Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with
three distinct immunotherapy technologies, announced today that the
first patient has been dosed in the Phase 1b dose escalation and
dose expansion clinical trial (see www.clinicaltrials.gov,
identifier NCT03172936) designed to evaluate the safety and
efficacy of ADU-S100 (also known as MIW815), a novel STING pathway
activator, in combination with PDR001, Novartis’ investigational
PD-1 checkpoint inhibitor, for the treatment of advanced/metastatic
solid tumors or lymphomas. The trial, which is being
conducted in collaboration with Aduro’s partner, Novartis, is
expected to enroll approximately 175 patients at sites located in
the United States, Europe, Canada, Australia and Japan.
“We are pleased with our early progress in the ongoing Phase 1
dose escalation trial of ADU-S100 as a single agent and are eager
to expand our investigation into a separate clinical trial to
evaluate the effect of ADU-S100 used in combination with the PDR001
checkpoint inhibitor,” said Natalie Sacks, M.D., chief medical
officer of Aduro Biotech. “As a leader in STING activation,
we look forward to gaining more insight into the potential
therapeutic application of this novel combination therapy.”
Clinical Design of Phase 1b ADU-S100
(MIW815)/PDR100 The Phase 1b multi-center, open-label
study is designed to evaluate the safety and efficacy of ADU-S100
(MIW815) in combination with PDR001 in patients with accessible
solid tumors or lymphomas. The trial will evaluate two
treatment schedules of ADU-S100 in dose escalation. One group
will receive a fixed dose of intravenous PDR001 on day 1 and an
intratumoral injection of ADU-S100 three times in a 28-day
cycle. Another group will receive a fixed dose of intravenous
PDR001 on day 1 and intratumoral injection of MIW815 (ADU-S100) on
day 1 of every 28-day cycle. Once the maximum tolerated dose
and/or recommended dose for expansion is determined, the expansion
part of the study will open.
Ongoing Phase 1 Dose Escalation Trial of ADU-S100
(MIW815) in Multiple Tumor Types In May 2016, Aduro
announced the initiation of the ongoing Phase 1, multicenter, dose
escalation study designed to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics and anti-tumor activity of
ADU-S100 (MIW815) in patients with cutaneously accessible
metastatic solid tumors or lymphomas (see www.clinicaltrials.gov,
identifier NCT02675439). The trial is ongoing.
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.
About Aduro/Novartis Collaboration In March
2015, Aduro and Novartis entered into a collaboration and license
agreement relating to the global research, development and
commercialization of immuno-oncology products derived from Aduro’s
proprietary STING pathway activator platform technology.
Under the terms of the agreement, Aduro received an upfront payment
from Novartis of $200 million and a $35 million development
milestone upon initiation of the Phase 1 trial for ADU-S100 in May
2016, and if all development and regulatory milestones are met, is
eligible to receive up to an additional aggregate amount of $465
million. The collaboration is guided by a joint steering
committee with both Aduro and Novartis having final decision making
authority regarding specified areas of development or
commercialization. Pending regulatory approval, Aduro
will lead commercialization activities and will book sales in the
United States for any products developed and commercialized
pursuant to this collaboration, and Novartis will lead
commercialization activities in all other regions. The companies
will share in profits, if any, in the United States, Japan and
major European countries. Novartis will pay Aduro a mid-teens
royalty for sales in the rest of the world. Aduro maintains
rights to its STING platform technology in all therapeutic areas
outside of oncology, including infectious disease and autoimmunity,
among others.
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 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 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 a Phase 1 study in
patients with cutaneously accessible metastatic solid tumors or
lymphomas. 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 combination of ADU-S100
(MIW815) with PDR001 for the Treatment of Solid Tumors and
Lymphomas, the expansion of the ongoing Phase 1 trial into
viscerally accessible lesions and the timing thereof, the potential
for our technology platforms, plans, timing and availability of
results of our clinical trials and those of our collaborators, the
timing and receipt of milestone payments, 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,” “targeted” 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
Wheeler
SVP, Corporate Affairs510 809 9264
Media Contact:Susan Lehner510 809 2137press@aduro.com
Aduro Biotech (NASDAQ:ADRO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aduro Biotech (NASDAQ:ADRO)
Historical Stock Chart
From Apr 2023 to Apr 2024