Biosyngen's B7-H3-Targeted CAR-T Therapy TAA06 Receives FDA Orphan Drug Designation for Neuroblastoma

Source | Pharmaceutical Viewpoint

On March 20, Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD ("Bo Sheng Ji Medicine") announced that the company's developed B7-H3-targeted chimeric antigen receptor (CAR)-T cell injection (R&D code: TAA06 injection) has recently been granted Orphan Drug Designation by the U.S. FDA for the treatment of neuroblastoma.

The advent of CAR-T cell therapy is an important breakthrough in the field of cancer. Currently, multiple CAR-T cell therapy products have been approved worldwide, offering new options for many patients with blood cancers. However, in the field of solid tumor treatment, CAR-T cell therapy products have yet to achieve a breakthrough. According to the press release from Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD, the main reasons for the poor efficacy of CAR-T products in solid tumors are the heterogeneity of solid tumors, which can easily lead to treatment escape, and the obstruction of T-cell homing and infiltration by the tumor's immunosuppressive microenvironment.

Neuroblastoma is one of the most common extracranial solid tumors in children, characterized by its insidious onset and strong heterogeneity. Among them, high-risk neuroblastoma is known as the "king of pediatric cancers" due to its low cure rate. As neuroblastoma is a low-immunogenic tumor, the effect of immunotherapy has been consistently poor, and there is an urgent clinical need for new treatment methods.

To address the aforementioned challenges, the research and development team at Bo Sheng Ji Medicine has specifically developed TAA06 injection. This is a CAR-T cell injection targeting B7-H3. B7-H3 is a transmembrane protein in the B7 family, frequently overexpressed in various cancers including lung cancer, prostate cancer, and breast cancer. Moreover, its overexpression is associated with poor patient prognosis, making B7-H3 a notable target for cancer therapy.

According to the press release, Bo Shengji Medicine plans to develop TAA06 Injection for the treatment of neuroblastoma. In preclinical studies, this candidate drug has achieved good pharmacodynamic and safety data. In addition, Bo Shengji Medicine also stated in the press release that the company has successfully developed a highly optimized fully automatic preparation process, which can effectively control the cost of the product and create conditions for improving the accessibility of innovative CAR-T cell drugs for ordinary children. The granting of orphan drug designation by the FDA this time is an important research progress for TAA06 Injection.

Note: Content has been abridged.

Original Title: Bo Shengji Medicine's CAR-T Product Receives FDA Orphan Drug Designation for Neuroblastoma!

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