Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer and autoimmune disease, today
announced that Rocky Mountain Cancer Centers (RMCC), part of the US
Oncology Network and Sarah Cannon Research Institute (SCRI); Astera
Cancer Care (ACC), a multi-specialty community oncology practice
and part of the OneOncology network; and Norton Cancer Institute,
are open for enrollment in the pivotal Phase 2 ALPHA3 trial.
The ALPHA3 trial is evaluating the use of cemacabtagene
ansegedleucel (cema-cel) as part of the first line (1L)
consolidation treatment regimen for newly diagnosed and treated
large B-cell lymphoma (LBCL) patients who remain positive for
minimal residual disease (MRD). Detection of MRD will be done using
the Foresight CLARITY™ Investigational Use Only (IUO) MRD test,
powered by PhasED-Seq™. When given as a “7th cycle” of frontline
treatment to eligible patients with MRD, consolidation treatment
with cema-cel has the potential to meaningfully improve 1L cure
rates for patients with LBCL who are likely to relapse.
“We believe community physicians have been waiting for a trial
like ALPHA3 that offers cutting-edge CAR T without the inherent
complexities associated with autologous therapies,” said David
Chang, M.D., Ph.D., President, Chief Executive Officer and
Co-Founder of Allogene. “The differentiated attributes of cema-cel
eliminate many of the complex logistics that have hindered CAR T
adoption in the community setting. The fact that community-based
practices are the first sites to open for enrollment in the ALPHA3
trial is a significant symbolic step forward in expanding patient
access to this powerful modality and will serve as a catalyst for
our cema-cel development program.”
RMCC is the largest multidisciplinary practice in Colorado with
19 locations across the state dedicated solely to providing care
for patients with cancer and diseases of the blood. RMCC is a part
of SCRI, a combination of two nationally recognized oncology
research institutes – US Oncology and SCRI. This combination
creates a leading oncology research organization participating in
community-based clinical trials. Patients undergoing treatment for
newly diagnosed LBCL throughout the RMCC network will be considered
for enrollment in ALPHA3.
“Current 1L chemoimmunotherapy is effective in most patients,
but the reality is that 30% will relapse,” said John M. Burke,
M.D., a Blood Cancer Specialist at RMCC. “The ALPHA3 trial will be
answering two key questions. First, can measuring circulating tumor
DNA in the blood be used to select lymphoma patients destined to
relapse for early intervention? And second, does treating these
high-risk lymphoma patients with cema-cel increase cure rates
compared with conventional surveillance? These are critically
important questions that have the potential to change the lymphoma
treatment paradigm.”
ACC is an independent and physician-owned multi-specialty
community oncology practice serving more than 22,000 new patients
annually in Central New Jersey. The practice is part of the
OneOncology platform which is a partnership of over 20 independent
community oncology practices nationally. Astera’s specialists
practice at 13 distinct locations in Middlesex, Somerset, Bergen,
Hudson, Hunterdon, Mercer and Monmouth counties in New Jersey and
Langhorne, Pennsylvania and have a robust clinical trial platform
for cancer therapy with one of the only community-based clinical
trial programs in CAR T cell therapies in the nation. Patients
undergoing treatment for newly diagnosed LBCL throughout the ACC
network will be considered for enrollment in ALPHA3.
According to Edward J. Licitra, M.D., PhD, oncologist and
Chairman and Chief Executive Officer at ACC, relapsed LBCL is much
more difficult to treat, and physicians often consider enrollment
in clinical trials to allow access to promising therapies. “I have
watched with interest the acceleration of CAR T research in LBCL,
but because most patients live more than two hours from the nearest
treatment center, it’s not feasible for them to participate. Having
access to an “off-the-shelf” CAR T product with a manageable safety
profile changes that equation dramatically for me, and my patients.
We are excited to help define a new treatment standard in LBCL. An
approved “off-the-shelf” CAR T product would allow for greater
access to cutting edge technologies for patients in their local
communities and this could improve outcomes for many more cancer
patients.”
With more than 21 locations serving Louisville, Kentucky and
Southern Indiana, Norton Cancer Institute (NCI) treats more than
4,000 newly diagnosed cancer patients each year. NCI’s network of
multidisciplinary clinics offers patients the latest treatments and
access to more than 100 clinical trials.
“Kentucky has one of the highest cancer death rates in the
United States1 and a big contributor to this is lack of patient
access to cutting-edge treatments,” said Don A. Stevens, M.D., a
hematologist-oncologist at Norton Cancer Institute. “Offering
investigational cema-cel to our first line patients has the
potential to improve cure rates for the 30% we know will relapse
after chemoimmunotherapy. This could change how we treat these
patients in the future.”
