Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products, and Foresight Diagnostics (Foresight), a
leader in ultra-sensitive liquid biopsy-based minimal residual
disease (MRD) detection, today announced the initiation of the
pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene
ansegedleucel (cema-cel) as part of the first line (1L) treatment
regimen for newly diagnosed LBCL patients who are likely to relapse
after standard 1L treatment and need further therapy.
“The transformative impact that the ALPHA3 trial could have on
the treatment of first line LBCL is hard to overstate,” said David
Chang, M.D., Ph.D., President, Chief Executive Officer and
Co-Founder of Allogene. “Our investigational allogeneic CAR T
product is designed to eliminate the complex logistics that have
hindered autologous CAR T adoption to date and open the door for
access by doctors in the community setting. ALPHA3 will proactively
offer this potentially curative modality only to those patients who
are likely to relapse.”
The ALPHA3 trial will screen patients who are likely to relapse
after 1L treatment for enrollment in the trial by using the
Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered
by PhasED-Seq™, which recently received Investigational Device
Exemption (IDE) approval from the U.S. Food and Drug Administration
(FDA). Leveraging CLARITY’s ultra-sensitive MRD technology,
cema-cel will be administered as a one-time infusion immediately
upon detection of MRD at the completion of six cycles of R-CHOP or
other standard 1L chemoimmunotherapy regimen. 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 in LBCL.
“Following the FDA Advisory Committee’s recent recommendation to
include MRD as an endpoint to accelerate clinical trials in
multiple myeloma, the ALPHA3 trial is yet another step forward
towards broader implementation of MRD detection in drug development
and clinical decision making,” said Dr. Sandra Close, Chief
Operating and Compliance Officer at Foresight Diagnostics. “We
believe the Foresight CLARITY MRD platform has the performance to
enable actionable treatment decisions at end of therapy when
residual disease levels are challenging to detect using
conventional methods.”
The ALPHA3 trial will be conducted in a wide array of cancer
treatment centers, including community cancer centers where most
earlier line patients seek care. This randomized study will enroll
approximately 240 patients and is designed to demonstrate a
meaningful improvement in event free survival (EFS) in patients
treated with cema-cel relative to patients who receive the current
standard of care (observation). Efficacy analyses are expected to
occur in 2026 and will include an interim EFS analysis monitored by
the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and
the data readout of the primary EFS analysis in 2H 2026 with a
potential biologics license application (BLA) submission targeted
for 2027.
About Foresight Diagnostics Foresight
Diagnostics is a privately-held cancer diagnostics company and
CLIA-registered laboratory. Its liquid biopsy platform, Foresight
CLARITY™, is a novel assay that measures minimal residual disease
(MRD) with reported detection limits in parts per million1. The
improved sensitivity of Foresight CLARITY has the potential to
provide actionable information to physicians and biopharmaceutical
companies to enable more personalized treatment approaches for
patients with solid tumor and hematologic malignancies. For more
information, please visit foresight-dx.com and follow us
on Twitter and LinkedIn. Foresight CLARITY™ IUO is
an investigational device. Limited by United States Law to
investigational use.
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
ForesightThis press release contains forward-looking
statements within the meaning of federal securities laws, including
statements regarding the potential utilities, values, benefits and
advantages of Foresight Diagnostics CLARITY MRD platform and its
PhasED-Seq technology which involve risks and uncertainties that
could cause the actual results to differ materially from the
anticipated results and expectations expressed in these
forward-looking statements. These statements are based on current
expectations, forecasts and assumptions, and actual outcomes and
results could differ materially from these statements due to a
number of factors. The forward-looking statements in this press
release are based on information available to Foresight Diagnostics
as of the date hereof, and Foresight Diagnostics disclaims any
obligation to update any forward-looking statements provided to
reflect any change in its expectations or any change in events,
conditions, or circumstances on which any such statement is based,
except as required by law. These forward-looking statements should
not be relied upon as representing Foresight Diagnostics’ views as
of any date subsequent to the date of this press release.
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 “advance,”
“believes,” “targeted,” “anticipated, ” “potential,” “estimates,”
“likely to,” “expects,” “plans,” “designed to,” “can,” “become,”
“begin,” “build,” “may,” “could,” or “will,” including alternative
verb 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; the pace, timing and extent to which Allogene may enroll
patients in its clinical trials or release data from such trials;
the timing and ability to progress the ALPHA3 trial; 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 first line treatment; the potential
for cema-cel to successfully treat first line patients; the
potential for Allogene’s product candidates to be approved; the
potential benefits of the ALPHA3 trial and of AlloCAR T™ products,
including the potential for ALPHA3 to transform treatment of first
line LBCL; the ability of our product candidates to treat various
stages and types of cancers; Allogene’s ability to broaden patient
access to CAR T therapy; the incidence, severity and manageability
of side effects of allogeneic CAR T products; the potential of
ALPHA3 to demonstrate a meaningful improvement in event free
survival in patients treated with cema-cel relative to patients who
receive the current standard of care; the extent to which our
clinical trials will support regulatory approval of our product
candidates; the potential for off-the-shelf CAR T products; our
ability to 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 that ALPHA3 can mitigate or avoid
the risk of delivering unnecessarily intense therapy to patients;
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.
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. Foresight CLARITY™ IUO is for
research use only. It is not intended for diagnostic
procedures.
Allogene Media/Investor Contacts:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
Leslie BryantSenior Communications
ConsultantLeslie.Bryant@Allogene.com
Foresight Media/Investor Contacts:Sara HeadVP
of MarketingSara.head@foresight-dx.com
1 Kurtz, et al. 2021; Isbell, et al. 2024
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