Servier and Pfizer announce FDA clearance of IND application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

Published on March 09, 2017 in New-York, New-York (USA)

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9 March 2017 – Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational New Drug (IND) clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.

Servier is sponsoring the CALM Phase 1 study on UCART19. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

The CALM study was initiated in the UK in August 2016. CALM is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The allogeneic UCART19 candidate and CALM protocol were reviewed at the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) meeting on December 14, 2016. Servier submitted an IND application on February 1, 2017, with Pfizer’s support. With this IND clearance, the CALM study will be expanded to include several centers in the U.S., including the MD Anderson Cancer Center in Houston (Texas).

“We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR T therapy”, said Dr Patrick Thérasse, Director of Clinical Development Oncology at Servier. “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 is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies,” said Barbara Sasu, Vice President, CAR T Research at Pfizer. “We are looking forward to having the opportunity to investigate this approach in the U.S.”

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.