Aduro Biotech, Inc. (NASDAQ:ADRO) today announced that data from
three of the company’s programs were presented at the American
Association for Cancer Research (AACR) this week. The poster
presentations detailed:
- Updated preclinical data for ADU-S100, a first-in-class small
molecule therapeutic in Phase 1 studies targeting the STimulator of
INterferon Genes (STING) pathway;
- New preclinical data for ADU-1604, an anti-CTLA-4 antibody
scheduled to enter clinical development in the second half of 2018;
and,
- Preclinical data for BION-1301, an anti-APRIL antibody
currently in a Phase 1/2 study for the treatment of patients with
multiple myeloma.
“These robust and new data continue to elucidate the diverse
mechanisms by which our immunotherapies may provide new therapeutic
alternatives for the large majority of patients that do not
currently benefit from available cancer immunotherapies,” said
Andrea van Elsas, Ph.D., chief scientific officer of Aduro. “For
ADU-S100, we’ve confirmed in preclinical models that signaling
through the STING pathway is critical to elicit tumor-reactive CD8+
T cells, the cornerstone of effective, durable and systemic
anti-tumor immunity as evident from rejection of distant tumors.
Importantly, these preclinical data show that adding checkpoint
inhibitors to an ADU-S100 treatment regimen can eradicate tumors
unresponsive to anti-PD-1 immunotherapy.”
Dr. van Elsas continued, “We also reported data on our
anti-CTLA-4 antibody, ADU-1604, and expect to initiate clinical
studies based on this data. In addition, our first-in-class
antibody BION-1301 blocks APRIL from binding to both BCMA and TACI
and may provide a differentiated approach to treating patients with
multiple myeloma who do not benefit from or are resistant to
current therapies. We look forward to confirming these data through
our ongoing Phase 1/2 clinical study.”
Presentation Title (Abstract #631): Intratumoral
activation of STING with a synthetic cyclic dinucleotide elicits
antitumor CD8+ T cell immunity that effectively combines with
checkpoint inhibitorsOn Sunday, April 15, 2018, Sarah
McWhirter of Aduro Biotech presented updated preclinical data
demonstrating that an optimized dosing regimen of ADU-S100
administered intratumorally activates acute innate immunity as well
as adaptive CD8+ T cells necessary and sufficient for systemic and
durable anti-tumor immunity. The data show that activation of the
STING pathway by ADU-S100 mediates local induction of type I
interferon and TNFα and subsequently CD8+ T cell induction to
stimulate an immune response sufficient to reduce or eliminate both
the injected and distal tumors.
In addition, combining ADU-S100 with checkpoint inhibitors
enhances the durable immunity even in tumors that are resistant to
anti-PD-1 treatment. Aduro and Novartis are evaluating ADU-S100 in
ongoing Phase 1 clinical studies, both as monotherapy for
cutaneously accessible tumors and in combination with PDR001, an
anti-PD-1 compound in advanced metastatic solid tumors and
lymphomas. Additional studies combining ADU-S100 and other
checkpoint inhibitors are planned.
Presentation Title (Abstract #1702): Assessment of
pharmacology and toxicology of anti-CTLA-4 antibody (ADU-1604) in
non-human primates and evolution of local and anti-CTLA-4
applicationOn Monday, April 16, 2018, Maaike Hendriks of
Aduro Biotech presented preclinical data demonstrating that
ADU-1604 binds a unique epitope on human CTLA-4 and was
well-tolerated, enhanced T cell activation and inhibited tumor
growth. Based on these data, Aduro plans to initiate a Phase 1
study in patients with advanced melanoma in the second half of
2018.
