Adaptive Biotechnologies Enters Partnership for Use Of clonoSEQ® as Preferred MRD Test for Drug Development Across Amgen’s...
September 17 2019 - 8:00AM
Adaptive Biotechnologies Corporation (Nasdaq:ADPT) today announced
it has entered into a global agreement with Amgen for the use of
Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay
to assess minimal residual disease (MRD) across multiple drug
development programs within the Amgen hematology portfolio. Under
the terms of the four-year agreement, Adaptive will receive annual
development fees in addition to sequencing payments and regulatory
milestones in exchange for providing MRD testing and analysis for
ongoing and future clinical trials.
“We are excited to continue working with Amgen as their
preferred partner to support the development and regulatory
approval of novel blood cancer treatments,” said Chad Robins, chief
executive officer and co-founder of Adaptive Biotechnologies. “This
pan-portfolio partnership reflects Amgen’s confidence in the role
that standardized NGS MRD testing with clonoSEQ plays in
demonstrating drug efficacy in clinical trials and in day-to-day
patient management.”
The partnership, which began in 2016 to assess MRD in acute
lymphoblastic leukemia, demonstrates the increasing utility of MRD
assessment in the clinic. Adaptive will leverage data generated
under this partnership to continue building robust evidence that
supports MRD as a validated measure of patient outcomes across
multiple novel treatments and blood cancers.
"It is critical to know a patient’s MRD status because treating
to MRD negativity has been shown to drive better clinical outcomes
for patients in a variety of blood cancers," said Gregory Friberg,
M.D., vice president of global development at Amgen. “Standardized,
highly sensitive, molecular detection of MRD using clonoSEQ
supports the development of potential cancer therapies that can
help patients with blood cancer live longer.”
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.
MEDIA CONTACT:Beth KeshishianDirector,
Corporate Communications 917-912-7195media@adaptivebiotech.com
INVESTOR CONTACT:Lynn Lewis or Carrie
Mendivil415-937-5405investors@adaptivebiotech.com
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