Cellectis’ UCART123 Administered to First Patient with BPDCN in Phase I Clinical Trial at MD Anderson Cancer Center
August 17 2017 - 4:30PM
Business Wire
UCART123 is First U.S. Gene Edited,
Off-the-Shelf CAR T-Cell Program
Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS)
(Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage
biopharmaceutical company focused on developing immunotherapies
based on gene-edited CAR T-cells (UCART), announced today that the
first patient with Blastic Plasmacytoid Dendritic Cell Neoplasm
(BPDCN) has been dosed in Cellectis’ Phase I clinical study using
the Company’s wholly controlled TALEN® gene edited product
candidate UCART123 at the MD Anderson Cancer Center. UCART123 is
the first allogeneic, “off-the-shelf” gene edited CAR T-cell
product candidate targeting CD123 to be investigated in U.S.
clinical trials.
The UCART123 clinical program for BPDCN is led by Dr. Naveen
Pemmaraju, MD, Assistant Professor, Professor Marina Konopleva MD,
PhD, and Professor Hagop Kantarjian, MD, Department Chair,
Department of Leukemia, Division of Cancer Medicine, at the MD
Anderson Cancer Center.
The clinical trial will investigate the safety and efficacy of
UCART123 in patients with BPDCN in the relapsed, refractory and
front-line setting. BPDCN is a rare and aggressive hematological
malignancy classified in the myeloid diseases among the acute
leukemias that are derived from plasmacytoid dendritic cell
precursors. It is a bone marrow disease that also often affects
skin and lymph nodes.
Given its rarity and recent recognition as a distinct
clinicopathological entity, no standardized therapeutic approach
has been established for BPDCN, and the optimal therapy remains to
be defined. Although transient responses are achieved by
combination chemotherapy regimens that are used to treat acute
leukemia or lymphoma, most patients relapse with the drug-resistant
disease.
“We are eager to progress through clinical trials with UCART123,
Cellectis’ wholly controlled gene-edited product candidate, next
with the treatment of BPDCN, rare but aggressive entity,” said Dr.
Loan Hoang-Sayag, Cellectis’ Chief Medical Officer. “With this
innovative treatment, the hope is that our “off-the-shelf” approach
will transform the way we think about cancer care and serve as the
next step in curing this disease through the power of gene
editing.”
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/20170817005965/en/
CellectisMedia:Jennifer Moore, 917-580-1088VP of
Communicationsmedia@cellectis.comorCaitlin Kasunich,
212-896-1241KCSA Strategic
Communicationsckasunich@kcsa.comorIR:Simon Harnest,
646-385-9008VP of Corporate Strategy and
Financesimon.harnest@cellectis.com
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