Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products, and Foresight Diagnostics (Foresight), the
leader in the development of ultra-sensitive liquid biopsy
circulating tumor DNA (ctDNA) detection today announced a strategic
partnership to develop a minimal residual disease (MRD) in-vitro
diagnostic (IVD) to determine eligibility in ALPHA3, the first
pivotal trial for first line (1L) consolidation treatment of large
B-cell lymphoma (LBCL).
The ALPHA3 trial uses Foresight’s investigational PhasED-Seq™
ctDNA-MRD platform to identify patients with MRD after 1L treatment
for LBCL. The study will evaluate whether such patients benefit
from consolidation with cemacabtagene ansegedleucel, or cema-cel
(previously known as ALLO-501A). If successful, cema-cel could
become part of the 1L treatment plan for newly diagnosed LBCL
patients who are at a high risk for recurrence. Start-up activities
for the ALPHA3 trial have been initiated.
“We knew that an ultra-sensitive ctDNA-based biomarker would be
crucial to accurately identify patients with minimal residual
disease whose cancer will likely recur. Foresight was the partner
we were waiting for due to PhasED-Seq’s robust evidence and
reputation as the most reliable and sensitive MRD assay in
development for LBCL,” said David Chang, M.D., Ph.D., President,
Chief Executive Officer and Co-Founder of Allogene. “The
combination of rapid, blood-based testing and an off-the-shelf
allogeneic CAR T creates a unique opportunity to deliver
consolidation therapy before cancer relapses. This will also allow
us to aim for broader patient access to this powerful modality by
making enrollment available in community centers where the
infrastructure to administer autologous therapies may not be
readily available.”
Although 1L R-CHOP is curative for many with LBCL, approximately
30% of patients who initially respond will later relapsei. The
standard of care after 1L treatment has been simply to “watch and
wait” for the disease to relapse. The reliance on radiographic
imaging, the current clinical standard for relapse detection, does
not allow effective consolidation approaches due to its limited
accuracyii. PhasED-Seq is an ultra-sensitive and specific,
plasma-based liquid biopsy that will enable cema-cel’s 1L
consolidation approach in ALPHA3 through early and accurate MRD
assessment beyond current radiographic imaging-based disease
assessmentiii.
Growing evidence also suggests improved outcomes and safety for
patients who are treated with CAR T when tumor burden is lowiv.
Cema-cel’s Phase 1 safety profile, with low rates of cytokine
release syndrome (CRS) and immune effector cell-associated
neurotoxicity syndrome (ICANS), already permits its use in the
outpatient setting in relapsed/refractory patients and may further
improve in patients with no radiological evidence of disease.
“Although CAR T therapy has shown promise in multiple cancer
indications, it has been relegated to later lines of treatment. The
combination of cema-cel’s speed to treatment, its favorable
efficacy and safety profile from the Phase 1 trial in later lines,
and the ability to pair it with an accurate biomarker has provided
the pathway to introduce CAR T into the first line LBCL treatment
setting. Importantly, it may allow cema-cel to consolidate response
in patients at high risk of relapse and in the community setting
where most first line patients are managed,” said Zachary Roberts,
M.D., Ph.D., Executive Vice President of Research & Development
and Chief Medical Officer of Allogene. “The partnership between
Allogene and Foresight Diagnostics brings all the necessary
components together for the first time. If successful, the
combination of cema-cel and Foresight’s IVD could mark a paradigm
shift in how LBCL patients are managed in the clinic.”
“We commend Allogene for pioneering ctDNA biomarkers and leading
the way toward personalized medicine. The ALPHA3 study showcases
their commitment to advancing patient care,” said Jake Chabon, PhD,
Chief Executive Officer, and Co-Founder of Foresight Diagnostics.
“Foresight is proud to deliver a technology that stands singular in
performance. We look forward to working alongside Allogene to
improve outcomes for patients with LBCL.”
