Aduro Biotech Enters into Exclusive License Agreement for Proprietary Neoantigen Identification Technology
January 19 2017 - 08:00AM
Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with
three distinct immunotherapy technologies, today announced an
exclusive license agreement with Stanford University for
state-of-the-art neoantigen identification technology developed by
Dr. Hanlee Ji, associate professor of medicine at Stanford.
Aduro will leverage its proprietary live, attenuated double-deleted
Listeria (LADD) immunotherapy platform to engineer personalized
LADD-based cancer therapies (pLADD) encoding multiple neoantigens
identified through this technology. The company plans to
initially evaluate pLADD for the treatment of cancers of the
gastrointestinal tract, including colorectal cancer, with a Phase 1
clinical trial expected to be initiated in 2017.
Pursuant to the terms of the agreement, Aduro received an
exclusive license to the proprietary bioinformatics algorithms and
computational workflows for neoantigen identification and
selection. The accurate identification of neoantigens, tumor
markers that are unique to an individual’s tumor, is believed to be
critical in the development of a patient-specific cancer
treatment. Aduro’s LADD technology, which has been shown in
clinical studies to remodel the tumor microenvironment, will be
used to create a patient-specific immunotherapy that is engineered
to enable the presentation of multiple selected neoantigens in
dendritic cells, with the aim of inducing a targeted, robust
anti-cancer immune response.
“We are excited to leverage the strength of Aduro’s LADD program
with this new expertise in identifying a patient’s unique
repertoire of cancer antigens to make personalized immunotherapies
a reality for patients in need,” said Thomas Dubensky Jr., Ph.D.,
chief scientific officer of Aduro. “We look forward to applying the
discoveries made possible with this highly sophisticated
computational approach to neoantigen identification, with the aim
to initiate a Phase 1 clinical trial later this year.”
About pLADDPersonalized LADD, or pLADD, is a
second-generation LADD technology that leverages the
immune-activating activity of the Listeria bacterial vector in
combination with neoantigens, which are unique, patient-specific
tumor markers exclusively expressed in an individual’s tumor cells.
Once administered, pLADD therapies are expected to mobilize the
immune system in two ways--first, through the immediate recognition
of the presence of Listeria as being foreign, and subsequently,
through a specific and customized immune attack on cells containing
the tumor neoantigens presented by pLADD. To create a
patient-specific pLADD therapy, a physician begins by removing
tumor cells from the patient. These cells are analyzed in order to
molecularly characterize (sequence) the tumor, including any
mutations that are unique to the patient’s own tumor cells.
Predictive algorithms for antigen processing are run to identify
pertinent tumor antigens. Aduro then creates a LADD strain that
includes the patient-specific neoantigens for administration.
An Investigational New Drug (IND) application has been cleared by
the U.S. Food and Drug Administration, and a Phase 1 trial
evaluating the safety and immunogenicity of pLADD in patients with
cancers of the gastrointestinal tract is planned for 2017.
Preclinical Data with pLADD Preclinical data
showed that pLADD induced a robust immune response, including broad
innate immune responses involving cytokines, chemokines, natural
killer, and gamma delta T cells, as well as antigen-specific
adaptive T cell responses (CD8+ and CD4+). In preclinical
models, pLADD remodeled the tumor microenvironment, whereby an
increase in infiltration of neutrophils, T cells and dendritic
cells was observed. The combination of pLADD with an anti PD-1
agent led to a sustained immune response and significant
prolongation of survival in these models.
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
ovarian, lung and prostate cancers, mesothelioma and glioblastoma.
Additionally, a personalized form of LADD, or pLADD, is being
developed utilizing tumor neoantigens that are specific to an
individual patient’s tumor. Aduro's STING Pathway Activator
platform is designed to activate the intracellular STING receptor,
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 a Phase 1 study in patients with
cutaneously accessible metastatic solid tumors or lymphomas.
Aduro’s B-select monoclonal antibody platform includes a number of
immune modulating assets in research and preclinical development.
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 pLADD and our
other technology platforms, plans, timing and the availability of
results of our clinical trials 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,” “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 inability 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 September 30, 2016, 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.
Contact:
Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264
Media Contact:
Susan Lehner
510 809 2137
press@aduro.com
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