Aduro Biotech Announces Milestone Achieved under Merck Collaboration for Initiation of Phase 2 Trial of Anti-CD27 Agonist MK-...
07 February 2020 - 8:15AM
Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage
biopharmaceutical company focused on developing therapies targeting
the Stimulator of Interferon Genes (STING) and A Proliferation
Inducing Ligand (APRIL) pathways for the treatment of cancer,
autoimmune and inflammatory diseases, today announced that the
company earned a $10.0 million development milestone payment under
its worldwide licensing agreement with Merck (known as MSD outside
the United States and Canada) for the initiation of a Phase 2
clinical trial of MK-5890, an anti-CD27 agonist, in non-small cell
lung cancer (NSCLC).
“We are thrilled Merck is continuing to advance MK-5890 through
development with the initiation of a Phase 2 clinical trial in
NSCLC,” said Andrea van Elsas, Ph.D., chief scientific officer of
Aduro. “The achievement of this milestone would not be possible
without the efforts of the exceptional team we built at Aduro
Biotech Europe and the B-select technology that created several
monoclonal antibodies, including MK-5890 and BION-1301, an
anti-APRIL antibody we are currently developing for IgA
nephropathy.”
The Phase 2 trial is designed to assess the efficacy and safety
of pembrolizumab in combination with MK-5890 in patients with
advanced squamous or non-squamous NSCLC that have been previously
treated with anti-PD-L1 therapy (see www.clinicaltrials.gov,
identifier NCT04165096). The study is one of three pembrolizumab
substudies being conducted under one pembrolizumab umbrella master
protocol (MK-3475-U01).
About CD27 and Aduro’s Anti-CD27 AntibodyCD27
is a co-stimulatory receptor expressed on different immune cells,
such as T-lymphocytes and NK (natural killer) cells. It has been
recognized as having an important role in priming, enhancing and
sustaining a productive anti-cancer (CD8+ T-cell) adaptive immune
response. In preclinical studies, anti-CD27 activation was shown to
enhance T-cell response, which in combination with immune
checkpoint inhibition demonstrated the ability to achieve complete
tumor eradication.
In 2014, Merck, through certain affiliates, entered into a
worldwide license agreement for the development and
commercialization of CD27 antibody agonists. Aduro’s anti-CD27
antibody, which was identified with its proprietary B-select
monoclonal antibody technology, targets a functional epitope on
CD27 demonstrating potent activation of the CD27 co-stimulatory
pathway in pre-clinical studies. As a part of the worldwide license
agreement, and in addition to payments received, including the $15
million up-front payment, Aduro is eligible to receive future
development, commercial and net sales milestone payments. In
addition, Aduro is eligible to receive royalties in the mid-single
digits to low teens based on any net sales of the product, if it is
approved for marketing.
About Aduro Aduro Biotech, Inc. is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of therapies that are designed to
harness the body’s natural immune system for the treatment of
patients with challenging diseases. Aduro’s product candidates in
the Stimulator of Interferon Genes (STING) and A Proliferation
Inducing Ligand (APRIL) pathways are being investigated in cancer,
autoimmune and inflammatory diseases. ADU-S100 (MIW815), which
potentially activates the intracellular STING receptor for a potent
tumor-specific immune response, is being evaluated in a Phase 2
clinical trial in combination with pembrolizumab, an approved
anti-PD-1 antibody, as a first-line treatment for recurrent or
metastatic head and neck squamous cell carcinoma. BION-1301, a
first-in-class humanized IgG4 monoclonal antibody that fully blocks
APRIL binding to both the BCMA and TACI receptors, is being
evaluated in IgA nephropathy. Aduro is collaborating with a number
of leading global pharmaceutical companies to help expand and drive
its product pipeline. For more information, please visit
www.aduro.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include statements
regarding our current intentions or expectations concerning, among
other things, the potential for our technology, including MK-5890,
the continued advancement of our programs, our eligibility to
receive future milestones or royalties, and our collaborations with
leading global pharmaceutical companies to help expand and drive
our product pipeline. In some cases, you can identify these
statements by forward-looking words such as “may,” “will,”
“continue,” “anticipate,” “intend,” “could,” “project,” “expect” or
the negative or plural of these words or similar expressions.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results and events to differ materially from those anticipated,
including, but not limited to, our history of net operating losses
and uncertainty regarding our ability to achieve profitability, our
ability to develop and commercialize our product candidates, our
ability to use and expand our technology platforms to build a
pipeline of product candidates, our ability to obtain and maintain
regulatory approval of our product candidates, our ability to
operate in a competitive industry and compete successfully against
competitors that have greater resources than we do, our reliance on
third parties, the success of our restructuring, our ability retain
senior management and other highly qualified personnel, and our
ability to obtain and adequately protect intellectual property
rights for our product candidates. We discuss many of these
risks in greater detail under the heading “Risk Factors” contained
in our quarterly report on Form 10-Q for the quarter ended
September 30, 2019, on file with the Securities and Exchange
Commission (SEC), and our other filings with the SEC. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
Contact: |
Noopur
Liffick |
510-809-2465 |
investors@aduro.com
press@aduro.com |
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