Aduro Biotech Announces Promising Preclinical Data that Validate Anti-CTLA-4 Antibody ADU-1604

BERKELEY, Calif., Nov. 10, 2017 -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced data from preclinical studies with ADU-1604, the company’s humanized anti-CTLA-4 monoclonal antibody.  Data from these in vitro and in vivo studies demonstrate the potency of ADU-1604 and its ability to inhibit tumor growth and enhance T cell-dependent antibody responses.  These data, which will be highlighted later today in a poster presentation (Poster #335) at the 32^nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC), underscore the potential application of ADU-1604 for the treatment of multiple cancer types, either as monotherapy or in combination with other therapies.   

“These data from preclinical studies of ADU-1604, a novel anti-CTLA-4 product candidate derived from our proprietary B-select antibody platform, are encouraging and provide support to file an Investigational New Drug Application to advance ADU-1604 into clinical studies,” stated Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech.  “As a company with multiple programs and proprietary technology platforms, we are well positioned to leverage our product candidates, as monotherapies and in rational combinations, to develop new treatment options for patients in need.”

Presentation Title:  Characterization of a novel differentiated anti-CTLA-4 antibody (ADU-1604) in vitro and in vivo
Researchers conducted in vitro and in vivo studies comparing ADU-1604 to benchmark anti-CTLA-4 antibodies 10D1 (‘ipilimumab’) and CP-675,206 (‘tremelimumab’). Data from these studies demonstrate that ADU-1604 binds to a unique epitope on a human CTLA-4 (hCTLA-4) and is at least comparable to benchmarks in functionality. Data from in vivo studies using a well-established humanized mouse model of non-small cell lung cancer and a non-human primate model, demonstrate that ADU-1604 inhibits tumor growth and enhances T cell responses, respectively. Further, proof of concept studies in syngeneic mouse models demonstrate that anti-CTLA-4 further enhances anti-tumor activity when used in combination with ADU-S100 (also known as MIW815), Aduro’s lead investigational STING agonist, and in combination with Aduro’s proprietary immunotherapy platform of live-attenuated double-deleted Listeria monocytogenes strains (LADD).   

About CTLA-4
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 (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. Aduro’s CTLA-4 antibody is being advanced through IND-enabling studies.

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 in Phase 1 development 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 both a Phase 1 monotherapy study as well as a Phase 1b combination study with an anti-PD1 immune checkpoint inhibitor. 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 potential for ADU-1604 alone or in combination with other therapies, our ability to leverage our product candidates, our technology platforms, plans, 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,” “seek”, “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 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 September 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           
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510 809 9264             

Media Contact:
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