Cellectis to Present Preliminary Results of NATHALI_01 and Updated Results of the BALLI_01 Phases I Trials at the American Society of Hematology (ASH) 65th Annual Meeting
November 02 2023 - 4:30PM
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 today that preliminary results of the Phase I
NATHALI-01 clinical trial evaluating UCART20x22 in patients with
relapsed or refractory non-Hodgkin lymphoma (r/r NHL) and updated
results of the Phase I BALLI-01 clinical trial evaluating UCART22
in patients with relapsed or refractory CD22+ B-cell acute
lymphoblastic leukemia, (r/r B-ALL) will be presented at the
American Society of Hematology 65th Annual Meeting (ASH 2023), that
will take place on December 9-12, 2023 in San Diego (CA) and
online.
These data will be presented in two poster
sessions:
Poster Presentation (P2110)
Title: Preliminary Results of
Nathali-01: A First-in-Human Phase I/IIa Study of UCART20x22, a
Dual Allogeneic CAR-T Cell Product Targeting CD20 and CD22, in
Relapsed or Refractory (R/R) Non-Hodgkin Lymphoma (NHL)
Session Name: 704. Cellular
Immunotherapies: Early Phase and Investigational Therapies: Poster
I
Presenter: Dr. Jeremy Abramson
(Massachusetts General Hospital Cancer Center)
Date/Time: Saturday, December
9, 2023 at 5:30 - 7:30 PM PT at San Diego Convention Center,
Halls G-H
The poster presentation highlights the following
data:
- as of July 1, 2023,
3 patients were enrolled and treated at dose level 1 (50 million
cells) with product manufactured in-house by Cellectis. Cytokine
release syndrome (CRS) Grade 1 or 2 occurred in all patients, and
all CRS resolved with treatment.
- No immune effector
cell associated neurotoxicity (ICANS) or graft versus host disease
(GvHD) was observed. There were no UCART20x22 dose limiting
toxicities (DLTs), and there was 1 DLT in connection with CLLS52
(alemtuzumab).
- All patients
responded at Day 28, with 1 partial metabolic response and 2
complete metabolic responses in patients who had failed prior
autologous CD19 CAR T-cell therapies.
- UCART20x22
expansion correlated with increases in serum cytokine and
inflammatory marker levels as well as with CRS.
- These initial data
support the continued clinical trial evaluating UCART20x22 in R/R
NHL.
Poster Presentation (P4847)
Title: Updated Results of the
Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22
Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics,
in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute
Lymphoblastic Leukemia (B-ALL)
Session Name: 704. Cellular
Immunotherapies: Early Phase and Investigational Therapies: Poster
III
Presenter: Dr. Nitin Jain
(University of Texas MD Anderson Cancer Center)
Date/Time: Monday, December 11,
2023 at 6:00 - 8:00 PM PT at San Diego Convention Center,
Halls G-H
The poster presentation highlights the following
data:
- In vitro
comparability studies suggested that UCART22 Process 2 (P2)
(manufactured in-house by Cellectis) is more potent than UCART22
Process 1 (P1) (manufactured by an external CDMO), and as of July
1, 2023, 3 patients were enrolled into the first UCART22 P2 cohort
at dose level 2 (1 million cells/kg).
- UCART22 P2 was
administered after fludarabine, cyclophosphamide, and alemtuzumab
(FCA) lymphodepletion regimen and was well tolerated. No DLTs or
ICANS was observed, and the CRS observed was Grade 1 or
2.
- There was a higher
preliminary response rate (67%) at dose level 2 (1 million
cells/kg) with UCART22 P2 (manufactured in-house by Cellectis)
compared to 50% at dose level 3 (5 million cells/kg) with UCART22
P1 (manufactured by an external CDMO).
- UCART22 expansion
was observed in the responding patients and correlated with
increases in serum cytokines and inflammatory markers.
- The study continues
to enroll patients at dose level 2i (2.5 million cells/kg) with
UCART22 P2.
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,” “expect,” “plan,” “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,
include statements about the preliminary results for the NATHALI-01
and BALLI-01 clinical trials and the objectives of such trials,
which remain ongoing; the ability to progress our clinical trials
and to present any additional data from these trials; clinical
outcomes from our clinical trials, which may materially change as
more patient data becomes available, potential benefits of our
UCART product candidates; and our manufacturing capabilities. 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:
Patricia Sosa Navarro, Chief of Staff to the
CEO, +33 (0)7 76 77 46 93, 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
- ASH_2023_curtain raiser_ENGLISH
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