Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer, today announced that it will
have two poster presentations focused on the importance of
lymphodepletion in allogeneic cell therapy at the 65th Annual
Meeting of the American Society of Hematology (ASH) taking place
December 9-12, 2023 in San Diego, CA.
“All CAR T cells require lymphodepletion to support the
expansion and persistence needed to eradicate malignant cells.
Because of the risk of allorejection by the patient’s immune
system, creating the necessary window of persistence for an
off-the-shelf, allogeneic CAR T product may require an enhanced
approach to lymphodepletion. These results reinforce our belief
that Allogene’s strategy of adding ALLO-647, an anti-CD52
monoclonal antibody candidate, to the standard
fludarabine/cyclophosphamide (flu/cy) lymphodepletion regimen in
our ALPHA/ALPHA2 studies can safely achieve this,” said Zachary
Roberts, M.D., Ph.D., Executive Vice President of Research &
Development and Chief Medical Officer of Allogene. “Our unique and
proprietary lymphodepletion regimen that includes ALLO-647 has been
shown to potentially induce deep and durable remissions in relapsed
and treatment-refractory cancers.”
The first poster is a comprehensive safety review of all 85
patients treated in the Phase 1 ALPHA/ALPHA2 studies in
relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and
follicular lymphoma (FL) to characterize the overall safety profile
when ALLO-647 is added to standard lymphodepletion.
In June 2023 at the International Conference on Malignant
Lymphoma (ICML) in Lugano, Switzerland, the Company
presented updated data from the Phase 1 ALPHA/ALPHA2 trials of
investigational ALLO-501/501A in 33 CAR T naïve patients with r/r
LBCL treated with the Alloy™ manufacturing process material across
different CAR T dosing and lymphodepletion regimens. Data from the
12 patients, a subset of these 33 CAR T naïve patients, who
received the regimen being utilized in ongoing Phase 2 trials was
presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting. These data demonstrated that administration of the
anti-CD19 allogeneic CAR T product candidate following a 3-day
lymphodepletion regimen that includes fludarabine 30 mg/m2 and
cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of
ALLO-647 in divided doses can potentially yield durable responses
and an acceptable safety profile in line with approved autologous
CAR T therapies.
Title: ALLO-647 for Lymphodepletion in the
Allogeneic CAR T Setting: Safety Experience with ALLO-501/501A in
Patients (Pts) with Relapsed/Refractory (r/r) Large B-Cell and
Follicular Lymphomas Session: 704. Cellular
Immunotherapies: Early Phase and Investigational Therapies: Poster
I Abstract: 2095Presenter:
Dr. Frederick Locke, M.D., Chair, Department of Blood and
Marrow Transplant and Cellular Immunotherapy; program
co-leader, Immuno-Oncology, Moffitt Cancer CenterTampa,
FloridaSession Date & Time: Saturday, December
9, 2023, 5:30 PM - 7:30 PM PTLocation:
San Diego Convention Center, Halls G-H
The second poster showcases translational results from ALPHA2
generated through a collaboration with researchers from The
University of Texas MD Anderson Cancer Center. This study compared
expansion kinetics among 11 allogeneic CAR T recipients treated
with investigational ALLO-501A in the ALPHA2 trial. The study
revealed the impact of recipient alloreactive CD8+ T cells in
allogeneic CAR T rejection. Results of this study could help define
strategies to improve allogeneic CAR T expansion, persistence, and
efficacy.
Title: Cellular Mechanisms Affecting Allogeneic
CAR T Cell Expansion and Rejection in Large B-cell
LymphomaSession: 703. Cellular Immunotherapies:
Basic and Translational: Poster IIIAbstract:
#4832Presenter: Andrew P. Jallouk, M.D.,
Ph.D,Vanderbilt / MD AndersonSession Date &
Time: Monday, December 11, 2023 6:00pm – 8:00pm
PTLocation: San Diego Convention Center, Halls
G-H
About ALLO-501 and ALLO-501AALLO-501 and
ALLO-501A are anti-CD19 AlloCAR T investigational products for the
treatment of large B cell lymphoma. ALLO-501A, a next-generation
anti-CD19 AlloCAR T, eliminates the rituximab recognition domains
in ALLO-501, which could allow for use in a broader patient
population, including NHL patients with recent rituximab exposure.
This product candidate is currently being studied in an ongoing
potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and
Drug Administration granted Regenerative Medicine Advanced Therapy
(RMAT) designation to ALLO-501A in r/r LBCL.
About Allogene TherapeuticsAllogene
Therapeutics, with headquarters in South San Francisco, is a
clinical-stage biotechnology company pioneering the development of
allogeneic chimeric antigen receptor T cell (AlloCAR T™) products
for cancer. Led by a management team with significant experience in
cell therapy, Allogene is developing a pipeline of “off-the-shelf”
CAR T product candidates with the goal of delivering readily
available cell therapy on-demand, more reliably, and at greater
scale to more patients. For more information, please
visit www.allogene.com, and follow @AllogeneTx on X (formerly
Twitter) and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The press release may, in some cases, use terms
such as "predicts," "believes," "potential," "proposed,"
"continue," "estimates," "anticipates," "expects," "plans,"
"intends," "may," “can,” "could," "might," "will," "should,”
“designed to” or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: Allogene’s ability to deliver
readily available off-the shelf cell therapy on-demand, more
reliably, and at greater scale to more patients; and the modes of
action, the therapeutic effects and safety profile of Allogene’s
product candidates including their ability to treat cancers at
various stages or to treat broad populations. Various factors may
cause material differences between Allogene’s expectations and
actual results, including risks and uncertainties related to: our
product candidates are based on novel technologies, which makes it
difficult to predict the time and cost of product candidate
development and obtaining regulatory approval; the FDA may disagree
with our regulatory plan and we may fail to obtain regulatory
approval of our CAR T cell product candidates; and our clinical
trials may fail to demonstrate the safety and efficacy of any of
our product candidates, which would prevent or delay regulatory
approval and commercialization. These and other risks are discussed
in greater detail in Allogene’s filings with the SEC,
including without limitation under the “Risk Factor” Heading in its
Form 10-Q filed for the quarter ended September 30, 2023,
being filed with the SEC today. Any forward-looking statements that
are made in this press release speak only as of the date of this
press release. Allogene assumes no obligation to update the
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Caution should be exercised regarding statements comparing
autologous CAR T data. There are differences in the clinical trial
design, patient populations, published data, follow-up times and
the product candidates themselves, and the results from the
clinical trials of autologous products may have no interpretative
value on Allogene’s existing or future results.
AlloCAR T™ and Alloy™ are trademarks of Allogene
Therapeutics, Inc.
Allogene’s AlloCAR T™ programs utilize Cellectis technologies.
ALLO-501 and ALLO-501A are anti-CD19 products being jointly
developed under a collaboration agreement between Servier and
Allogene based on an exclusive license granted by Cellectis to
Servier. Servier grants to Allogene exclusive rights to ALLO-501
and ALLO-501A in the U.S.
Allogene Media/Investor Contact:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
Additional Allogene Media Contacts:Leslie
BryantLeslie.Bryant@allogene.com
Madeleine GoldsteinMadeleine.Goldstein@allogene.com
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