Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) therapies for cancer, in collaboration with its
development partner Servier, an independent international
pharmaceutical company, today announced that longer-term follow-up
data from Allogene’s dose escalation Phase 1 ALPHA study of
ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be
jointly presented with initial data from the ALPHA2 trial of
ALLO-501A at the 2021 American Society of Clinical Oncology (ASCO)
Annual Meeting being held virtually June 4 - 9, 2021. A separate
poster presentation will detail safety and biomarker findings from
ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion
with fludarabine (Flu)/cyclophosphamide (Cy) in patients with
relapsed/refractory non-Hodgkin lymphoma and multiple myeloma.
These Phase 1 trials are designed to assess the safety and
tolerability at increasing dose levels of ALLO-501, ALLO-501A and
ALLO-647 in the most common NHL subtypes of relapsed/refractory
diffuse large B-cell lymphoma or follicular lymphoma. ALLO-501A, a
next-generation anti-CD19 AlloCAR T™ intended for Phase 2
development in diffuse large B cell lymphoma (DLBCL), 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.
“We are excited to present the first clinical data on ALLO-501A,
our anti-CD19 AlloCAR T candidate intended for registrational
trials in DLBCL, along with longer-term follow up from ALPHA, our
first Phase 1 study of ALLO-501,” said Rafael Amado, MD, Executive
Vice President of Research & Development and Chief Medical
Officer of Allogene. “Over the past year, we have moved quickly and
diligently to advance multiple AlloCAR T programs into the clinic
using innovative technologies and across a variety of malignancies.
We’re looking forward to discussing our progress in these two
foundational studies during our virtual CD19 Forum.”
Allogene will host a virtual CD19 Forum for investors and other
interested parties on May 19, 2021 at 2:30 p.m. Pacific Time/5:30
p.m. Eastern Time. The Forum will include data being presented at
the virtual 2021 ASCO Annual Meeting along with discussion from
clinical investigators and Allogene’s vision for the future of its
AlloCAR T platform.
Allogene presentations at the virtual 2021 ASCO Annual
Meeting:
First-in-human data of ALLO-501A, an allogeneic chimeric
antigen receptor (CAR) T-cell therapy and ALLO-647 in
relapsed/refractory large B-cell lymphoma (R/R LBCL): ALPHA2
study.Presenter: Frederick Locke, MD, H. Lee Moffitt
Cancer Center and Research Institute, Vice Chair of the Department
of Blood and Marrow Transplant and Cellular Immunotherapy Poster
Session Title: Developmental Therapeutics—ImmunotherapyAbstract
#2529Session Release Date: June 4, 2021
Safety and PK/PD of ALLO-647, an anti-CD52 antibody,
with fludarabine (Flu)/cyclophosphamide (Cy) for lymphodepletion in
the setting of allogeneic CAR-T cell therapy.Presenter:
Michael Tees, MD, Colorado Blood Cancer Institute/Sarah Cannon,
Associate Member Physician Poster Session Title: Developmental
Therapeutics—ImmunotherapyAbstract # 2527Session Release Date: June
4, 2021
Virtual CD19 ForumAdditional information on the
Virtual CD19 Forum will be made available in a separate press
release and on the Company's website at www.allogene.com under the
Investors tab in the News and Events section. Materials presented
will be available on the Allogene website prior to the start of the
event.
About ALLO-501 (Allogene Sponsored)ALLO-501 is
an anti-CD19 allogeneic CAR T (AlloCAR T™) therapy being jointly
developed under a collaboration agreement between Servier and
Allogene based on an exclusive license granted by Cellectis to
Servier and utilizing Cellectis technologies. Servier grants to
Allogene exclusive rights to ALLO-501 in the U.S. while Servier
retains exclusive rights for all other countries.
About ALLO-501A (Allogene Sponsored)ALLO-501A,
a next-generation anti-CD19 AlloCAR T™ intended for Phase 2
development, 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.
Like ALLO-501, ALLO-501A is being jointly developed under a
collaboration agreement between Servier and Allogene based on an
exclusive license granted by Cellectis to Servier and utilizing
Cellectis technologies. ALLO-501A uses the Cellectis TALEN
technology. Servier grants to Allogene exclusive rights to
ALLO-501A in the U.S. while Servier retains exclusive rights for
all other countries.
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™) therapies for cancer. Led by a world-class management
team with significant experience in cell therapy, Allogene is
developing a pipeline of “off-the-shelf” CAR T cell
therapy 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.
About ServierServier is a global pharmaceutical
group governed by a Foundation. With a strong international
presence in 150 countries and a total revenue of 4.7 billion euros
in 2020, Servier employs 22,500 people worldwide. Servier is an
independent group that invests over 20% of its brand-name revenue
in Research and Development every year. To accelerate therapeutic
innovation for the benefit of patients, the Group is committed to
open and collaborative innovation with academic partners,
pharmaceutical groups, and biotech companies. It also integrates
the patient's voice at the heart of its activities, from research
to support beyond the pill.
A leader in cardiology, the ambition of the
Servier Group is to become a recognized and innovative player in
oncology. Its growth is based on a sustained commitment to
cardiovascular and metabolic diseases, oncology, and
immuno-inflammatory and neurodegenerative diseases. To promote
access to healthcare for all, the Servier Group also offers a range
of quality generic drugs covering most pathologies. More
information: www.servier.com
Servier Group press contacts:Sonia Marques:
presse@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28
76 13Jean-Clément Vergeau: presse@servier.com – Tel. +33 (0)1 55 46
16 / +33 6 79 56 75 96
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 "predicts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should" 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 timing and ability to progress
the ALPHA and ALPHA2 trials, including progressing to the Phase 2
portion of the ALPHA2 trial, and present any data from the trials,
clinical outcomes, which may materially change as patient
enrollment continues and more patient data become available, and
the potential benefits of AlloCAR T™ therapy. Various factors may
cause differences between Allogene’s expectations and actual
results as discussed in greater detail in Allogene’s filings with
the Securities and Exchange Commission (SEC), including
without limitation in its Form 10-K for the year
ended December 31, 2020. 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 Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
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