Adaptive Biotechnologies Announces FDA Acceptance of Genentech’s Investigational New Drug Application for the First Neoantigen-Directed T-Cell Therapy Product in Oncology
May 09 2023 - 7:30AM
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 detect and
treat disease, today announced that the U.S. Food and Drug
Administration has accepted an investigational new drug (IND)
application submitted by its collaborator, Genentech, a member of
the Roche Group, for a T-cell receptor (TCR) based T-Cell Therapy.
This is the first TCR-based therapeutic product candidate to
advance into clinical development based on Adaptive’s collaboration
with Genentech in oncology.
“This IND acceptance reaffirms the value of our immune medicine
platform and Adaptive’s ability to identify and characterize
clinical grade, therapeutic T-cell receptors, which is the
cornerstone of our drug discovery capabilities,” said Chad Robins,
chief executive officer and co-founder, Adaptive Biotechnologies.
“We look forward to supporting Genentech’s world-class team of
scientists and drug developers to advance this potentially
life-saving therapy into the clinic for patients with solid
tumors.”
Under the terms of Adaptive and Genentech’s collaboration
agreement, Genentech has responsibility for clinical, regulatory
and commercialization efforts for any T-Cell Therapy product
candidate. Adaptive reiterates its full year revenue guidance in
the range of $205 to $215 million.
About Adaptive Biotechnologies and Genentech’s Cell
Therapy Collaboration In 2019, Adaptive Biotechnologies
and Genentech, a member of the Roche Group, entered into a
worldwide collaboration and license agreement to develop,
manufacture and commercialize novel neoantigen directed T-cell
therapies for the treatment of a broad range of cancers. The
collaboration combines Genentech’s global cancer immunotherapy
research and development leadership with Adaptive’s proprietary
T-cell receptor (TCR) discovery platform to accelerate a
transformational new treatment paradigm of tailoring cellular
therapy for each patient’s individual cancer.
About Adaptive BiotechnologiesAdaptive
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. 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. For more information, please
visit adaptivebiotech.com and follow us
on www.twitter.com/adaptivebiotech.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
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future operations.
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forward-looking statements contain these words. These statements
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actual results, levels of activity, performance or achievements to
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Discussion and Analysis of Financial Condition and Results of
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combination of facts and factors currently known by us and our
projections concerning 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
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except as required by law.
MEDIA CONTACT:Erica
Jones206-279-2423media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina Calzadilla, Vice
President, Investor Relations201-396-1687Carrie Mendivil, Gilmartin
Groupinvestors@adaptivebiotech.com
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