Aduro Biotech Presents Preclinical Data Supporting Clinical Development of its Anti-APRIL Antibody, BION-1301, for the Treatm...
December 03 2016 - 12:00PM
Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with
three distinct immunotherapy technologies, today announced the
presentation of data from preclinical studies supporting the
clinical development of the company’s proprietary monoclonal
antibody (mAb) BION-1301, a humanized anti-APRIL (A
PRoliferation-Inducing Ligand) antibody for the treatment of
multiple myeloma. Data from these in vivo and in vitro
preclinical studies demonstrated that BION-1301 effectively
neutralized APRIL, preventing its binding to BCMA (B cell
maturation antigen), an essential receptor expressed on multiple
myeloma cells. Based on the mechanism of action and
anti-tumor activity observed in earlier preclinical studies with
the parental anti-APRIL antibody, hAPRIL.01A, BION-1301 has the
potential to inhibit multiple myeloma tumor growth, survival and
chemoresistance. These data, which will be highlighted in a
poster presentation (Poster #2112) at the 58th American Society of
Hematology Annual Meeting and Exposition, further underscore the
potential application of BION-1301 for use as a single agent, or in
combination with current standard of care therapies, for the
treatment of multiple myeloma.
“In patients with multiple myeloma, there is an overabundance of
APRIL, a ligand which plays a critical role in the proliferation of
multiple myeloma cells,” stated Andrea van Elsas, Ph.D., chief
scientific officer of Aduro Biotech Europe. “With BION-1301, which
was derived from Aduro’s proprietary B-select antibody platform, we
are blocking APRIL from binding to its target receptor, thereby
inhibiting the growth and survival of multiple myeloma cells.”
Dr. van Elsas continued, “Based on the data to be presented
later today, we believe BION-1301 represents a novel antibody with
a novel mechanism of action that has potential in the treatment of
multiple myeloma, alone or in combination regimens. We look
forward to advancing BION-1301 into clinical development in the
coming year in our effort to bring much needed new treatment
options to patients with multiple myeloma.”
Researchers conducted in vivo and in vitro studies in
preclinical models of multiple myeloma comparing anti-tumor
activity achieved with BION-1301 and its parental antibody,
hAPRIL.01A. Data from these studies demonstrate the successful
creation and functional characterization of BION-1301 as a novel
APRIL-neutralizing antibody.
In April 2016, Aduro announced the publication of a study
entitled, “APRIL and BCMA promote human multiple myeloma growth,
chemoresistance, and immunosuppression in the bone marrow
microenvironment,” by Kenneth Anderson, M.D. Ph.D., and Tai Yu-Tzu,
Ph.D. of the Dana-Farber Cancer Institute. The article appeared in
the June 2016 issue (Volume 127, Number 25) of the peer-reviewed
journal Blood. The publication elucidates the roles of BCMA
and its ligand APRIL in multiple myeloma, highlighting the
potential therapeutic use of an agent that targets APRIL and fully
blocks its interaction with its receptors. The authors
demonstrated through in vivo and in vitro preclinical studies that
the APRIL/BCMA ligand/receptor pair drives multiple myeloma tumor
growth and survival, and activates immunosuppressive mechanisms
that allow the tumor to thrive. Importantly, the studies
demonstrated that the parental antibody to BION-1301 halts tumor
growth and overcomes drug resistance to chemotherapeutic agents
lenalidomide and bortezomib in preclinical models.
About Multiple Myeloma Lymphocytes (B cells and
T cells) are the primary cell types within the immune system that
work together to fight infection and disease. As B cells respond to
normal infection in the body, they mature and change into plasma
cells, which in turn make antibodies that help the body attack
infection. While lymphocytes circulate throughout the body, plasma
cells remain primarily in the bone marrow. Multiple myeloma is a
blood cancer that occurs when malignant plasma cells proliferate
uncontrollably. Approximately 50,000 new cases of multiple myeloma
will be diagnosed in the United States and Europe each year. While
many new therapies have become available in recent years, multiple
myeloma remains incurable and significant unmet needs exist among
patients who relapse following, are resistant to, or cannot
tolerate currently available agents.
About APRIL and BION-1301 APRIL is a member of
the tumor necrosis factor (TNF) superfamily and is primarily
secreted by bone marrow and/or myeloid cells. APRIL is overproduced
in patients with multiple myeloma and binds to BCMA to stimulate a
wide variety of responses that promote multiple myeloma growth and
suppress the immune system so that the tumor cells are allowed to
proliferate. The team at Aduro Biotech Europe, in collaboration
with Jan Paul Medema, Ph.D. of the Amsterdam Medical Center,
developed BION-1301, a humanized antibody that blocks APRIL from
binding to its receptors, using Aduro’s B-select monoclonal
antibody platform. In preclinical studies, BION-1301 eliminated
malignant cells and reduced resistance to therapy in models of
multiple myeloma. In addition to multiple myeloma, APRIL’s role in
other cancers and in B cell dependent autoimmune and inflammatory
diseases indicate that BION-1301 may also be useful in treating
chronic lymphocytic leukemia, colorectal cancer and Berger’s
disease (caused by IgA antibody lodging in the kidneys).
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
pancreatic, 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 an anti-APRIL
antibody, such as BION-1301, the potential for our other product
candidates and technology platforms, and development plans for, 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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