BERKELEY, Calif., Jan. 19, 2017 (GLOBE NEWSWIRE) -- 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 pLADD
Personalized 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
