First in Human Administration of UCART123 in Cellectis’ AML Phase I Clinical Trial at Weill Cornell Medicine, NewYork-Presb...
28 June 2017 - 6:30AM
Business Wire
UCART123 is the First U.S. Gene Edited,
Off-the-Shelf CAR T-Cell Program
Regulatory News:
Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage
biopharmaceutical company focused on developing immunotherapies
based on gene-edited CAR T-cells (UCART), announced today the first
administration in the Phase I clinical study in Acute Myeloid
Leukemia (AML) for its investigational product UCART123, one of the
Company’s wholly-controlled TALEN® gene-edited product candidates.
This marks the first allogeneic, “off-the-shelf” gene-edited CAR
T-cell product candidate targeting CD123 to be investigated in
clinical trials.
This clinical research in AML is led by Principal Investigator
Dr. Gail J. Roboz, Professor of Medicine at Weill Cornell Medicine
and Director of the Clinical and Translational Leukemia Programs at
Weill Cornell Medicine and NewYork-Presbyterian Hospital.
The clinical trial will investigate the safety and efficacy of
UCART123 in patients with AML. AML is a devastating clonal
hematopoietic stem cell neoplasm which is characterized by
uncontrolled proliferation and accumulation of leukemic blasts in
bone marrow, peripheral blood and, occasionally, in other tissues.
These cells disrupt normal hematopoiesis and rapidly cause bone
marrow failure. In the U.S., there are an estimated 19,950 new AML
cases per year, with 10,430 estimated deaths per year. While
complete response rates can be as high as 80 percent in younger
patients who undergo initial induction cytotoxic chemotherapy, the
majority of AML patients relapse and die from the disease. AML
patients with high-risk genetic features have an especially urgent
unmet medical need, as their outcomes are dismal with all existing
treatment modalities, including allogeneic stem cell
transplantation.
“After being granted rapid approval from Regulatory Authorities
and Institutional Review Boards to initiate UCART123 studies, the
enrollment and treatment of the first patient represents a major
milestone for Cellectis, and we are eager to hit the ground running
with the recruitment of our first patient for our second UCART123
Phase I study in BPDCN soon,” said Dr. Loan Hoang-Sayag, Cellectis
Chief Medical Officer. “This first program targeting CD123 will be
a paradigm shift for our Company, as it will provide a wealth of
valuable additional knowledge and data to drive our gene-edited
allogeneic CAR T-cell platform.”
“We are excited to be enrolling our first patient with UCART123
and are hopeful that this novel immunotherapy modality will prove
to be a significant and effective weapon against AML,” said Dr.
Roboz.
The clinical trial is part of a strategic translational research
alliance that was formed between Cellectis and Weill Cornell
Medicine in 2015. Dr. Monica Guzman, an associate professor of
pharmacology in medicine at Weill Cornell Medicine, is co-principal
investigator whose work focuses on preclinical and early-stage
testing to optimize the development of stem cell-targeted cancer
drugs.
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.
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 maintaining regulatory approval to pursue
UCART123 clinical trials, the risk of not obtaining regulatory
approvals to commence clinical studies on UCART123 in other
countries or on other 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/20170627006309/en/
Media:Jennifer 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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