Press Release

Aduro Biotech Highlights Preclinical Data for Three Programs Reported at the American Association for Cancer Research Annual MeetingApril 17, 2018 4:02 p.m. ET

BERKELEY, Calif., April 17, 2018 (GLOBE NEWSWIRE) -- 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 inhibitors
On 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 application
On 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 myeloma
On 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-1301
Aduro 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.

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Jennifer Lew                                                               Aljanae Reynolds
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