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Aduro Biotech Announces Initiation of Phase 1 Study of ADU-741 for the Treatment of Prostate Cancer

BERKELEY, Calif., Dec. 21, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the first patient in the Phase 1 study of ADU-741 (also known as JNJ-64041809), a LADD immunotherapy product candidate for the treatment of prostate cancer, has been dosed. Janssen Biotech, Inc., is Aduro’s license partner for ADU-741. Janssen is conducting the study.

“Janssen has deep expertise in the development of therapeutics for prostate cancer and we are extremely pleased with the rapid advancement of ADU-741 into clinical trials,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “ADU-741 represents a highly-specific, multifaceted approach to stimulate the immune system to fight cancer and we believe it may offer a new and unique treatment alternative to improve the outcome of men suffering from metastatic castration-resistant prostate cancer. We are particularly excited about ADU-741, which represents a significant advancement of our LADD technology and utilizes our proprietary methods to express multiple antigens that are relevant to prostate cancer. By engaging in productive agreements with partners like Janssen, Novartis and Incyte, we expand the reach of our novel immuno-oncology platform and offset the development costs of our internal therapies, all of which we pursue for the ultimate goal of bringing new treatments to patients in need.”

The Phase 1 study will enroll approximately 40 patients with metastatic castration-resistant prostate cancer. The initial dose escalation portion of the trial, with two dose levels of ADU-741, will evaluate safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity. Additional information may be found at clinicaltrials.gov, using identifier NCT02625857.

About LADD

LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer), ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).

About Aduro

Aduro Biotech, Inc. is a clinical-stage 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, lung and prostate cancers, mesothelioma and glioblastoma. Aduro's cyclic dinucleotide (CDN) 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 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-741, plans and timing of Janssen’s Phase 1 clinical trial of ADU-741 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,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “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 the most recent Form 10-Q 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.

Contact: Sylvia Wheeler SVP, Corporate Affairs 510 809 9264 Media Contact: Angela Bitting 925 202 6211 Mike Beyer Sam Brown, Inc. 312-961-2502 press@aduro.com

Source:Aduro Biotech, Inc.