Aduro Biotech Announces First Patient Dosed in Phase 1 Study of ADU-S100 for the Treatment of Cutaneously Accessible Tumors

Seattle, Washington, UNITED STATES

BERKELEY, Calif., May 12, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the first patient has been dosed in a Phase 1 trial for ADU-S100 (also known as MIW815), a novel STING (Stimulator of Interferon Genes) pathway activator. Activation of the STING pathway in tumors has been shown to be a critical step to initiate an innate response that may lead to a systemic adaptive tumor-specific immune response. Novartis, Aduro’s collaborator for STING pathway activator compounds in the field of oncology, is conducting the study. The achievement of this milestone triggers a $35 million milestone payment from Novartis to Aduro.

“We are thrilled to embark on this landmark Phase 1 study, which we believe is the first clinical trial to specifically target the STING pathway. ADU-S100 (MIW815) has the potential to induce an anti-tumor immune response that is unique to the treated individual, an approach that potentially offers the benefits of a personalized therapy but using an off-the-shelf small molecule,” said Thomas Dubensky, Jr., Ph.D., chief scientific officer of Aduro. “ADU-S100 is the first compound to enter the clinic under our collaboration with Novartis, and through this Phase 1 study, we look forward to gaining insight into the safety, tolerability and initial efficacy for several different types of cancer. We have now advanced two differentiated immuno-oncology platforms into the clinic: ADU-S100, with the start of this trial, and our LADD listeria-based immunotherapy strains in clinical studies in multiple indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma.”

In preclinical models, direct activation of the STING pathway through intratumoral administration of ADU-S100 (MIW815) overcame immune system suppression within the tumor microenvironment, resulting in significant anti-tumor response. These preclinical studies, which were published in Cell Reports, demonstrated that injecting tumors with ADU-S100 (MIW815) induced profound regression of diverse established tumors in mice, both in the injected tumors and distal, untreated lesions. Importantly, treatment of a single tumor initiated a systemically effective T cell response that prevented outgrowth of untreated tumors in other areas of the body (metastases). The ADU-S100-initiated response was durable and provided lasting immunologic memory and anti-tumor protection.

The Phase 1, multicenter, dose escalation study, which includes dose expansion into designated indications, will enroll patients with cutaneously accessible metastatic solid tumors or lymphomas who are in need of other treatment alternatives. The trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ADU-S100 (MIW815). For more information about the clinical trial, please visit and use identifier NCT02675439.

In March 2015, Aduro entered into a collaboration with Novartis for the worldwide research, development and commercialization of novel immuno-oncology products derived from Aduro’s STING pathway activator platform. Under the terms of the agreement, Aduro received $200 million upon signing and an additional $50 million equity investment from Novartis. In addition to the $35 million milestone payment triggered by this Phase 1 trial initiation, Aduro is eligible to receive up to an additional $465 million in development and regulatory milestones if all stated objectives of the collaboration are achieved. Aduro will lead commercialization activities and will book sales in the United States for any products developed and commercialized pursuant to this collaboration, with Novartis leading commercialization activities in all other regions. The companies will share in profits, if any, in the United States, Japan and major European countries, and Novartis will pay Aduro a mid-teens royalty for sales in the rest of the world.

About the Tumor Microenvironment
The tumor microenvironment is the cellular environment in which the tumor exists, and, along with cancerous cells, includes support cells, immune cells, surrounding blood vessels, and the extracellular matrix. The tumor cells and the surrounding microenvironment are closely related and interact constantly. Tumors influence the microenvironment by releasing signals that promote tumor growth, immune tolerance and immune suppression. When tumors initially form, the body’s immune system recruits and activates a host of immune cells to fight the invading tumor. However, in cases where cancer develops, tumors are eventually able to evade the immune system by changing their microenvironment to inhibit the ability of the immune system to recognize and destroy the tumor thus allowing for tumor outgrowth and formation of metastasis.

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
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. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, ovarian, lung and prostate cancers, mesothelioma and glioblastoma. Aduro's STING Pathway Activator platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. 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

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 ADU-S100 and STING pathway activators generally, plans and timing of Novartis’ Phase 1 clinical trial of ADU-S100, potential future milestone payments and the potential for eventual regulatory approval, commercialization and launch of our product candidates. In some cases, you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “potentially, “anticipate,” “intend,” “could,” “would,” “plan,” “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 dependence on our lead product candidate, CRS-207, and GVAX Pancreas, 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 March 31, 2016 which is on file with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. 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.


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