Cellectis Publishes Two Articles in Nature
Communications Providing Strong Preclinical Validation of
UCART123 to Treat AML and BPDCN
Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS),
a clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies, announced the publication of two manuscripts in
Nature Communications on its product
candidate UCART123, currently being evaluated in the Phase 1
dose-escalation trial AMELI-01 in patients with relapsed or
refractory acute myeloid leukemia (r/r AML). These preclinical data
demonstrate the robust in vitro and in vivo activity of UCART123
and provide pre-clinical proof of concept for an allogenic CART
cell approach to tackle AML.
Allogeneic TCRαβ Deficient CAR T-cells
Targeting CD123 in Acute Myeloid Leukemia
This preclinical study, led by Dr Monica Guzman,
Ph.D., Division of Hematology and Oncology, Department of Medicine
Weill Cornell Medical College, demonstrated that Cellectis’ product
candidate UCART123 effectively eliminates AML cells in vitro and in
vivo with improvements in overall survival and minimal impact
against normal hematopoietic progenitors.
AML is a disease originated and maintained from
leukemia stem cells (LSCs). CD123 is a cell surface antigen
expressed on AML blasts as well as LSCs. In this study, the
potential of allogeneic gene-edited CAR T cells targeting CD123 to
eliminate LSCs (UCART123) was evaluated.
“While the majority of the few CD123 T-cell
therapies evaluated to date rely on autologous approaches with
complex clinical and logistical barriers, this set of preclinical
results strongly supports the potential benefits of the allogeneic
CAR T approach in AML. UCART123 exhibits unprecedented primary
AML-selective cytotoxic activity and minimal effects against normal
cells, which was a major drawback reported in previous preclinical
studies performed with other CD123 targeted CARs” said Mark
Frattini, MD, Ph.D., Senior Vice President, Head of Clinical
Sciences at Cellectis.
Preclinical results showed that:
- UCART123 demonstrates cytotoxic activity against primary AML
samples with minimum toxicity against normal hematopoietic
progenitor cells
- UCART123 targets AML cells in vivo and results in improved
overall survival in patient-derived xenografts (PDX)
models
- UCART123 selectively clears primary AML cells, without
affecting hematopoiesis, in a competitive humanized mouse model
harboring primary AML and normal bone marrow cells
Targeting CD123 in Blastic Plasmacytoid
Dendritic Cell Neoplasm using Allogeneic Anti-CD123 CAR T
Cells
This preclinical study, led by Professor Marina
Konopleva, M.D., Ph.D., Department of Leukemia, University of Texas
MD Anderson Cancer Center, demonstrated the antitumor activity of
UCART123 in preclinical models of blastic plasmacytoid dendritic
cell neoplasm (BPDCN).
BPDCN is a rare hematologic malignancy with poor
outcomes with conventional therapy. Given that CD123 is
differentially expressed on the surface of BPDCN cells, it has
emerged as an attractive therapeutic target.
In this study, the antitumor activity of
allogeneic CD123 CAR T cells (UCART123) was demonstrated by in
vitro and in vivo assays using primary BPDCN samples.
Preclinical results showed that:
- UCART123 cells result in specific killing of BPDCN primary
samples in vitro and in xenograft (PDX) experiments in vivo
- Cytokine production levels in mice correlate with tumor burden
at the time of UCART123 administration
- Tumor relapse was observed upon loss of CD123, through diverse
genetic mechanism, in one of the PDX models
“These preclinical results support our rationale
of using allogeneic CD123 CAR T cells to treat AML. Cellectis’
UCART123 is the first allogeneic product candidate to demonstrate
elimination of AML and BPDCN cells in PDX mouse experiments, with
significant benefits in overall survival and low impact on
hematopoietic progenitor cells. This brings us one step closer to
delivering these innovative therapies to patients with unmet
medical needs” said Roman Galetto, Sr. Director Preclinical &
Program Management at Cellectis.
Cellectis’ AMELI-01 clinical study is currently
enrolling patients at Dose Level 2 (6.25 × 105 cells/kg) with
Fludarabine Cyclophosphamide and Alemtuzumab (FCA) preconditioning
regimen.
Articles are available on the Nature
Communications website, by clicking on the links below:
Allogeneic TCRαβ Deficient CAR T-cells Targeting
CD123 in Acute Myeloid Leukemia
Targeting CD123 in Blastic Plasmacytoid
Dendritic Cell Neoplasm using Allogeneic Anti-CD123 CAR T Cells
About Cellectis
Cellectis is a clinical-stage biotechnology
company using its pioneering gene-editing platform to develop
life-saving cell and gene therapies. Cellectis utilizes an
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, and a platform to
make therapeutic gene editing in hemopoietic stem cells for various
diseases. As a clinical-stage biopharmaceutical company with over
22 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 treat
diseases with unmet medical needs. Cellectis’ headquarters are in
Paris, France, with 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.
For further information, please
contact:
Media contacts: Pascalyne
Wilson, Director, Communications, +33 (0)7 76 99 14
33, media@cellectis.comMargaret Gandolfo, Senior Manager,
Communications, +1 (646) 628 0300
Investor Relation contact: Arthur Stril,
Chief Business Officer, +1 (347) 809 5980,
investors@cellectis.com Ashley R. Robinson, LifeSci Advisors,
+1 617 430 7577
Forward-looking Statements
This press release contains “forward-looking”
statements within the meaning of applicable securities laws,
including the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by words such as
“anticipate,” “believe,” “intend”, “expect,” “plan,” “scheduled,”
“could” and “will,” or the negative of these and similar
expressions. These forward-looking statements, which are based on
our management’s current expectations and assumptions and on
information currently available to management. Forward-looking
statements include statements about the meaning of the preclinical
results of our product candidates and the resulting outcome on our
clinical results. These forward-looking statements are made in
light of information currently available to us and are subject to
numerous risks and uncertainties, including with respect to the
numerous risks associated with biopharmaceutical product candidate
development. With respect to our cash runway, our operating plans,
including product development plans, may change as a result of
various factors, including factors currently unknown to us.
Furthermore, many other important factors, including those
described in our Annual Report on Form 20-F and the financial
report (including the management report) for the year ended
December 31, 2021 and subsequent filings Cellectis makes with the
Securities Exchange Commission from time to time, as well as other
known and unknown risks and uncertainties may adversely affect such
forward-looking statements and cause our actual results,
performance or achievements to be materially different from those
expressed or implied by the forward-looking statements. 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.
- UCART123_PR_ENGLISH_FINAL (1).pdf
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