLed by Peking University Cancer Hospital, multiple clinical institutions in China are participating.Phase II Clinical Study。The first Phase I clinical trial of this product was a dose-escalation and expansion study of TAEST16001 cells in HLA-A*02:01-positive patients with advanced soft tissue sarcoma expressing the NY-ESO-1 antigen. The Phase I clinical research results of TAEST16001 were honored to be selected for an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, where the initial public clinical data received high recognition from the industry. In 2023, the prestigious international journal Cell Reports Medicine published the Phase I clinical research article and invited a senior professor from Northwestern University to provide a special commentary on the article, offering high praise: "The Phase I clinical study of TAEST16001 represents a crucial step forward in the clinical translation of adoptive T-cell immunotherapy for advanced soft tissue sarcoma."About Xiangxue Life SciencesXiangxue Life Sciences Technology (Guangdong) Co., Ltd. (referred to as "Xiangxue Life Sciences") is a research and development enterprise focusing on TCR-T cell immunotherapy products and technologies, and is a leading company in TCR-T cell immunotherapy both in China and internationally.GuangDong XIANGXUE LIFE SCIENCES LTD has an experienced and rigorous R&D team. Based on its proprietary TCR core technology, the company has established a complete TCR-T product research and development technology system and production preparation system. The TCR-T product R&D technology system includes: ① Antigen peptide discovery platform, ② High-affinity TCR platform, ③ TCR-T development platform; the TCR-T production preparation system includes: ① Automated cell production platform, ② Quality control platform, forming a full-chain innovative industrial chain for TCR-T cell products.Xiangxue Life Sciences’ TCR-T Product Portfolio is Broad, with Rich Targets Including CT Antigens, Neoantigens, Viral Antigens, and Nearly All Tumor-Specific Antigens. It Covers Multiple HLA Genotypes Predominant in the Chinese Population, Such as A0201, A1101, and A2402, with Indications Encompassing Various Clinically Difficult-to-Treat Solid Tumors.Currently, GuangDong XIANGXUE LIFE SCIENCES LTD has two products under research that have been approved by China's CDE to enter clinical trials. TAEST16001 is China’s first TCR-T cell therapy product to receive an IND approval to enter clinical trials; the second product, TAEST1901, has primary liver cancer as its first indication under research and is initiating Phase I clinical studies.Source of the article: Xiangxue Life Sciences
