Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the
“Company”), a gene-editing company with clinical-stage
immuno-oncology programs using allogeneic chimeric antigen receptor
(CAR)-T cells and gene therapy programs for genetic diseases, today
announced the release of two abstracts, which were accepted for
presentation at the 63rd American Society of Hematology (ASH)
Annual Meeting taking place from December 11-14, 2021. The Company
will present updated preliminary clinical data from its BALLI-01
clinical trial in patients with relapsed/refractory B-cell acute
lymphoblastic leukemia (B-ALL), and preclinical data for
TALGlobin01 for patients with HbSS Sickle Cell Disease (SCD).
“2021 has been a busy and productive year for
Cellectis, with our proprietary clinical and preclinical programs
making noteworthy progress. Cellectis is advancing one of the most
robust allogeneic CAR-T pipelines and we are excited to share
additional preliminary data from our BALLI-01 clinical trial, which
is evaluating UCART22, in patients with relapsed and refractory
B-cell acute lymphoblastic leukemia for whom there continues to be
an urgent need for safe and effective treatments. We are also proud
to disclose initial pre-clinical data from our .HEAL platform’s
product candidate, TALGlobin01, which demonstrates that
TALEN® could be specific and efficient at
correcting the mutated beta-globin gene, the underlying cause of
sickle cell disease,” said Carrie Brownstein, MD, Chief Medical
Officer at Cellectis.
Cellectis Poster
Presentations
BALLI-01 investigating UCART22 product
candidate in R/R B-ALL
The abstract includes updated preliminary data
from the Phase I, open-label, dose-escalation BALLI-01 study in
patients with R/R B-ALL from the first cohort of patients who
received UCART22 after FCA (fludarabine, cyclophosphamide and
alemtuzumab) lymphodepletion. The data show that the addition of
alemtuzumab to fludarabine and cyclophosphamide was well tolerated,
deepened host T-cell depletion and promoted CAR-T cell
expansion.
UCART22 is a novel and genetically modified allogeneic T-cell
product manufactured from healthy donor cells. T-cells are
transduced using a lentiviral vector to express the anti-CD22
chimeric antigen receptor (CAR) and are modified to disrupt the
T-cell receptor alpha constant (TRAC) and CD52 genes to minimize
risk of graft-vs-host disease (GvHD) and to allow use of
anti-CD52–directed drugs for lymphodepletion.
These data are encouraging and support the
continued enrollment into the study. Additional data will be
presented at the congress.
Poster Abstract Session:
Title: Preliminary Results from the
Flu/Cy/Alemtuzumab Arm of the Phase I BALLI-01 Trial of UCART22, an
Anti-CD22 Allogeneic CAR-T Cell Product, in Adult Patients with
Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic
Leukemia (B-ALL)
Abstract: #1746
Presenter: Jain Nitin, MD, The
University of Texas MD Anderson Cancer Center, Department of
Leukemia, Houston, TX
Session Name: 704, cellular
immunotherapies, Clinical Poster I
Date & Time & Location: December 11,
2021 5:30-7:30PM ET, Georgia World Congress Center, Hall B5
TALGlobin01; an autologous ex
vivo TALEN®-edited CD34+ HSC therapy for the
treatment of Sickle Cell Disease
Sickle cell disease (SCD) is a common inherited
disease that stems from a single mutation in the HBB gene.
TALGlobin01 is an autologous cell-based gene
therapy product designed to repair the mutated b-globin gene (HBB),
and subsequently restore production of Hemoglobin A in HBSS sickle
cell disease.
The data that will be presented are the first demonstration that
TALEN®-based engineering could be used to correct the mutation in
the beta-globin gene of homozygous sickle cell anemia
patient-derived hematopoietic stem and progenitor cells. The data
showed high level of hemoglobin A expression, reversion of sickling
phenotype, the capacity of TALGlobin01 edited cells to engraft in
vivo, and a low level of off-target cleavage. Collectively, the
data demonstrate high efficiency and safety of TALEN® treatment in
HSPCs and positioned it as the best-in-class gene editing
technology for gene therapy product development.
Poster Abstract Session:
Title: Pre-clinical development of a highly efficient
TALEN®-based correction of
β-globin gene in patient-derived hematopoietic stem and progenitor
cells (HSPCs) to treat sickle cell disease
Abstract: #1856 Presenter:
Julien Valton, PhD, Vice President Gene Therapy, Cellectis
Session Name: 801, Gene therapies Poster I
Session Date & Time & Location: Dec 11,
2021, 5:30-7:30PM ET, Georgia World Congress Center, Hall B5
ASH abstracts are now available on www.hematology.org
About Cellectis Cellectis
is a gene editing company, developing first of its kind therapeutic
products. 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 21 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.
As part of its commitment to a cure, Cellectis
remains dedicated to its goal of providing lifesaving UCART product
candidates for multiple cancers including acute myeloid leukemia
(AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple
myeloma (MM). .HEAL is a new platform focusing on
hemopoietic stem cells to treat blood disorders, immunodeficiencies
and lysosomal storage diseases.
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: Margaret Gandolfo, Senior
Manager, Communications, +1 (646) 628 0300 Pascalyne
Wilson, Director, Communications, +33776991433,
media@cellectis.com
Investor Relation
contact: Eric Dutang, Chief Financial
Officer, +1 (646) 630 1748, investor@cellectis.com
Forward-looking Statements
This presentation 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
“believe,” “expect,” “on track,” “plan,” “will,” “could”,
“encouraging”, “designed to”, “intented to”, 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,
include statements about our research and development projects and
priorities, our pre-clinical project development efforts and the
timing of our presentation of data. 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 as well as the
duration and severity of the COVID-19 pandemic and governmental and
regulatory measures implemented in response to the evolving
situation. 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, 2020 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.
- 20211104_ASH 2021 PR_ENGLISH-
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