On October 08, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that it has received a milestone payment from Janssen Biotech, Inc. for Aduro’s submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for ADU-214, a LADD immunotherapy in development for the treatment of non-small cell lung cancer (Press release, Aduro BioTech, OCT 8, 2015, View Source [SID:1234507677]). Schedule your 30 min Free 1stOncology Demo! The IND will enable Janssen, Aduro’s license partner for ADU-214, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-214.
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"We are pleased to support Janssen in their advancement of ADU-214 into clinical trials in non-small cell lung cancer," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe there is tremendous potential with our LADD immunotherapy platform and our partnerships, like this one with Janssen, supplement our own efforts and provide additional resources to evaluate the clinical value of our technology in multiple tumor types."
Janssen expects to initiate a Phase 1 trial by the end of 2015 to evaluate the safety and immunogenicity of intravenous administration of ADU-214 in patients with non-small lung cancer.
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 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 a milestone payment associated with submission of the IND, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $786.5 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.