Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia
- Category: DNA RNA and Cells
- Published on Thursday, 09 March 2017 19:27
- Hits: 1331
NEW YORK, NY, USA I March 9, 2017 I Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (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.”
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.
Servier is an international pharmaceutical company governed by a non-profit foundation with its headquarters in Suresnes (France). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21 000 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular diseases, diabetes, cancers, immune-inflammatory diseases, and neurodegenerative diseases, as well as by its activities in high-quality generic drugs. Being completely independent, the Group reinvests 25% of turnover (excluding generics) in research and development and uses all its profits for growth.
Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as various leukemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, targeted, immune and cellular therapies, to deliver life-changing medicines to patients.
More information: www.servier.com
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Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART). The company’s mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 17 years of expertise in genome engineering - based on its flagship TALEN® products and meganucleases as well as its pioneering electroporation PulseAgile technology - to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on cells.
Using its life-science-focused, pioneering genome-engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets. Cellectis is listed on the Nasdaq market (ticker: CLLS) and on the NYSE Alternext market (ticker: ALCLS).