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Aduro Biotech Announces First Patient Dosed in Phase 1 Study of ADU-214 for the Treatment of Lung Cancer

BERKELEY, Calif., Dec. 10, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced the start of the Phase 1 study of ADU-214 (also known as JNJ-64041757), a LADD immuno-oncology therapy for the treatment of lung cancer, with the dosing of the first patient in the trial. Janssen Biotech, Inc., Aduro’s license partner for ADU-214, is conducting the multi-center study.

“We are extremely pleased to see the first immuno-oncology therapy resulting from our license agreement with Janssen enter the clinic,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “With more than 200,000 new diagnoses this year and over 400,000 people living with lung cancer in the United States alone, new therapeutics are desperately needed. We believe ADU-214 may offer new hope to patients suffering from this aggressive disease.”

The Phase 1 study will evaluate intravenous administration of ADU-214 in patients with advanced or metastatic non-small cell lung cancer. The trial is expected to enroll up to 40 patients, approximately 12 of whom will participate in the dose escalation portion of the trial where two dose levels of ADU-214 will be evaluated for safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity in an additional 30 patients. Additional information may be found at clinicaltrials.gov, using identifier NCT02592967.

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-214, plans and timing of Janssen’s Phase 1 clinical trial of ADU-214 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 press@aduro.com

Source:Aduro Biotech, Inc.