The TCR-T research and development project of Xiang Xue Pharmaceuticals has been approved for clinical trials of the drug in the United States

Guangzhou Xiang Xue Pharmaceutical Co., Ltd., a controlling subsidiary of Guangdong Xiang Xue Precision Medical Technology Co., Ltd., said that recently, the company received a notice from Atsenex, the U.S. Food and Drug Administration (FDA) approved TCRT-ESO-A2 new drug clinical trial application (IND), the new drug can enter clinical trials.Basics of drugs licensed for clinical trials in the United States: 1, Drug Name: TCRT-ESO-A2 2, Applicant Name: ATHENEX, INC.3, adaptive disorders: used to treat tissue genotype HLA-A x 02:01, tumor antigen NY-ESO-1 expression as positive solid tumor.TCRT-ESO-A2 and Xiang Xue's precise product TEST16001 injections both express the same affinity-enhanced T-cells (TCR).Xiang Xue precision has established TCR-T complete technology platform and process, with complete independent intellectual property rights, its research and development pipeline's first product TEST16001 injection, targeted at HLA-A-02:01 and NY-ESO-1 antigen peptides Composed of complexes that use lysovirus transductive transgenerate T cells without self-replicating ability to express NY-ESO-1 antigen-specific TCR, clinical PI studies have shown that patients treated with TAEST16001 have long-term maintenance of their returned T cells in the body, and reflect better therapeutic results.At present, THEEST16001 open, single-arm, early clinical research project for patients with late-stage malignant solid tumors based on soft tissue sarcoma is being conducted in the biothermal treatment center of Sun Yat-sen University Cancer Hospital and the melanoma and sarcoma internal disease area.TCR-T cell therapy technology in line with the company's product ladder construction strategy, is conducive to consolidate and improve the company's position in the field of immunocellular therapy, enrich the company's product line in the field of anti-tumor drugs, enhance the company's core competitiveness. TCRT-ESO-A2's approval for a new U.S. drug clinical trial is a phased result of TCR-T's new drug development, and it is not expected that the application for a license for this clinical trial will have a significant impact on the company's 2020 results.After TCRT-ESO-A2 has obtained a clinical trial license for the drug, Athenex will organize clinical trials and apply for registration approval as required by clinical trials in the United States. (Sina Pharmaceutical News)