FDA gives Servier's UCART19 therapy IND clearance

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.”