BERKELEY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) -- 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 Affairs
510 809 9264
Media Contact:
Susan Lehner
510 809 2137
press@aduro.com
