Full Press Release Details
and Pfizer Announce Preliminary Results of the First-in-Human Trials of
UCART19 Will Be Presented at the 59th
American Society of Hematology (ASH) Annual Meeting
NEW YORK--(BUSINESS WIRE)--November 1, 2017--Regulatory News:
Servier, Pfizer Inc. (NYSE: PFE) and Cellectis
(Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS), today
announced that preliminary results from two phase 1 trials with UCART19,
the allogeneic anti-CD19 CAR T-cell product being developed by Servier
and Pfizer, will be presented during the 59th American Society of
Hematology (ASH) Annual Meeting and Exposition to be held in Atlanta on
Results from the CALM (UCART19 in Advanced Lymphoid Malignancies)
study will be shared as an oral presentation by Reuben Benjamin,
principal investigator and consultant hematologist at King's College
Hospital, United Kingdom, on December 11 at 7.15 pm (EST). The CALM
study 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 study was initiated in the UK in August 2016.
The abstract for this presentation is available on the ASH website: https://ash.confex.com/ash/2017/webprogram/Paper100804.html
The PALL (Pediatric Acute Lymphoblastic Leukemia)
study is a phase 1, open label, study to evaluate the safety and the
ability of UCART19 to induce molecular remission in pediatric patients
with relapsed or refractory B-ALL. PALL was initiated in the UK in June
2016. Waseem Qasim, principal investigator of the PALL study and
consultant in pediatric immunology and reader in cell and gene therapy
at Great Ormond Street Hospital for Children, United Kingdom, will
present results from the trial during a poster session on December 9
from 5.30 pm to 7.30 pm.
The abstract for this presentation is available on the ASH website: https://ash.confex.com/ash/2017/webprogram/Paper100183.html
Servier is a sponsor of both studies. In 2015, Servier acquired
exclusive rights from Cellectis for UCART19, which is being codeveloped
by Servier and Pfizer.
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 France (Suresnes). With
a strong international presence in 148 countries and a turnover of 4
billion euros in 2016, Servier employs 21 000 people worldwide. Entirely
independent, the Group reinvests 25% of its turnover (excluding generic
drugs) in research and development and uses all its profits for
development. Corporate growth is driven by Servier's constant search for
innovation in five areas of excellence: cardiovascular,
immune-inflammatory and neuropsychiatric diseases, cancers and diabetes,
as well as by its activities in high-quality generic drugs.
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
Pfizer Inc.: Working together for a healthier world
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to people that extend and significantly improve their lives. We strive
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PFIZER DISCLOSURE NOTICE
The information contained in this release is as of 1 November 2017.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future
events or developments.
This release contains forward-looking information about a product
candidate, UCART19, including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical study commencement and completion
dates as well as the possibility of unfavorable study results, including
unfavorable new clinical data and additional analyses of existing
clinical data; [risks associated with preliminary data;] whether and
when drug applications may be filed for UCART19 in any jurisdiction;