On October 17, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported 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 (Press release, Aduro Biotech, OCT 17, 2017, View Source [SID1234520976]). 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 1×108 or 1×109 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.
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.