Adaptive and AbbVie Partner Across Multiple Myeloma Trials to Measure Minimal Residual Disease Using the clonoSEQ® Assay
December 09 2019 - 8:00AM
Adaptive Biotechnologies Corporation (Nasdaq:ADPT) today announced
a multi-year, global collaboration agreement with AbbVie (NYSE:
ABBV) to utilize Adaptive’s next-generation sequencing (NGS)-based
clonoSEQ® Assay to assess minimal residual disease (MRD)
status in response to venetoclax across multiple myeloma (MM)
clinical trials.
“Adaptive is thrilled to partner with AbbVie to support the
clinical development and potential regulatory approval of
venetoclax in multiple myeloma,” said Chad Robins, CEO and
co-founder of Adaptive Biotechnologies. “This partnership supports
the growing use of clonoSEQ in drug development as an accurate,
reliable method to assess response to new treatments that can
meaningfully improve patient care.”
MRD is a measure of the amount of cancer in the body,
specifically the very small number of cancer cells that remain
during or after treatment. MRD testing can be useful to see if a
patient is responding to treatment or if the cancer has come back.
It is performed as a series of tests throughout a patients cancer
journey.
Venetoclax is a first-in-class small molecule selective B-cell
lymphoma-2 (BCL-2) inhibitor being studied in investigational
trials for the treatment of MM patients. Adaptive and AbbVie will
evaluate the depth and duration of response to venetoclax by using
Adaptive’s clonoSEQ Assay to measure and monitor MRD negativity in
MM-treated patients. clonoSEQ is the first and only MRD test
authorized by the U.S. Food and Drug Administration (FDA) to detect
and monitor MRD in MM and B-Cell acute lymphoblastic leukemia (ALL)
using DNA from bone marrow samples.
About the
clonoSEQ Assay
The clonoSEQ Assay was granted de novo
designation and marketing authorization by FDA for the detection
and monitoring of minimal residual disease (MRD) in patients with
multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL)
using DNA from bone marrow samples. clonoSEQ is the first and only
FDA-authorized in vitro diagnostic assay for MRD testing. It is
also the first clinical diagnostic powered by immunosequencing to
receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary
immunosequencing 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 detect 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 are
strongly associated with MRD levels measured by the clonoSEQ Assay
in patients diagnosed with ALL and MM. clonoSEQ testing is
covered by Medicare and an expanding list of private payors in
alignment with the FDA label.
clonoSEQ is a single-site assay performed at
Adaptive Biotechnologies. It is also available as a
CLIA-regulated laboratory developed test (LDT) service for use in
other lymphoid cancers. 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 Biotechnologies
Adaptive Biotechnologies 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 to develop
products in life sciences research, clinical diagnostics, and drug
discovery. We have two commercial products, and a robust clinical
pipeline to diagnose, monitor and enable the treatment of diseases
such as cancer, autoimmune conditions and infectious diseases. Our
goal is to develop and commercialize immune-driven clinical
products tailored to each individual patient. For more information,
please visit
adaptivebiotech.com.
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 Adaptive
Biotechnologies’ partnership with Amgen, 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. In some cases, you can
identify forward-looking statements by the words “may,” “will,”
“expect,” “plan,” “believe,” “ongoing” or the negative of these
terms or other comparable terminology, although not all
forward-looking statements contain these words. These statements
involve risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements to
be materially different from the information expressed or implied
by these forward-looking statements. These risks, uncertainties and
other factors are described under "Risk Factors," "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" and elsewhere in the documents the Company files with
the Securities and Exchange Commission (the "SEC") from time to
time. We caution you that forward-looking statements are based on a
combination of facts and factors currently known by us and our
projections of the future, about which we cannot be certain.
As a result, the forward-looking statements may not prove to be
accurate. The forward-looking statements in this press release
represent our views as of the date hereof. We undertake no
obligation to update any forward-looking statements for any reason,
except as required by law.
ADAPTIVE MEDIA Beth Keshishian 917-912-7195
media@adaptivebiotech.com
ADAPTIVE INVESTORS Lynn
Lewis or Carrie Mendivil 415-937-5405
investors@adaptivebiotech.com
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