Aduro Biotech Announces Initiation of Phase 1b Clinical Trial in Non-Small Cell Lung Cancer under Janssen Strategic Partnership for ADU-214 in Combination with Nivolumab

BERKELEY, Calif., June 07, 2018 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ:ADRO) today announced the recent initiation of a Phase 1b study of ADU-214 (JNJ-64041757) in combination with nivolumab for the treatment of advanced lung cancer. ADU-214 is an immunotherapy based on Aduro’s live, attenuated double-deleted Listeria (LADD) technology platform in development for the treatment of advanced or metastatic non-small cell lung cancer. Janssen Biotech, Inc. (Janssen), Aduro’s license partner for ADU-214, is conducting the global trial.

“Based on single agent data from a Phase 1 dose-escalation study in patients with advanced-stage relapsed or refractory non-small cell lung presented at the 2017 International Association for the Study of Lung Cancer’s World Conference, Janssen made the decision to advance ADU-214 in combination with an anti-PD-1 checkpoint inhibitor,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “The initial data demonstrated that five out of nine patients treated with single agent ADU-214 achieved a best response of stable disease, with one patient having received 25 cycles of treatment at the time of data cut off.”

Isaacs continued, “The clinical data was supported by biomarker data demonstrating innate immune activation with transient cytokine increases in all patients, as well as induction of mesothelin-specific T cell immunity in a subset of patients, and we are pleased with Janssen’s progress for this program.”

The Phase 1b, multi-center study is designed to evaluate the safety and efficacy of ADU-214 in combination with nivolumab, Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor that Janssen secured through a 2016 clinical collaboration. The trial is enrolling patients with mesothelin-positive, relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung (see www.clinicaltrials.gov, identifier NCT03371381).

In October 2014, Aduro entered into an agreement with Janssen, granting an exclusive, worldwide license to ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on Aduro’s LADD immunotherapy platform. Under the agreement facilitated by Johnson & Johnson Innovation LLC, Aduro received a $30 million up-front payment and a $21 million milestone payment upon completion of various development activities, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $766 million. In addition, Aduro is eligible to receive royalties at a rate ranging from high single-digits to low teens on worldwide net sales upon successful launch and commercialization.

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-PD1 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 Janssen. 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, including ADU-214, our eligibility for future milestone payments or royalties and our ability to advance our drug development programs on our own or with our collaborators. In some cases you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “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 March 31, 2018, 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.