Aduro Biotech Inc., a clinical-stage immunotherapy company, announced that it has received a milestone payment from Janssen Biotech Inc. for the acceptance of Aduro’s Investigational New Drug (IND) application by the US Food and Drug Administration for ADU-214, a LADD immunotherapy product candidate for the treatment of lung cancer.

Janssen, Aduro’s license partner for ADU-214, expects to initiate a multi-center phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-214 by the end of 2015.

“The acceptance of the IND marks an important milestone for Aduro, as ADU-214 will be the first immunotherapy compound to enter clinical trials through our license agreement with Janssen,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro.

“Lung cancer is the leading cause of cancer-related deaths worldwide and traditionally has been very difficult to treat. We believe ADU-214 may be an attractive alternative in combating this deadly disease.”

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 ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on Aduro’s novel LADD immunotherapy platform. Under the agreement facilitated by Johnson & Johnson Innovation center, Aduro received a $30 million up-front payment and a milestone payment associated with submission of the IND, and is eligible to receive future development, regulatory and commercialisation milestone payments up to a potential total of $786 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 commercialisation.

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.