Allogene Therapeutics Announces Encore Presentation of Phase 1 Data from the ALLO-501/501A Trials in Large B Cell Lymphoma at the European Hematology Association (EHA) Hybrid Congress
11 Maio 2023 - 12:50PM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer, today announced an encore
presentation of data from the Phase 1 ALPHA/ALPHA2 trials of
ALLO-501/501A at the European Hematology Association (EHA) Hybrid
Congress on June 8–11, 2023 in Frankfurt, Germany.
The ALPHA/ALPHA2 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 cell doses, these
studies evaluated escalating doses of ALLO-647, Allogene’s
proprietary investigational lymphodepleting antibody designed to
prevent premature rejection of AlloCAR T cells, in combination with
fludarabine and cyclophosphamide.
Allogene is conducting ALPHA2 and EXPAND, two potentially
pivotal Phase 2 trials of ALLO-501A in large B cell lymphoma (LBCL)
in sites across the U.S. and is expected to extend its clinical
research footprint to Europe, Canada and Australia in 2023.
Allogene Presentation at the 2023 EHA Hybrid Congress:
Title: Durable Responses Achieved with Anti-CD19
Allogeneic CAR T ALLO-501/501A in Phase 1 Trials of Autologous CAR
T Naïve Patients with Relapsed/Refractory Large B Cell Lymphoma
(R/R LBCL)
Presenter: Dr. Javier Munoz, M.D., M.B.A, Director of the
Lymphoma Program at Mayo Clinic in Phoenix,
ArizonaAbstract: P1125Poster Session Display Date and Time:
Friday, June 9, 2023, 18:00 - 19:00 CEST/ 9:00AM - 10:00AM PT/
12:00PM - 1:00PM ET
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 the Phase 2 ALPHA2 trial to be a pivotal trial;
expectations with respect to expansion of Allogene’s clinical
research footprint to Europe, Canada, and Australia; 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.
AlloCAR T™ is a trademark 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
Allogene Therapeutics (NASDAQ:ALLO)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Allogene Therapeutics (NASDAQ:ALLO)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024