Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-501/501A in Large B Cell Lymphoma at the International Conference on Malignant Lymphoma (ICML) Lugano
09 Junho 2023 - 7:25PM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer, today announced it will
present data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A
in patients with relapsed/refractory (r/r) large B-cell lymphoma
(LBCL) in an oral presentation at the International Conference on
Malignant Lymphoma (ICML) on June 13–17, 2023 in Lugano,
Switzerland. This presentation will feature additional data on the
33 CAR T naïve patients treated with the Alloy™ manufacturing
process across different CAR T dosing and lymphodepletion regimens.
Earlier in June, data from the 12 patients who received a single
ALLO-501/A cell infusion following the lymphodepletion regimen
being utilized in the ongoing potentially pivotal Phase 2 trials
was presented at American Society of Clinical Oncology (ASCO)
Annual Meeting.
The ALPHA/ALPHA2 Phase 1 trials were designed to assess the
safety, tolerability, and preliminary efficacy at increasing dose
levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product
candidates that target CD19. In addition to exploring multiple cell
doses and dosing schedules (consolidation), these studies evaluated
various doses of ALLO-647, Allogene’s proprietary lymphodepleting
antibody designed to prevent premature rejection of AlloCAR T
cells. Allogene is currently enrolling the potentially pivotal
Phase 2 ALPHA2 trial of ALLO-501A in LBCL and expects to complete
enrollment in 1H2024. The Company expects to open trial sites in
Europe, Canada and Australia during 2023.
Allogene Presentation at the 2023 ICML Lugano:
Durable responses with anti-CD19 allogeneic CAR T
ALLO-501/501A in phase 1 trials of relapsed/refractory large B-cell
lymphoma (r/r LBCL)
Presenter: Dr. Frederick Locke, M.D.,
Chair, Department of Blood and Marrow Transplant and
Cellular Immunotherapy; program co-leader,
Immuno-Oncology, Moffitt Cancer Center Tampa,
FloridaAbstract: #48Oral Presentation Date and Time: June 15,
2023, 15:30 CEST / 9:30am EST / 6:30am PST
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 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 Twitter and
LinkedIn.
Cautionary Note on Forward-Looking Statements for
AllogeneThis 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 “could,” “designed,”
“expects,” “potential,” “preliminary,” “will” 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:
the potential of allogeneic CD19 CAR T product candidates to
generate durable complete responses similar to approved autologous
therapies; the potential of the Phase 2 ALPHA2 trial to be a
pivotal trial; Allogene’s expectation to complete enrollment of the
Phase 2 ALPHA2 trial in the first half of 2024; Allogene’s
expectation to open trial sites for the Phase 2 ALPHA2 trial in
Europe, Canada and Australia during 2023; the design of Allogene’s
trials and ALLO-647; data results that may be implied from prior
results; and the potential benefits of AlloCAR T products. 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; Phase 1
data from our clinical trials is limited and may change as more
patient data become available or may not be validated in any future
or advanced clinical trial; our ability to maintain intellectual
property rights necessary for the continued development of our
product candidates, including pursuant to our license agreements;
our product candidates may cause undesirable side effects or have
other properties that could halt their clinical development,
prevent their regulatory approval or limit their commercial
potential; the extent to which COVID-19 adversely impacts our
business, including our clinical trials; the extent to which
the FDA disagrees with our clinical or regulatory plans,
which could cause future delays to our clinical trials or require
additional clinical trials; we may encounter difficulties enrolling
patients in our clinical trials; we may not be able to demonstrate
the safety and efficacy of our product candidates in our clinical
trials, which could prevent or delay regulatory approval and
commercialization; challenges with manufacturing or optimizing
manufacturing of our product candidates; and our ability to obtain
additional financing to develop our products and implement our
operating plans. These and other risks are discussed in greater
detail in Allogene’s filings with the SEC, including without
limitation under the “Risk Factors” heading of its Form 10-Q for
the quarter ended March 31, 2023. 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 the Cellectis
TALEN® 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
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
Additional Allogene Media Contact:Madeleine
GoldsteinManager, Corporate & Pipeline
CommunicationsMadeleine.Goldstein@allogene.com
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