Adaptive Biotechnologies Announces New Translational Collaboration to Measure Minimal Residual Disease with clonoSEQ® Assay Across BeiGene’s Lymphoid Malignancy Pipeline
07 11월 2023 - 9:30PM
Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial
stage biotechnology company that aims to translate the genetics of
the adaptive immune system into clinical products to diagnose and
treat disease, today announced a multi-year, global translational
collaboration with BeiGene to assess minimal residual disease (MRD)
using clonoSEQ® assay technology across the company’s pipeline of
treatments for patients with lymphoid malignancies.
“Adaptive is pleased to partner with BeiGene to support the
clinical development and potential regulatory approval of their
investigational therapies in lymphoid malignancies,” said Mary Pat
Lancelotta, Senior Vice President, BioPharma at Adaptive
Biotechnologies. “MRD status has strong prognostic value, and by
integrating the measure into clinical studies our partners can more
quickly and efficiently evaluate and advance novel
therapeutics.”
MRD assessment is playing a growing role in clinical trials for
lymphoid malignancies by providing an early measure of treatment
response and serving as a potential endpoint, which may enable
novel therapies to be made available to patients sooner. As the
first and only standardized test authorized by the U.S. Food and
Drug Administration (FDA) for MRD assessment in bone marrow from
patients with multiple myeloma or B-cell acute lymphoblastic
leukemia (B-ALL) and blood or bone marrow from patients with
chronic lymphocytic leukemia (CLL), Adaptive’s clonoSEQ assay
technology is the test of choice among drug developers. It has been
included in global, label-enabling studies for a multitude of
therapies approved over the past several years and is also now
widely adopted in the clinic. It is used at all 33 National
Comprehensive Cancer Network (NCCN) centers, and as data supporting
its clinical utility mount, its use is also growing in the
community setting.
This multi-year agreement will cover existing and future
programs and adds to Adaptive’s growing list of translational
collaborations with biopharmaceutical companies. As part of the
collaboration, MRD status based on Adaptive’s clonoSEQ assay may be
used as an endpoint in certain clinical trials to assess the depth
and duration of response to BeiGene’s investigational medicines in
patients with lymphoid malignancies. Adaptive will receive an
upfront payment and will be eligible to receive future milestone
payments upon achievement of specific regulatory milestones in
certain geographies. Specific financial terms of the agreement will
not be disclosed.
About the clonoSEQ AssayThe clonoSEQ assay is
the first and only FDA-cleared in vitro diagnostic (IVD) test
service to detect minimal residual disease (MRD) in bone marrow
from patients with multiple myeloma (MM) or B-cell acute
lymphoblastic leukemia (B-ALL) and blood or bone marrow from
patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing
for diffuse large B-cell lymphoma (DLBCL) patients is currently
available for clinical use as a laboratory-developed test (LDT)
performed at Adaptive's CLIA-certified lab in Seattle, WA. Medicare
covers clonoSEQ in these four indications and is aligned with
clinical practice guidelines which support assessing MRD at
multiple time points throughout therapy to monitor treatment
response and help predict patient outcomes.
The clonoSEQ assay leverages Adaptive Biotechnologies’
proprietary immune medicine platform to identify and quantify
specific DNA sequences found in malignant cells, allowing
clinicians to assess and monitor MRD during and after treatment.
The assay provides standardized, accurate, and sensitive
measurement of MRD that allows physicians to predict patient
outcomes, assess response to therapy over time, monitor patients
during remission, and predict potential relapse. Clinical practice
guidelines in hematological malignancies recognize that MRD status
is a reliable indicator of clinical outcomes and response to
therapy, and clinical outcomes have been shown to be strongly
associated with MRD levels measured by the clonoSEQ assay in
patients diagnosed with CLL, MM, ALL and DLBCL.
For important information about the FDA-cleared uses of
clonoSEQ, including the full intended use, limitations, and
detailed performance characteristics, please visit
www.clonoSEQ.com/technical-summary.
About Adaptive BiotechnologiesAdaptive
Biotechnologies (“we” or “our”) is a commercial-stage biotechnology
company focused on harnessing the inherent biology of the adaptive
immune system to transform the diagnosis and treatment of disease.
We believe the adaptive immune system is nature’s most finely tuned
diagnostic and therapeutic for most diseases, but the inability to
decode it has prevented the medical community from fully leveraging
its capabilities. Our proprietary immune medicine platform reveals
and translates the massive genetics of the adaptive immune system
with scale, precision and speed. We apply our platform to partner
with biopharmaceutical companies, inform drug development, and
develop clinical diagnostics across our two business areas: Minimal
Residual Disease (MRD) and Immune Medicine. Our commercial products
and clinical pipeline enable the diagnosis, monitoring, and
treatment of diseases such as cancer, autoimmune disorders, and
infectious diseases. Our goal is to develop and commercialize
immune-driven clinical products tailored to each individual
patient.Forward Looking Statements This press
release contains forward-looking statements that are based on
management’s beliefs and assumptions and on information currently
available to management. All statements contained in this release
other than statements of historical fact are forward-looking
statements, including statements regarding our ability to develop,
commercialize and achieve market acceptance of our current and
planned products and services, our research and development
efforts, and other matters regarding our business strategies, use
of capital, results of operations and financial position, and plans
and objectives for future operations.
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ADAPTIVE MEDIAErica Jones, Associate Director,
Corporate Communications206-279-2423media@adaptivebiotech.com
ADAPTIVE INVESTORSKarina Calzadilla, Vice
President, Investor
Relations201-396-1687investors@adaptivebiotech.com
Adaptive Biotechnologies (NASDAQ:ADPT)
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