Tcelltech CAR-T Cells Approved by FDA

On September 30, 2023, TX103 CAR-T cell IND from Tcelltech Tiantan Biotech Co., Ltd. and its US Tcelltech company received tacit approval from the US Food and Drug Administration (FDA) for the treatment of malignant glioblastoma.

TX103, a B7-H3 targeted CAR-T cell drug, has shown excellent safety and efficacy signals in early clinical trials for the treatment of recurrent malignant glioblastoma. Malignant glioblastoma have a high degree of malignancy, among which GBM is the most common. It is easy to relapse after surgery, and there is a lack of effective treatment after recurrence. Since the central nervous system has a blood-brain barrier and is an “immune-exempt zone”, which is an important challenge for drug therapy, CAR-T cells as a living immune cell drug have special advantages in the treatment of glioblastoma. After the approval of TX103 IND, the company will make full efforts to promote international multi-center clinical trials, and strive to bring effective immune cell therapy drugs to patients with malignant glioblastoma as soon as possible.

TX103 product of Tcelltech has obtained Chinese invention patent and international patent authorization. In addition, this product has been granted orphan drug designation by the FDA for the treatment of malignant glioblastoma in June this year. This FDA clinical trial approval is an important milestone in the company’s layout of solid tumor treatment and promotion of internationalization.

Tcelltech is an innovative biomedical company in clinical stage, focusing on the development of T cell immune products. It was co-founded by Professor Chen Liping, a pioneer in tumor immunology, and Professor Huang Gangxiong, an expert in immune cell therapy. With the mission of research and innovation, the company focuses on the development of innovative technologies and drugs for tumor immunity and immune cell therapy, and has established a professional team covering the whole drug development process of scientific research, technology development, quality management, production process and registration, and clinical research.

Under the leadership of Professor Chen Liping, the team of Tcelltech is committed to developing global innovative immunotherapy drugs to bring new hope to more cancer patients in the face of unmet medical needs.

Gangxiong Huang, MD

Co-founder, CEO

Dr. Huang’s research has focused on tumor metastasis and T-cell immunotherapy. He completed his postdoctoral training and subsequently served as a researcher at The University of Texas MD Anderson Cancer Center. He also served as a pathologist and Minjiang Scholar Professor at Fujian Medical University previously.

Lieping Chen, MD, PhD​

Co-founder, Scientific advisor

Dr. Chen is a pioneer in cancer immunotherapy. His research focuses on fundamental T-cell biology and the translation of scientific discoveries into clinical therapies, with a primary emphasis on cancer immunotherapy. He discovered PD-L1 and established its role in tumor immune evasion, laying the foundation for anti-PD-1/PD-L1 therapies that have transformed cancer treatment worldwide. Among his other numerous discoveries, B7-H3 has emerged as a promising universal therapeutic target for solid tumors. 

Dr. Chen is United Technologies Corporation Professor in Cancer Research and Professor of Immunobiology, of Dermatology and of Medicine at Yale University. He held faculty positions at the Mayo Clinic, Johns Hopkins University, and scientist positions in the Bristol-Myers Squibb Co. before joining Yale University. Dr. Chen is a member of the National Academy of Sciences, the National Academy of Medicine, and a Fellow of the American Association for Cancer Research.