Cellectis Announces Oral Presentation on AMELI-01 and Poster
Presentation on Multiplex Engineering for Superior Generation of
CAR T-cells at the American Society of Gene and Cell Therapy
(ASGCT) Annual Meeting
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, today announced that it will present clinical data on
its Phase 1 AMELI-01 clinical trial (evaluating UCART123) that were
presented in an oral presentation at the 64th American Society of
Hematology (ASH) annual meeting, as well as preclinical data on
multiplex engineering for superior generation of CAR T-cells, at
the American Society of Gene and Cell Therapy (ASGCT) Annual
Meeting taking place May 16-20, 2023 in Los Angeles, CA.
Oral presentation:
AMELI-01, a study evaluating UCART123,
an allogeneic CAR T-cell product candidate, in relapsed/refractory
acute myeloid leukemia (r/r AML)
The presentation includes preliminary clinical
data from the Phase 1, open-label, dose-escalation trial, AMELI-01,
in patients with r/r AML administered UCART123 following
lymphodepletion (LD) with either fludarabine and cyclophosphamide
(FC) or FC with alemtuzumab (FCA).
The data show that adding alemtuzumab to the FC
regimen was associated with improved LD and significantly higher
UCART123 cell expansion, which correlated with improved
activity.
UCART123 is a novel and genetically modified
allogeneic T-cell product manufactured from healthy donor cells.
Donor-derived T-cells are transduced using a lentiviral vector to
express the anti-CD123 chimeric antigen receptor (CAR) and are
further modified using Cellectis’ TALEN® technology to disrupt the
T-cell receptor alpha constant (TRAC) and CD52 genes to minimize
risk of graft-vs-host disease (GvHD) and allow use of
anti-CD52–directed therapy as a component of the LD regimen,
respectively.
Title: AMELI-01: A
Phase I Trial of UCART123v1.2, an Anti-CD123 Allogeneic CAR-T Cell
Product, in Adult Patients with Relapsed or Refractory (R/R) CD123+
Acute Myeloid Leukemia (AML)Session
Date/Time: 5/17/2023 - 3:45 PM – 5:30PM PDTSession
Title: CAR Engineering and Production Advances for
Targeting Hematologic and Solid Tumor MalignanciesSession
Room: 502 ABFinal Abstract Number: 94
Poster presentation: Expanding the scope
of multiplex engineering for superior generation of efficient CAR
T-cells
CAR T-cell therapies have revolutionized the way
we can treat hematological malignancies. However, additional
physiological and biological barriers imposed by the hostile tumor
microenvironment has limited the ability to target solid tumors. In
recent years, advances in genomic-based cellular engineering are
bringing us a step closer to conquer solid tumors. This glimpse of
success also demonstrated that we need to be able to creatively
customize and equip CAR T-cells to target these tumors.
In this presentation, Cellectis shows how we can
use its state-of-the-art TALEN® technology to precisely edit up to
four loci simultaneously while delivering several additional
payloads to increase the efficacy and persistence of CAR
T-cells.
Cellectis takes it a step further and uses a
curated combination of genome engineering technologies including
TALE base editors to leverage the efficiency of multiplexed gene
editing while safeguarding genomic integrity. By carefully choosing
a range of gene and cell engineering approaches, Cellectis can
develop CAR T-cells focused on unmet medical needs with a high
level of efficiency for gene editing and targeted-integration.
Title: Expanding the Scope of Multiplex
Engineering for Superior Generation of Efficient CAR
T-cellsSession Date/Time: 5/17/2023
12:00 PM PDTSession Title: Wednesday Poster
SessionPoster Board Number: 604Final
Abstract Number: 604
Details from the presentations will be available
following the event on the Cellectis website at:
https://www.cellectis.com/en/investors/scientific-presentations/
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
23 years of experience and 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).
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 advancements, timing and
progress of clinical trials, the adequacy and continuity of supply
of clinical supply and alemtuzumab, the ability of an anti-CD52 as
alemtuzumab to improve any efficacy and the potential benefit of
UCART product candidates. 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, 2022 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.
For further information on Cellectis, please
contact:
Media
contact:
Pascalyne Wilson, Director, Communications, +33
(0)7 76 99 14 33, media@cellectis.com
Investor Relations
contacts:
Arthur Stril, Chief Business Officer, +1 (347) 809 5980,
investors@cellectis.com
Ashley R. Robinson, LifeSci Advisors, +1 617 430
7577
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