Aduro Biotech Announces Presentation of Phase 1 Data for LADD-based Immunotherapy at World Conference on Lung Cancer
October 17 2017 - 08:00AM
Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with
three distinct immunotherapy technologies, today announced that its
license partner, Janssen Biotech, Inc., presented a poster with
initial data from an ongoing first-in-human Phase 1 dose finding
trial to evaluate JNJ-64041757 (also known as ADU-214 ), a live,
attenuated double-deleted Listeria monocytogenes (LADD)-based
immunotherapy in development for the treatment of advanced or
metastatic non-small cell lung cancer. The data were presented at
the International Association for the Study of Lung Cancer’s World
Conference being held in Yokohama, Japan.
The Phase 1 first-in-human, open label dose-finding trial
included nine patients with advanced stage relapsed or refractory
non-small cell lung cancer. Patients were administered either 1x108
or 1x109 colony-forming units infused intravenously over one hour
every 21 days. Of the nine patients treated with JNJ-64041757
monotherapy, five experienced a best response of stable disease.
The maximum number of cycles administered to a single patient was
25 cycles at the time of the clinical data cut off. Additionally,
biomarker data showed evidence of activation of innate immunity
with transient cytokine increases in all patients as well as
induction of mesothelin-specific T cell immunity in a subset of
patients. The immunotherapy was generally well-tolerated with
transient mild to moderate adverse events, including headache,
nausea, pyrexia and vomiting.
“These are encouraging early data which we believe may support
clinical activity of our listeria-based immunotherapy for lung
cancer,” said Dirk Brockstedt, executive vice president of research
and development at Aduro Biotech. “We look forward to Janssen
initiating a combination trial of JNJ-64041757 with other agents,
based on synergistic combination data from preclinical mouse tumor
models.”
In October 2014, Aduro entered into its second agreement with
Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies
of Johnson & Johnson, granting an exclusive, worldwide license
to JNJ-64041757 and other product candidates engineered for the
treatment of lung cancer and certain other cancers based on its
novel LADD immunotherapy platform. Under the agreement facilitated
by the Johnson & Johnson Innovation center in California, Aduro
received a $30 million up-front payment and has received $21
million in milestone payments upon the completion of various
development activities. Aduro is eligible to receive future
development, regulatory and commercialization milestone payments up
to a potential total of $766 million. In addition, Aduro is
eligible to receive royalties at a rate ranging from high
single-digits to low teens on worldwide net sales upon successful
launch and commercialization.
About LADD LADD is Aduro’s proprietary platform
of live-attenuated double-deleted Listeria monocytogenes strains
that have been engineered to induce a potent innate immune response
and to express tumor-associated antigens to induce tumor-specific T
cell-mediated immunity.
About Aduro Aduro Biotech, Inc. is an
immunotherapy company focused on the discovery, development and
commercialization of therapies that transform the treatment of
challenging diseases. Aduro's technology platforms, which are
designed to harness the body's natural immune system, are being
investigated in cancer indications and have the potential to expand
into autoimmune and infectious diseases. Aduro's LADD technology
platform is based on proprietary attenuated strains of Listeria
that have been engineered to express tumor-associated antigens to
induce specific and targeted immune responses. This platform is
being developed as a treatment for multiple indications, including
mesothelioma, gastric, ovarian, lung and prostate cancers.
Additionally, a personalized form of LADD, or pLADD, is in Phase 1
development utilizing tumor neoantigens that are specific to an
individual patient’s tumor. Aduro's STING Pathway Activator
platform is designed to activate the STING receptor in immune
cells, resulting in a potent tumor-specific immune response.
ADU-S100 is the first STING Pathway Activator compound to enter the
clinic and is currently being evaluated in both a Phase 1
monotherapy study as well as a Phase 1b combination study with an
anti-PD1 immune checkpoint inhibitor. Aduro’s B-select monoclonal
antibody platform is comprised of a number of immune modulating
assets in research and preclinical development, including
BION-1301, an anti-APRIL antibody. Aduro is collaborating with
leading global pharmaceutical companies to expand its products and
technology platforms. 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 ADU-214 alone or
in combination with other agents, our eligibility to receive
additional milestone payments or royalties with respect to ADU-214,
our technology platforms, plans, and the potential for eventual
regulatory approval of our product candidates. In some cases, you
can identify these statements by forward-looking words such as
“may,” “will,” “continue,” “anticipate,” “intend,” “could,”
“project,” “seek”, “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, 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, 2017,
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.
Contact:Sylvia WheelerSVP, Corporate Affairs510 809 9264
Media Contact:Alexandra Santos510 809 9231press@aduro.com
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