Regulatory News:
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.”
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.
About Servier
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
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 healthcare
products. Our global portfolio includes medicines and vaccines, as
well as many of the world's best-known consumer healthcare
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, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter at
@Pfizer and @Pfizer_News, LinkedIn and like us on Facebook at
Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of 9 March 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 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; whether and when
drug applications may be filed for UCART19 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 totality of the efficacy and safety information submitted;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of UCART19; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About Cellectis
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).
To find out more about us, visit our website:
www.cellectis.com
Talking about gene editing? We do it. TALEN® is a registered
trademark owned by the Cellectis Group.
Cellectis Disclaimer
This press release contains “forward-looking” statements that
are based on our management’s current expectations and assumptions
and on information currently available to management.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. The risks and uncertainties
include, but are not limited to, the risk that the preliminary
results from our product candidates will not continue or be
repeated, the risk of not obtaining regulatory approval to commence
clinical trials on the UCART product candidates, the risk that any
one or more of our product candidates will not be successfully
developed and commercialized. Further information on the risks
factors that may affect company business and financial performance,
is included in filings Cellectis makes with the Security Exchange
Commission from time to time and its financial reports. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
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version on businesswire.com: http://www.businesswire.com/news/home/20170308006495/en/
ServierKarine Bousseau, +33 1 5572 6037Servier External
Communicationsmedia@servier.comorPfizer IncMedia
RelationsSally Beatty, +1 (212) 733-6566orInvestor RelationsRyan
Crowe, +1 (212) 733-8160orMediaCellectisJennifer
Moore, 917-580-1088VP of Communicationsmedia@cellectis.comorKCSA
Strategic CommunicationsCaitlin Kasunich,
212-896-1241ckasunich@kcsa.comorIR:Simon Harnest,
646-385-9008VP of Corporate Strategy and
Financesimon.harnest@cellectis.com
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