Full Press Release Details
Servier and Pfizer Announce Results of UCART19 First-in-Human Trials to
Be Presented at the 44th
Society for Blood and Marrow Transplantation) Annual
NEW YORK--(BUSINESS WIRE)--March 8, 2018--Regulatory News:
Servier, Pfizer Inc. (NYSE: PFE) and Cellectis (Paris:ALCLS)
(NASDAQ:CLLS) (Euronext Growth: ALCLS - Nasdaq: CLLS), today announced
that results from the 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 European society for Blood and Marrow
Transplantation (EBMT) Annual Meeting to be held from March 18 to 21,
2018 in Lisbon, Portugal.
Results from the CALM (UCART19 in Advanced Lymphoid Malignancies)
study will be presented during an oral session by Reuben Benjamin, MD,
PhD, Principal Investigator and consultant hematologist at King's
College Hospital, London, United Kingdom, on March 21, 2018 at 9:30 am
(Room 5A). The CALM study is an open label, dose-escalation study
designed to evaluate safety, tolerability and antileukemic activity of
UCART19 in adult patients with relapsed or refractory CD19-positive
B-cell acute lymphoblastic leukemia (B-ALL).
Presentation title: First-in-human study with UCART19, an allogeneic
anti-CD19 car T-cell product, in high-risk adult patients with CD19+ R/R
B-cell ALL: preliminary results of CALM study1
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. Paul Veys, MD, PhD, Director of the Bone Marrow Transplant Unit at
Great Ormond Street Hospital (GOSH), London, United Kingdom, will share
data during an oral session on March 21, 2018 at 11:40 am (Auditorium
Presentation title: Gene-edited allogeneic CAR19 T-cells (UCART19)
induce molecular remission ahead of allo-sct in high risk pediatric
patients with CD19+ relapsed/refractory B-cell Acute Lymphoblastic
Servier is the sponsor of both studies. In 2015, Servier acquired
exclusive rights from Cellectis for UCART19, which is being codeveloped
by Servier and Pfizer.
1 & 2 Abstracts are available on the EBMT
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 4.152
billion euros in 2017, Servier employs 21,600 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, cancer and diabetes,
as well as by its activities in high-quality generic drugs.
More information: www.servier.com
Pfizer Inc.: Working together for a healthier world
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com. In addition, to learn
at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook
at Facebook.com/Pfizer.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of March 7, 2018.
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 trial commencement and completion dates and
regulatory submission dates, as well as the possibility of unfavorable
study results, including unfavorable new clinical data and additional
analyses of existing clinical data; whether and when drug applications
may be filed for UCART19 with regulatory authorities in any
jurisdiction; whether and when any such applications may be approved by
regulatory authorities, which will depend on the assessment by such
regulatory authorities of the benefit-risk profile suggested by the