FDA gives Servier's UCART19 therapy IND clearance

Servier is sponsoring a UCART19 study titled CALM Phase 1 that began in the U.K. in August 2016.
Servier is sponsoring a UCART19 study titled CALM Phase 1 that began in the U.K. in August 2016. | File photo
The U.S. Food and Drug Administration recently issued Investigational New Drug clearance for Servier’s UCART19, allowing the company to proceed with clinical development of the allogeneic, gene-edited cellular therapy.
According to Servier, Pfizer and Cellectis, the therapy could be used to treat relapsed/refractory acute lymphoblastic leukemia. Servier acquired the rights for the therapy from Cellectis in 2015, and Servier and Pfizer are now co-developing it.
“Pfizer is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies,” Pfizer CAR T Research Vice President Barbara Sasu said. “We are looking forward to having the opportunity to investigate this approach in the U.S.”
Servier is sponsoring a UCART19 study titled CALM Phase 1 that began in the U.K. in August 2016 and is testing the thereapy in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
“We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR T therapy,” Servier Director of Clinical Development Oncology Dr. Patrick Thérasse said. “B-ALL is a devastating disease and this study is key to gaining greater insight into the efficacy and safety profile of this new immune-oncology approach in patients with B-ALL.”
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