Cellectis Announces Successful cGMP Manufacturing for Second Product Candidate: UCART123
November 15 2016 - 5:00PM
Business Wire
Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq:
CLLS), a biopharmaceutical company focused on developing
immunotherapies based on gene edited CAR T-cells (UCART), today
announced that a series of production runs of UCART123, a Company’s
wholly-owned TALEN® gene edited product candidate, was successfully
performed in large scale, according to cGMP standards, for the
purpose of conducting two Phase 1 clinical trials in patients with
acute myeloid leukemia (AML) and blastic plasmacytoid dendritic
cell neoplasm (BPDCN).
The cGMP manufacturing of UCART123 clinical batches has been
operated with CELLforCURE, a LFB group company and the largest
industrial facility for clinical and commercial production of
innovative cell and gene therapies in Europe. CELLforCURE is in
charge of implementing cGMP manufacturing processes that are
designed and developed by Cellectis.
The manufacturing process for Cellectis’ allogeneic CAR T-cell
product line, Universal CARTs or UCARTs, yields frozen,
off-the-shelf, engineered CAR T-cells. UCARTs are meant to be
readily available CAR T-cells for a large patient population. Their
production can be industrialized and standardized with defined
pharmaceutical release criteria.
UCART123 is an engineered T-cell product candidate that targets
CD123, an antigen that is located on CD123-expressing leukemic
cells in AML as well as leukemic and other tumoral cells in BPDCN.
We are planning to file an Investigational New Drug application
(IND) with the United States Food and Drug Administration (FDA) in
order to initiate clinical studies.
AML is a devastating clonal hematopoietic stem cell neoplasm
characterized by uncontrolled proliferation and accumulation of
leukemic blasts in the bone marrow, peripheral blood, and
occasionally in other tissues. These cells disrupt normal
hematopoiesis and rapidly cause bone marrow failure and death. In
the U.S. alone, there are an estimated 19,950 new AML cases per
year, with 10,430 estimated deaths per year.
Preclinical and translational activities on UCART123 in AML are
performed in collaboration with Dr. Monica Guzman, Associate
Professor of Pharmacology in Medicine at Weill Cornell Medical
College. The clinical research at Weill Cornell will be led by
principal investigator Dr. Gail J. Roboz, Director of the Clinical
and Translational Leukemia Programs and Professor of Medicine.
BPDCN is a very rare and aggressive hematological malignancy
that is derived from plasmacytoid dendritic cell precursors. BPDCN
is primarily a disease of the bone marrow and blood cells, but also
often affects skin and lymph nodes.
Cellectis collaborates with the MD Anderson Cancer Center on the
preclinical development of UCART123 in BPDCN preliminary to the
Phase I clinical trial in BPDCN to be activated. The UCART123
clinical program at MD Anderson will be led by Professor Hagop
Kantarjian, MD, Department Chair, Department of Leukemia, Division
of Cancer Medicine.
“We are proud of achieving this important milestone for
UCART123, our first wholly owned product candidate. The successful
translation of an R&D concept into a cGMP clinical grade
industrial product is one of the key gating factors for us to move
into clinical trials,” said Arjan Roozen, Vice President, GMP
Solutions and Manufacturing.
“With this work and Cellectis’ breakthrough TALEN®-based gene
editing technology, we continue building upon the Company’s
milestones as a pioneer in the field, strengthening our pipeline
and bringing us closer and closer to finding efficient and
cost-effective products for cancer patients across the globe,”
added David J.D. Sourdive, Executive Vice President, Corporate
Development, Cellectis.
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
16 years of expertise in genome engineering - based on its flagship
TALEN® products and meganucleases and 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.
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/20161115006730/en/
For further information, please contact:Media
contacts:CellectisJennifer Moore, 917-580-1088VP of
Communicationsmedia@cellectis.comorKCSA Strategic
CommunicationsCaitlin Kasunich,
212-896-1241ckasunich@kcsa.comorIR contact:CellectisSimon
Harnest, 646-385-9008VP of Corporate Strategy and
Financesimon.harnest@cellectis.com
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