About Foresight DiagnosticsForesight
Diagnostics is a privately held cancer diagnostics company and
CLIA-registered laboratory. The company has developed a novel
liquid biopsy testing platform for the measurement of minimal
residual disease (MRD) that is significantly more sensitive than
existing tests (with a detection limit below 0.0001%, or one
part-per-million). The improved sensitivity of the Foresight’s MRD
assays can provide actionable information to physicians and
biopharmaceutical companies to enable more personalized treatment
approaches for patients with solid tumors and hematologic
malignancies. For more information, please visit foresight-dx.com
and follow us on Twitter and LinkedIn.
About PhasED-SeqThe Foresight MRD platform is
based on the Phased variant Enrichment and Detection by Sequencing
(PhasED-Seq™) technology. PhasED-Seq lowers the error profile of
mutation detection in sequencing data by requiring the concordant
detection of two separate non-reference events in an individual DNA
molecule. By detecting more than one mutation, PhasED-Seq can more
accurately distinguish tumor-derived cell free DNA (i.e., ctDNA)
from healthy cell free DNA – enabling detection of ctDNA at levels
below one part-per-million (<0.0001%). PhasED-Seq has been
extensively tested in thousands of patient samples.
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 @AllogeneTx on X
(formerly Twitter) and LinkedIn.
About Cemacabtagene Ansegedleucel (Previously Known as
ALLO-501A)Cemacabtagene ansegedleucel, or cema-cel is a
next generation anti-CD19 AlloCAR T™ investigational product
for the treatment of large B cell lymphoma (LBCL). This product
candidate is currently being studied in an ongoing potentially
pivotal Phase 2 trial in relapsed/refractory (r/r) LBCL. The ALPHA3
pivotal Phase 2 trial in first line (1L) consolidation for the
treatment of LBCL is expected to begin mid-2024. 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.
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," “projects,”
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could,"
“would,” “suggests,” "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:
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 Allogene’s product candidates to be
approved; the potential benefits of AlloCAR T products; 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 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 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 SEC, including without
limitation under the “Risk Factors” heading in its Annual Report on
Form 10-K for the year ended December 31, 2022, and in its
Quarterly Report on Form 10-Q for the quarter ended September 30,
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.
Allogene’s investigational oncology products utilize
TALEN® gene-editing technology pioneered and owned by
Cellectis. ALLO-501 and cemacabtagene ansegedleucel (previously
known as ALLO-501A) are anti-CD19 AlloCAR T™ investigational
products being 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 cemacabtagene
ansegedleucel in the U.S.
AlloCAR T™ is a trademark of Allogene Therapeutics,
Inc.PhasED-Seq™ is a trademark of Foresight Diagnostics.
Foresight Contact:Sara
Headpress@foresight-dx.com
Allogene Media/Investor Contact:Christine
CassianoEVP, Chief Corporate Affairs & Brand Strategy
OfficerChristine.Cassiano@allogene.com
Additional Allogene Media Contacts:Leslie
BryantLeslie.Bryant@allogene.com
Madeleine GoldsteinMadeleine.Goldstein@allogene.com
i Tilly H, Morschhauser F, Sehn LH, Friedberg JW, et al.
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell
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Co Ting Keh, L. et al. Enhanced detection of minimal residual
disease by targeted sequencing of phased variants in circulating
tumor DNA. Nat Biotechnol 39, 1537–1547 (2021).
https://doi.org/10.1038/s41587-021-00981-w Roschewski M, Lindenberg
L, Mena E, et al. Blood. 2023;142(Supplement 1):192-192.
doi:10.1182/blood-2023-180007iii Kurtz, D.M., Soo, J., Co Ting Keh,
L. et al. Enhanced detection of minimal residual disease by
targeted sequencing of phased variants in circulating tumor DNA.
Nat Biotechnol 39, 1537–1547 (2021).
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Gonen M, Wang X, Sénéchal B, Curran KJ, Sauter C, Wang Y,
Santomasso B, Mead E, Roshal M, Maslak P, Davila M, Brentjens RJ,
Sadelain M. Long-Term Follow-up of CD19 CAR Therapy in Acute
Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):449-459.
doi: 10.1056/NEJMoa1709919. PMID: 29385376; PMCID: PMC6637939
Wudhikarn K, Tomas AA, Flynn JR, Devlin SM, Brower J, Bachanova
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2023 Jun 5. PMID: 37272527
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