Tcelltech CAR-T Cell Therapy Recognized by FDA Orphan Drug (ODD)

On June 21, 2023, Tcelltech Biotech’s B7-H3 targeted CAR-T cell therapy product, It has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) Office of Orphan Drug Development for the treatment of malignant glioblastoma. According to the FDA Orphan Drug Act, orphan drug status will enjoy several preferential policies, including FDA support for clinical research guidance, exemption of NDA application fees, fast track for marketing application in the United States, and seven years of exclusive rights in the United States market after approval.

B7-H3 CAR-T cell products of Tcelltech:

The B7-H3 targeted CAR-T cells originally developed by Tcelltech is a product that has been in the phase I clinical trial stage. It has complete independent intellectual property rights, has obtained the Chinese invention patent authorization, and has entered the international patent national stage.

Tcelltech has the world’s leading application and layout in the development of CAR-T cell products targeting B7-H3 for a variety of tumors; Among them, for malignant glioblastoma, excellent safety and clinical efficacy have been initially demonstrated in patients with recurrent glioblastoma (GBM).

Malignant glioblastoma are highly malignant and have a poor prognosis. Among them, GBM is the most common, with a median survival time of 14.6 months after diagnosis and a 5-year survival rate of 4.7%. Moreover, GBM is prone to relapse after surgery, and there is a lack of effective treatment after recurrence, so new treatment techniques are urgently needed. The FDA orphan drug designation of Tcelltech B7-H3 CAR-T cells will play a positive role in accelerating the clinical program of the company’s products in China and the United States.

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.