Date: 2016-02-01
Type of information: Milestone
Compound: LADD immunotherapy platform including ADU-741, GVAX technology
Company: Aduro Biotech (USA - CA) Janssen Biotech, a J&J company (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: immunotherapy product/therapeutic vaccine/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. GVAX is a family of vaccines derived from human cancer cell lines, which are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine. Aduro’s GVAX portfolio includes vaccines for pancreatic, prostate, colon and breast cancers as well as multiple myeloma.
Disease: prostate cancer
Details: * On May 29, 2014, Aduro BioTech, announced that it has entered into an agreement granting Janssen Biotech an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform. Janssen will assume responsibility for all research, development, manufacturing, regulatory and commercialization activities for the licensed products. Under a separate agreement, Aduro has granted Janssen exclusive rights to Aduro’s GVAX technology for prostate cancer.
Financial terms: Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro is eligible to receive up to $365 million in upfront license fees and milestone payments upon achievement of defined development, regulatory and commercialization milestones, if multiple programs advance to commercialization, as well as tiered royalties on worldwide net sales.
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 December 16, 2015 , Aduro Biotech announced that it has received a milestone payment from Janssen Biotech for the acceptance of an Investigational New Drug (IND) Application by the FDA for ADU-741, a LADD immunotherapy product candidate for the treatment of prostate cancer. Janssen, Aduro’s license partner for ADU-741, plans to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 by the end of 2015. * On November 18, 2015, Aduro Biotech announced that it has received a milestone payment from Janssen Biotech, Inc. for Aduro’s submission of an Investigational New Drug (IND) Application to the FDA for ADU-741. The IND will enable Janssen, Aduro’s license partner for ADU-741, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-741 in patients with metastatic castration-resistant prostate cancer (mCRPC).
