China-based Juventas Cell Therapy Ltd’s chimeric antigen receptor (CAR) T-cell therapy, CNCT19 (Inaticabtagene Autoleucel), has obtained Investigational New Drug (IND) approval from the US FDA for the treatment of recurrent or refractory B-cell acute lymphocytic leukemia (r/r B-ALL).
Previous Approvals and Status
CNCT19, a CD19-targeted CAR-T therapy, has previously earned IND approvals for R/R B-cell non-Hodgkin’s lymphoma, R/R acute lymphocytic leukemia, and R/R B-cell acute lymphoblastic leukemia. The drug has also received breakthrough therapy status in China and orphan drug designation (ODD) in the United States. A new drug application (NDA) filing for CNCT19 in R/R B-cell acute lymphoblastic leukemia has been accepted for review by the National Medical Products Administration (NMPA) with priority review status.
Market Context
Fosun Kite Bio’s Yescarta (axicabtagene ciloleucel) became the first CD19-targeted CAR-T therapy to win market approval in China in June 2021. It is used to treat relapsed or refractory large B-cell lymphoma after previous systemic treatment. JW Therapeutics’s (HKEx: 2126) Carteyva (relmacabtagene autoleucel injection) became the second CD19-targeted CAR-T therapy approved in China in September 2021. Meanwhile, Legend Bio’s BCMA CAR-T is awaiting regulatory decisions from the NMPA.
Significance of the IND Approval
The FDA’s IND approval for CNCT19 marks a significant milestone for Juventas Cell Therapy, allowing the company to proceed with clinical trials in the United States. This approval highlights the potential of CNCT19 to offer new treatment options for patients with r/r B-ALL and further solidifies Juventas’s position in the growing CAR-T therapy market.-Fineline Info & Tech
