12-06-2018

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

Aduro Biotech, 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.

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