TauNeo Therapeutics Announces FDA IND Clearance for B7-H3-Targeted CAR-T Therapy TX103 in Malignant Glioma
Tcelltech
Developer of Immuno-oncology and Cell Therapy Drugs
Tcelltech
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Recently, Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. and its U.S.-based Tcelltech company announced that the Investigational New Drug (IND) application for their TX103 CAR-T cell therapy has been approved by the FDA for the treatment of malignant glioblastoma. In June this year, TX103 received Orphan Drug Designation from the FDA.
It is understood that malignant gliomas are highly malignant, with GBM being the most common type. They are extremely prone to recurrence after surgery and lack effective treatment options upon recurrence, leading to low survival rates and poor prognosis, representing a significant unmet medical need. The central nervous system, due to the presence of the blood-brain barrier and being an "immune-privileged area," poses a major challenge for drug therapy. CAR-T cells, as a living immunotherapy, offer unique advantages in treating glioblastoma.
According to the introduction from Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd., TX103 is a CAR-T cell drug targeting B7-H3, which has shown promising safety and efficacy signals in early clinical trials for the treatment of recurrent malignant glioma. B7-H3 (also known as CD276) is a type I transmembrane protein that belongs to the B7 family of immune co-stimulatory and co-inhibitory molecules. It is expressed at low levels in normal human tissues but is abnormally highly expressed in various solid tumors such as pancreatic cancer, prostate cancer, ovarian cancer, lung cancer, clear cell renal carcinoma, osteosarcoma, Ewing's sarcoma, and neuroglioma.
Currently, multiple drugs targeting the B7-H3 have been developed globally, with drug types mainly including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and CAR-T therapies. In terms of indications, B7-H3 targeted drugs under research are primarily being developed for the treatment of solid tumors, including central nervous system tumors.
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