Regulatory Affairs

Pfizer, Servier get FDA nod to start US testing of UCART19

PBR Staff Writer Published 10 March 2017

Servier and Pfizer have secured clearance from the US Food and Drug Administration (FDA) to go ahead with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.

Servier, which took the responsibility of the CALM Phase 1 study, purchased exclusive rights of UCART19 from Cellectis in 2015. 

Last August, the CALM study was started in the UK, which is an open label and dose-escalation trial that will assess safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The IND clearance will allow to expand the CALM study to several centers, including the MD Anderson Cancer Center in Houston (Texas).

The UCART19 is an allogeneic CAR T-cell product candidate that is being developed to treat CD19-expressing hematological malignancies and gene edited with Talen.

Initially, the UCART19 is being developed in acute lymphoblastic leukemia (ALL). It is currently in Phase I study.

According to Pfizer, the current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology.

Pfizer has secured exclusive rights from Servier to develop and market UCART19 in the US, while Servier holds exclusive rights for all other countries.

Servier clinical development oncology director 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.”

Pfizer’s CAR T research vice president Barbara Sasu said: “Pfizer is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies.”

Image: Pfizer world headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.