First Patient Dosed with Cellectis’ New Allogeneic UCART123 Product Candidate for Relapsed/Refractory Acute Myeloid Leukemia
January 15 2020 - 3:30PM
Business Wire
AMELI-01 Clinical Trial Uses New UCART123
Construct With Optimized Production Process & New IND
Number
First Patient Dosed at MD Anderson Cancer
Center
Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS -
Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused
on developing immunotherapies based on gene-edited allogeneic CAR
T-cells (UCART), announced today the first patient dosing in
AMELI-01, the Phase 1 dose escalation clinical trial evaluating a
new UCART123 product candidate in relapsed/refractory acute myeloid
leukemia (AML). This trial, sponsored by Cellectis, is part of an
Investigational New Drug (IND) from the US Food and Drug
Administration for a new UCART123 construct and an optimized
production process, and will evaluate the safety, expansion,
persistence and clinical activity of the product candidate in
patients with relapsed/refractory AML. AMELI-01 replaces the first
US clinical trial assessing the UCART123 product candidate.
“Cellectis invented and has pioneered the allogeneic approach
for many years,” said Dr. André Choulika, Chairman and CEO,
Cellectis. “Being a leader of the space, it’s important for us to
consistently improve our technology and manufacturing expertise to
remain at the forefront. With this new IND, we are delivering on
our promise of continual innovation in order to advance the efforts
of our clinical trials. We hope that with this optimized production
process, our UCART123 product candidate will be well equipped to
help people living with AML.”
This clinical trial is led by Gail J. Roboz, M.D., Professor of
Medicine at Weill Cornell Medicine and New York-Presbyterian (New
York, USA), in collaboration with Naveen Pemmaraju, M.D., Associate
Professor, Department of Leukemia, Division of Cancer Medicine at
The University of Texas MD Anderson Cancer Center (Texas, USA),
David Sallman, M.D., Assistant Member in the Malignant Hematology
Department at H. Lee Moffitt Cancer Center (Florida, USA), and
Daniel DeAngelo, M.D., Ph.D., Institute Physician and Director of
Clinical and Translational Research of Adult Leukemia at Dana
Farber Cancer Institute (Massachusetts, USA).
About UCART123
Our wholly controlled product candidate, UCART123, is a
gene-edited T-cell investigational drug that targets CD123, an
antigen expressed at the surface of leukemic cells in AML. In July
2019, the US Food and Drug Administration (FDA) accepted an
Investigational New Drug (IND) for Cellectis to conduct a Phase 1
clinical trial with an optimized version of the UCART123 product
candidate in patients living with AML. This IND includes a new
UCART123 construct and an optimized production process, and
replaces our previous IND on UCART123.
About Cellectis
Cellectis is developing the first of its kind allogeneic
approach for CAR-T immunotherapies in oncology, pioneering the
concept of off-the-shelf and ready-to-use gene-edited CAR T-cells
to treat cancer patients. As a clinical-stage biopharmaceutical
company with over 20 years of expertise in gene editing, Cellectis
is developing life-changing product candidates utilizing TALEN®,
its gene editing technology, and PulseAgile, its pioneering
electroporation system to harness the power of the immune system in
order to target and eradicate cancer cells.
As part of its commitment to a cure, Cellectis remains dedicated
to its goal of providing life-saving UCART product candidates to
address unmet needs for multiple cancers including acute myeloid
leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL),
multiple myeloma (MM), Hodgkin lymphoma (HL) and non-Hodgkin
lymphoma (NHL).
Cellectis headquarters are in Paris, France, with additional
locations in New York, New York and Raleigh, North Carolina.
Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and
on Euronext Growth (ticker: ALCLS). For more information, visit
www.cellectis.com.
Follow Cellectis on social media: @cellectis, LinkedIn and
YouTube.
TALEN® is a registered trademark owned by 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 risk
factors that may affect company business and financial performance
is included in Cellectis’ Annual Report on Form 20-F and the
financial report (including the management report) for the year
ended December 31, 2018 and subsequent filings Cellectis makes with
the Securities Exchange Commission from time to time. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons why
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: https://www.businesswire.com/news/home/20200115005813/en/
For further information, please contact:
Media contacts: Jennifer Moore, VP of Communications,
917-580-1088, media@cellectis.com Caitlin Kasunich, KCSA Strategic
Communications, 212-896-1241, ckasunich@kcsa.com
IR contact: Simon Harnest, VP of Corporate Strategy and
Finance, 646-385-9008, simon.harnest@cellectis.com
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