Date: 2016-02-01
Type of information: Milestone
Compound: ADU-214 and other product candidates engineered
Company: Aduro Biotech (USA - CA) Janssen Biotech, a J&J company (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: immunotherapy product/cell therapy. LADD immuno-oncology platform 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.
Disease: lung cancer
Details: * On October 16, 2014, Aduro BioTech announced that it has entered into its second agreement with Janssen Biotech, 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, Janssen will have exclusive rights to develop and commercialize LADD product candidates in lung cancer and will assume responsibility for all research, development, manufacturing, regulatory and commercialization activities for the licensed products. Aduro may provide assistance in any of these areas upon request and will receive additional fees for these support activities. In May of this year, Aduro announced its first agreement with Janssen Biotech, Inc. granting the company an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform.
Financial terms: Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro will receive a $30 million up-front payment and is eligible to receive significant development, regulatory and commercialization milestone payments up to a potential total of $817 million. In addition, Aduro is eligible to receive high single-digit to double-digit tiered royalties on worldwide net sales upon successful launch and commercialization.
Latest news: * On February 1, 2016, Aduro Biotech announced that the company received $22.4 million in clinical development milestone payments from Janssen Biotech, the company’s license partner for ADU-214, ADU-741 and other products using Aduro’s LADD technology platform for the treatment of specific cancers. Janssen is responsible for all clinical development for the product candidates within the license agreements. In May 2014 and October 2014, Aduro entered into two separate agreements with Janssen, granting exclusive, worldwide licenses to ADU-741 and other product candidates engineered for the treatment of prostate cancer, and ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers, based on its novel LADD immunotherapy platform. * On October 29, 2015, Aduro Biotech 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 FDA 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. ADU-214 is the first Aduro's immunotherapy compound to enter clinical trials through its license agreement with Janssen. * On October 8, 2015, Aduro Biotech announced that it has received a milestone payment from Janssen Biotech, for Aduro’s submission of an Investigational New Drug (IND) Application to the FDA for ADU-214, a LADD immunotherapy in development for the treatment of non-small cell lung cancer. 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. 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.