Presentation Title (Abstract #3780): Preclinical
pharmacokinetics, pharmacodynamics and safety of BION-1301, a
first-in-class antibody targeting APRIL for the treatment of
multiple myelomaOn Tuesday, April 17, 2018, John Dulos of
Aduro Biotech presented preclinical pharmacokinetic and
pharmacodynamic data initially announced at the American Society of
Hematology demonstrating that BION-1301 was well-tolerated. In
addition, the binding of BION-1301 to APRIL (A Proliferation
Inducing Ligand), a ligand for the receptors BCMA and TACI,
resulted in decreased IgA, IgG and IgM production in a
dose-dependent fashion. Aduro is evaluating BION-1301 in an ongoing
Phase 1/2 study in patients with multiple myeloma.
About STING Pathway Activator Platform The
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. 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, it is being tested in a Phase 1 monotherapy clinical
trial and in a Phase 1b combination study with PDR001, an anti-PD-1
compound. Both studies are enrolling patients with cutaneously
accessible, advanced/metastatic solid tumors or lymphomas. The
trials are evaluating the ability of ADU-S100 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 non-injected distant metastases. Initial clinical data
are expected in the second half 2018.
About ADU-1604 Cytotoxic
T‐lymphocyte‐associated protein 4 (CTLA‐4) is a negative regulator
of T cell responses and is an immune checkpoint. Blocking CTLA-4
using antibodies may produce an anti-tumor response by enhancing T
cell activation and their cancer cell killing activity in the
tumor. This therapeutic target has been clinically validated by
others in advanced melanoma. Aduro is developing a proprietary
humanized anti-CTLA-4 antibody called ADU-1604 that binds to a
unique epitope and its potency has been demonstrated in
vitro and in vivo. Based on preclinical studies, Aduro
believes that ADU-1604 when combined with innate and adaptive
immune cell stimulators such as STING agonists and cancer vaccines,
can display an amplified anti-tumor effect against poorly
immunogenic tumors. ADU-1604 is anticipated to enter clinical
development in the second half of 2018.
About BION-1301Aduro is currently evaluating
BION-1301, its most advanced proprietary B-select monoclonal
antibody, as a novel therapy for multiple myeloma. Despite new
treatments recently approved in multiple myeloma, this disease
remains incurable as patients relapse, or become resistant to,
currently-available therapies. In preclinical studies, Aduro has
established that A PRoliferation-Inducing Ligand (APRIL) plays a
crucial part in the protective bone marrow tumor microenvironment.
In these studies, APRIL, through the B cell maturation antigen
(BCMA), was shown to be critically involved in the survival,
proliferation and chemoresistance of multiple myeloma, and
upregulates mechanisms of immunoresistance, including PD-L1
upregulation. BION-1301, a humanized antibody that blocks APRIL
from binding to its receptors, has been shown in preclinical
studies to halt tumor growth and overcome drug resistance. In
addition, BION-1301 also demonstrated the ability to inhibit immune
suppressive effects of regulatory T cells via TACI but not BCMA in
multiple myeloma blood and bone marrow. BION-1301 is currently
being evaluated in a Phase 1/2 clinical study.
About Aduro Aduro Biotech, Inc. is an
immunotherapy company focused on the discovery, development and
commercialization of therapies that are intended to 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 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-PD-1 immune checkpoint inhibitor. Aduro’s
B-select monoclonal antibody platform, including BION-1301, an
anti-APRIL antibody, is comprised of a number of immune modulating
assets in research and development. Aduro's pLADD program is based
on proprietary attenuated strains of Listeria that have been
engineered to express tumor neoantigens that are specific to an
individual patient’s tumor. Other Listeria strains for lung and
prostate cancers are being advanced by a partner. 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 our technology,
plans, anticipated timing for the commencement and completion of
various clinical trials and the announcement of data relative to
these 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,” “plan,” “anticipate,” “intend,” “could,” “project,”
“seek,” “expect,” “position” 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
annual report on Form 10-K for the year ended December 31, 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. 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:
Media Contact:Jennifer Lew
Aljanae
ReynoldsChief Financial Officer
510 809 2452510 809 4816
press@aduro.com
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