Aduro Biotech Announces Presentation of Phase 1 Data for LADD-based Immunotherapy at World Conference on Lung Cancer
Source: Nasdaq GlobeNewswire / 17 Oct 2017 08:01:21 Eastern Standard Time
BERKELEY, Calif., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced that its license partner, Janssen Biotech, Inc., presented a poster with initial data from an ongoing first-in-human Phase 1 dose finding trial to evaluate JNJ-64041757 (also known as ADU-214 ), a live, attenuated double-deleted Listeria monocytogenes (LADD)-based immunotherapy in development for the treatment of advanced or metastatic non-small cell lung cancer. The data were presented at the International Association for the Study of Lung Cancer’s World Conference being held in Yokohama, Japan.
The Phase 1 first-in-human, open label dose-finding trial included nine patients with advanced stage relapsed or refractory non-small cell lung cancer. Patients were administered either 1x108 or 1x109 colony-forming units infused intravenously over one hour every 21 days. Of the nine patients treated with JNJ-64041757 monotherapy, five experienced a best response of stable disease. The maximum number of cycles administered to a single patient was 25 cycles at the time of the clinical data cut off. Additionally, biomarker data showed evidence of activation of innate immunity with transient cytokine increases in all patients as well as induction of mesothelin-specific T cell immunity in a subset of patients. The immunotherapy was generally well-tolerated with transient mild to moderate adverse events, including headache, nausea, pyrexia and vomiting.
“These are encouraging early data which we believe may support clinical activity of our listeria-based immunotherapy for lung cancer,” said Dirk Brockstedt, executive vice president of research and development at Aduro Biotech. “We look forward to Janssen initiating a combination trial of JNJ-64041757 with other agents, based on synergistic combination data from preclinical mouse tumor models.”
In October 2014, Aduro entered into its second agreement with Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to JNJ-64041757 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform. Under the agreement facilitated by the Johnson & Johnson Innovation center in California, Aduro received a $30 million up-front payment and has received $21 million in milestone payments upon the completion of various development activities. Aduro 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.
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.
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-214 alone or in combination with other agents, our eligibility to receive additional milestone payments or royalties with respect to ADU-214, 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 June 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.
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