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Servier 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
1 November 2017 – Servier, Pfizer Inc. (NYSE: PFE) and Cellectis (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.
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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.
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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; 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.
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.
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.