The Center for Drug Evaluation (CDE) website indicates that PersonGen BioTherapeutics (Suzhou) Co., Ltd’s TAA06, an in-house developed chimeric antigen receptor (CAR)-T cell targeting B7-H3, has obtained tacit clinical trial approval for relapsed/refractory neuroblastoma. This approval signifies that the world’s first B7-H3 CAR-T therapy will enter the regulatory study phase.
Drug Profile
TAA06, PersonGen’s first CAR-T product for solid tumors, demonstrated excellent results in in vitro and in vivo pharmacodynamic studies and safety evaluations. The drug received orphan drug designation (ODD) and rare disease designation in the US in March 2022. On April 8, 2022, the CDE accepted its IND for review, marking it as the first of its kind globally to be reviewed by a drug regulator.
B7-H3 Target
B7-H3 (also known as CD276) is a type I transmembrane protein belonging to the B7 immune co-stimulatory and co-suppressive family. It is abnormally highly expressed in solid tumors such as carcinoma, lung cancer, clear cell renal carcinoma, osteosarcoma, Ewing sarcoma, and glioma. B7-H3 is also highly expressed in most types of pediatric solid tumors, including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, hepatoblastoma, Wilms tumor, and central nervous system tumors, indicating TAA06’s potential for treating solid tumors in children.
Company Background
PersonGen BioTherapeutics boasts autologous CAR-T, universal UCAR-gdT, and iPSC-NK technology platforms, along with a full-chain production system spanning from plasmids and lentiviruses to CAR-T cell preparation. Its CD7-CAR-T cell, developed for refractory relapsed T-cell and NK-cell malignancies, received regulatory study approval in China in August 2021 and ODD status in the US in November 2021.-Fineline Info & Tech
