Servier and Pfizer Announce Preliminary Results of the First-in-Human Trials of UCART19 Will Be Presented at
the 59 th American Society of Hematology (ASH) Annual Meeting
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 December 9-12.
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.
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 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 ®
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 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; 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 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.
Servier
Corporate Communications Department
Karine Bousseau
External Communications
+33 1 5572 6037
+33 6 4992 1605
media@servier.com
or
Pfizer
Media
Sally Beatty
Media Relations
+1 212-733-6566
Sally.Beatty@pfizer.com
or
Investors
Ryan Crowe
Investor Relations
+1 212-733-8160
Ryan.Crowe@pfizer.com
or
Cellectis
Media:
Jennifer Moore
VP of Communications
917-580-1088
media@cellectis.com
or
Caitlin Kasunich
KCSA Strategic Communications
212-896-1241
ckasunich@kcsa.com
or
IR:
Simon Harnest
VP of Corporate Strategy and Finance
646-385-9008
simon.harnest@cellectis.com
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