Aduro Biotech Announces Clinical Collaboration with Merck to Evaluate the Combination of Aduro’s CRS-207 with Merck’s KEYTRUDA® (Pembrolizumab) for the Treatment of Mesothelioma

BERKELEY, Calif., May 17, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, announced today the expansion of its clinical collaboration with Merck (known as MSD outside the United States and Canada) to include an additional Phase 2 clinical trial. The companies will investigate the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease progressed following prior treatment. Earlier this year, Aduro announced a Phase 2 clinical collaboration with Merck, through a subsidiary, to evaluate the combination of CRS-207 with pembrolizumab for the treatment of gastric cancer.

“Data from our ongoing Phase 1 clinical trial of CRS-207 with standard chemotherapy as frontline treatment for malignant pleural mesothelioma have been very encouraging, including disease control in 94 percent of patients treated with the CRS-207/chemotherapy combination,” said Natalie Sacks, M.D., chief medical officer at Aduro.  “Based on these clinical data, as well as data from preclinical studies that demonstrate synergistic activity of CRS-207 and anti-PD-1 therapy, we look forward to initiating a Phase 2 trial to evaluate the CRS-207/pembrolizumab combination in patients with malignant pleural mesothelioma who have failed prior treatment.” 

The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with previously treated MPM.  The trial is expected to involve approximately 35 patients who have failed one to two prior treatments. 

About Malignant Pleural Mesothelioma
Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen. Malignant pleural mesothelioma, which affects the thin balloon-shaped lining of the lungs, is the most common form of this disease and accounts for approximately 13,000 cases a year in the United States, European Union and Japan. MPM is an aggressive disease with a poor prognosis. Most MPM patients are not candidates for surgical resection. Currently, there is no U.S. Food and Drug Administration-approved therapy for second- or third-line treatment of MPM.  

About LADD and CRS-207
LADD is Aduro's proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate an innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. CRS-207, the company’s lead LADD product candidate, has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers. 

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, ovarian, lung and prostate cancers. Additionally, a personalized form of LADD, or pLADD, is being developed 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 a Phase 1 study in patients with cutaneously accessible metastatic solid tumors or lymphomas. 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 combination of CRS-207 with pembrolizumab for the potential treatment of mesothelioma and gastric cancer, the potential for our technology platforms, plans, the timing of our planned clinical 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,” “anticipate,” “intend,” “could,” “project,” “expect,” “targeted” 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-QK for the quarter ended March 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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Kenilworth, NJ, USA.

Contact:
Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264

Media Contact:
Susan Lehner
510 809 2137
press@aduro.com