Tcelltech's TX103 CAR-T Cell Therapy Receives IND Approval in China for Malignant Glioma Treatment

Jan 31, 2024 11:43 CST Updated 11:43

Tcelltech

Developer of Immuno-oncology and Cell Therapy Drugs

Recently, Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. (Tcelltech)"TX103 CAR-T Cells" Granted IND Approval by China's Center for Drug Evaluation (CDE) for the Treatment of Malignant Glioma.

TX103 is an original CAR-T cell therapy drug developed by Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. that targets B7-H3 (CD276).Received FDA approval for clinical trials in the United States in September 2023; Also already in 2023In June, it received the FDA Orphan Drug Designation in the United States.。

TX103 Receives IND Approval from China's National Medical Products Administration Center for Drug Evaluation

TX103 is a CAR-T cell therapy drug independently developed by Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd., with Chinese and international patent authorization, targeting B7-H3.TX103 has shown promising safety and efficacy signals in early clinical trials for the treatment of recurrent malignant glioma.Malignant gliomas are highly malignant, with GBM being the most common type. They are extremely prone to recurrence after surgery, and there are few effective treatments available upon recurrence, resulting in low survival rates and poor prognosis. There is a significant unmet medical need.B7-H3 is highly expressed in glioma tumor cells, serving as an immune checkpoint to help tumor cells evade immunity while conferring a more aggressive phenotype. Thus, high B7-H3 expression correlates with tumor invasiveness and poor prognosis.Due to the presence of the blood-brain barrier in the central nervous system and its status as an "immune-privileged area," it presents a significant challenge for drug treatment. CAR-T cells, as a living immunotherapy, offer unique advantages in the treatment of glioblastoma.

TX103 Successfully Approved for IND in China and the US, Marking a Significant Progress in Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd.'s CAR-T Cell Drug Development for Malignant Glioma Treatment in Both Countries.Next, we will comprehensively launch international multicenter clinical trials, hoping that this therapy can bring new treatment options to patients as soon as possible and provide more survival benefits.

About Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd.

Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. is a clinical-stage innovative biopharmaceutical company focused on developing T-cell immunotherapy products, co-founded by Professor Chen Lieping, a pioneer in tumor immunology, and Professor Huang Gangxiong, an expert in immune cell therapy.The company takes research and development innovation as its mission, focusing on developing innovative technologies and drugs for tumor immunology and immune cell therapy. It has built a professional team covering the entire drug development process, including scientific research, technology development, quality management, production processes and registration, and clinical research.Led by Professor Chen Ping, the Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. team is dedicated to developing globally innovative immunotherapy drugs to address unmet medical needs, bringing new hope to more cancer patients.

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