Regulatory News:
Servier, Pfizer Inc. (NYSE: PFE) and Cellectis
(Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS - Nasdaq:
CLLS) presented at the 59th American Society of Hematology (ASH)
Annual Meeting and Exposition in Atlanta preliminary results from
two phase 1 studies of UCART19, an investigational allogeneic
anti-CD19 CAR T-cell product, in adult and pediatric patients with
relapsed or refractory (R/R) CD19-positive B-cell acute
lymphoblastic leukemia (B-ALL). These first-in-human data
demonstrated the safety and tolerability of UCART19, resulting in
an 83% complete remission rate across the adult and pediatric
patient population.
Results from the CALM (UCART19 in Advanced
Lymphoid Malignancies) Trial
The CALM study (UCART19 in Advanced
Lymphoid Malignancies) is an open label,
dose-escalation study designed to evaluate the safety, tolerability
and anti-leukemic activity of UCART19 in adult patients with R/R
B-ALL. Five out seven patients treated achieved molecular remission
at Day 28 post UCAR19. Molecular remission is defined by negative
minimal residual disease (MRD). MRD is a measurement of the number
of residual leukemic cells that remain after treatment.
“These early results for UCART19 are very encouraging both in
terms of manageable safety and the impressive complete molecular
remission rate in these hard-to-treat adult patients with R/R
B-ALL,” said Reuben Benjamin, Principal Investigator of the CALM
Study and Consultant Hematologist at King’s College Hospital,
United Kingdom. “This first cohort explored a lower dose of UCART19
that is approximately one tenth of that used in most autologous
CAR-T trials. These results support additional evaluation of
UCART19 at varying doses.”
Only one Grade 1 cutaneous acute graft versus host disease
(GvHD) occurred. No severe neurotoxicity was observed. Cytokine
release syndromes (CRS) were mild and manageable except in one
patient treated with UCART19 at the first dose level, who developed
CRS Grade 4 and neutropenic sepsis leading to death at Day 15.
Results from the PALL (Pediatric Acute
Lymphoblastic Leukemia) Trial
The PALL (Pediatric Acute Lymphoblastic
Leukemia) study is a phase 1, open label study designed to
evaluate the safety and ability of UCART19 to induce molecular
remission defined by MRD negativity at Day 28 to enable allogeneic
stem cell transplantation in pediatric patients with high-risk R/R
B-ALL. Results showed all five children achieved MRD negativity,
enabling them to proceed to allogeneic stem cell transplant. Only
one Grade 1 cutaneous acute GvHD occurred. No severe neurotoxicity
was observed. Cytokine release syndromes were mild in the majority
of cases and were all manageable.
Servier is the sponsor of both studies that are active in Europe
and the United States.
“We are proud to present the first clinical trial data with
UCART19 in patients with heavily pretreated R/R ALL,” said Patrick
Therasse, MD, PhD, Head of Research and Development-Oncology for
Servier. “We believe this innovative, allogeneic CAR T-cell
approach could be disruptive to the patient community.”
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 adult and pediatric ALL and is currently in Phase I.
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 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: https://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 more, please visit us on www.pfizer.com and
follow us on Twitter 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 December 12,
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; the risk that clinical trial data
are subject to differing interpretations, and, even when we view
data as sufficient to support the safety and/or effectiveness of a
product candidate, regulatory authorities may not share our views
and may require additional data or may deny approval altogether;
whether regulatory authorities will be satisfied with the design of
and results from our clinical studies; 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, and, if
approved, whether UCART19 will be commercially successful;
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 clinical-stage biopharmaceutical company focused
on developing a new generation of cancer immunotherapies based on
gene-edited T-cells (UCART). By capitalizing on its 17 years of
expertise in gene editing – built on its flagship TALEN® technology
and pioneering electroporation system PulseAgile – Cellectis uses
the power of the immune system to target and eradicate cancer
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. 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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ServierMedia RelationsSonia
Marques, +33 (0)1 5572 4021 / +33 (0)7 8428
7613media@servier.comorKarine Bousseau, +33 (0)1 5572 6037 / +33
(0)6 4992 1605media@servier.comorPfizerPfizer MediaSally Beatty, +1 212-733-6566Media
RelationsSally.Beatty@pfizer.comorPfizer
InvestorsRyan Crowe, +1 212-733-8160Investor
RelationsRyan.Crowe@pfizer.comorCellectisMedia:Jennifer Moore, 917-580-1088VP of
Communicationsmedia@cellectis.comorCaitlin Kasunich,
212-896-1241KCSA Strategic
Communicationsckasunich@kcsa.comorIR:Simon Harnest, 646-385-9008VP of Corporate
Strategy and Financesimon.harnest@cellectis.com
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