Aduro Biotech Announces First Patient Dosed in Phase 2 Study of ADU-S100 (MIW815) in Combination with KEYTRUDA® (pembrolizum...
04 September 2019 - 10:30PM
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
first patient has been dosed in a Phase 2 clinical trial of
ADU-S100 (MIW815), a novel STING pathway activator, in combination
with KEYTRUDA® (pembrolizumab), an approved anti-PD-1 antibody, as
a first-line treatment for recurrent or metastatic head and neck
squamous cell carcinoma (HNSCC).
“The dosing of the first patient in the Phase 2 clinical study
of ADU-S100 in combination with pembrolizumab marks an important
advancement for Aduro as we shift from heavily pre-treated,
heterogenous patient populations to earlier lines of treatment for
patients with specific tumor types,” said Dimitry S.A. Nuyten,
M.D., Ph.D., chief medical officer of Aduro. “There is increasing
evidence that the potential benefit from immunotherapies is greater
in patients with fewer prior therapies. With the recent FDA
approval of pembrolizumab as first-line treatment for patients with
metastatic or unresectable, recurrent HNSCC whose tumors express
PD-L1 [Combined Positive Score (CPS) ≥1], we look forward to
continuing the progress of our clinical program by investigating
the potential synergistic benefit ADU-S100 may provide as a
combination treatment option.”
The Phase 2, open-label, multicenter trial, which is part of an
ongoing research and development collaboration with Novartis, is
designed to evaluate the efficacy and safety of ADU-S100 (MIW815)
administered intratumorally in combination with pembrolizumab in
the first-line setting. The planned population will consist of 33
adults with PD-L1 positive recurrent or metastatic head and neck
cancer (see www.clinicaltrials.gov, identifier NCT03937141).
About STING Pathway Activator TechnologyThe
Aduro-proprietary STING pathway activator product candidates,
including ADU-S100 (MIW815), are synthetic small molecule immune
modulators that are designed to target and activate human STING.
STING is generally expressed at high levels in immune cells,
including dendritic cells. Natural activation of STING is not
always sufficient to prevent the growth and spread of cancer cells.
In preclinical models, ADU-S100 (MIW815) directly activates STING
to further amplify the natural anti-tumor response. Once activated,
the STING receptor initiates a profound innate immune response
through multiple pathways, inducing the expression of a broad
profile of cytokines, including interferons and chemokines. This
subsequently leads to the development of a systemic tumor
antigen-specific T cell adaptive immune response.
Aduro’s lead molecule, ADU-S100 (MIW815), is the first
therapeutic in development specifically targeting STING. In
collaboration with Novartis, ADU-S100 (MIW815) has been tested in a
Phase 1 clinical trial as a single agent and is currently being
investigated in a Phase 1 clinical trial in combination with
ipilimumab as well as in a Phase 1b combination trial with
spartalizumab (PDR001), an investigational anti-PD-1 monoclonal
antibody. These studies are enrolling patients with cutaneously
accessible, advanced/metastatic solid tumors or lymphomas. ADU-S100
(MIW815) is also being investigated in a Phase 2 clinical trial in
combination with pembrolizumab, an approved anti-PD-1 antibody. The
trials are evaluating the ability of ADU-S100 (MIW815) to activate
the immune system and recruit specialized immune cells to attack
the injected tumor, leading to a broad immune response that seeks
out and kills distant metastases.
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 patients with
cutaneously accessible metastatic solid tumors or lymphomas.
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 intentions or current expectations concerning, among
other things, the potential for our therapies, the progress of our
clinical programs, including the patient population for our Phase 2
trial, our ability to investigate the potential synergistic benefit
ADU-S100 as a combination treatment option and our ability to
expand and drive our product pipeline alone or with collaborators.
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,
early or preliminary clinical trial results may not be predictive
of future results, 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 technologies 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, 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 June 30, 2019, which is on file with the
Securities and Exchange Commission. 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.
Investor Relations Contact: |
Media Contact: |
Noopur
Liffick |
Aljanae
Reynolds |
510-809-2465 |
510-809-2452 |
investors@aduro.com |
press@aduro.com |
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