About Cemacabtagene Ansegedleucel
(cema-cel)Cemacabtagene ansegedleucel, or cema-cel, is a
next generation anti-CD19 AlloCAR T™ investigational product for
the treatment of large B cell lymphoma (LBCL). In June 2022,
the U.S. Food and Drug Administration granted
Regenerative Medicine Advanced Therapy (RMAT) designation to
cema-cel in third line (3L) r/r LBCL. The ALPHA3 pivotal Phase 2
trial in first line (1L) consolidation for the treatment of LBCL
launched in June 2024. Allogene has oncology rights to cema-cel in
the US, EU and UK with options for rights in China and Japan.
About the ALPHA3 TrialOver 60,000 patients are
expected to be treated for LBCL annually in the US, the EU and the
UK. While first line (1L) R-CHOP or other chemoimmunotherapy is
effective for most patients, approximately 30% will relapse and
require subsequent treatment. The current standard of care (SOC)
after 1L treatment has been simply to “watch and wait” to see if
the disease relapses. The pivotal Phase 2 ALPHA3 study takes
advantage of cema-cel as a one-time, off-the-shelf treatment that
can be administered immediately upon discovery of MRD following six
cycles of R-CHOP or other chemoimmunotherapy, positioning it to
become the standard “7th cycle” of frontline treatment
available to all eligible patients with MRD.
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 and autoimmune disease. Led by a
management team with significant experience in cell therapy,
Allogene is developing a pipeline of “off-the-shelf” CAR T cell
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 Allogene
Therapeutics on X (formerly Twitter) and LinkedIn.
Cautionary Note on Forward-Looking Statements for
Allogene This press release contains forward-looking
statements for purposes of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. This press
release may, in some cases, use terms such as “believes,”
“potential,” “likely to,” “expect,” “can,” “become,” “may,”
“could,” or “will,” including alternative forms thereof, 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: ALPHA3 being a pivotal trial and the extent to
which it will support regulatory approval of cema-cel; the
potential for the ALPHA3 trial or the ability for Foresight’s
minimal residual disease test to identify patients with LBCL who
are likely to relapse following standard 1L treatment; the
potential for cema-cel to become the standard “7th cycle” of
frontline treatment; the timing for completion of ALPHA3 enrollment
or cema-cel BLA submission; delivery of cema-cel with fewer
complexities associated with autologous therapies; expanding
patient access to cutting edge technologies such as CAR T; the
extent to which patients throughout various networks will be
considered for enrollment in ALPHA3; the incidence of LBCL
including the extent to which patients will relapse and require
subsequent treatment; the potential for our product candidates to
be approved; the potential benefits of the ALPHA3 trial and of
AlloCAR T™ products, including the potential for ALPHA3 to change
the lymphoma treatment paradigm, define a new LBCL treatment
standard, or improve cure rates or patient outcomes; cema-cel’s
safety profile; the ability of ALPHA3 to answer various questions;
our ability to broaden patient access to CAR T therapy and deliver
cell therapy on-demand, more reliably, and at greater scale to more
patients. 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 ability of ALPHA3 to offer a potentially curative modality to
patients who are at risk of relapse; the ability and extent that
cema-cel will be administered as a one-time infusion; the extent to
which the Food and Drug Administration disagrees with our clinical
or regulatory plans or the import of our clinical results, 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; and challenges with manufacturing or optimizing
manufacturing of our product candidates. These and other risks are
discussed in greater detail in Allogene’s filings with the
Securities and Exchange Commission (SEC), including without
limitation under the “Risk Factors” heading in its Quarterly Report
on Form 10-Q for the quarter ended March 31, 2024. 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.
The Foresight CLARITY™ MRD test, powered by PhasED-Seq™ is for
investigational use only.
AlloCAR T™ is a trademark of Allogene Therapeutics,
Inc.CLARITY™ and PhasED-Seq™ are trademarks of Foresight
Diagnostics.
Allogene’s investigational AlloCAR T™ oncology products utilize
Cellectis technologies. These products are developed based on an
exclusive license granted by Cellectis to Servier. Servier, which
has an exclusive license to the anti-CD19 AlloCAR T™
investigational products from Cellectis, has granted Allogene
exclusive rights to these products in the U.S., all EU Member
States and the United Kingdom.
Media/Investor Contacts:Christine CassianoEVP,
Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
Leslie BryantSenior Communications
ConsultantLeslie.Bryant@Allogene.com
1 US News & World Report. You’re More Likely to Die of
Cancer if You Live in This State (usnews.com). Accessed
25June2024.
Allogene Therapeutics (NASDAQ:ALLO)
Gráfica de Acción Histórica
De Sep 2024 a Oct 2024
Allogene Therapeutics (NASDAQ:ALLO)
Gráfica de Acción Histórica
De Oct 2023 a Oct 2024