Aduro Biotech, Inc. has announced that it has received a milestone payment from Janssen Biotech, Inc. for the acceptance of an Investigational New Drug (IND) Application by the U.S. Food and Drug Administration 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.
“We are extremely pleased with the progress Janssen has made with the development of ADU-741,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “In addition to FDA acceptance of INDs for ADU-741 and ADU-214 in the past two months, we recently received clearance from the FDA for our IND in which we are collaborating with Incyte to begin a clinical trial evaluating the combination of CRS-207 and epacadostat in patients with platinum-resistant ovarian, fallopian and peritoneal cancer. We are thrilled to work with top-notch collaborators like Janssen, Novartis and Incyte, which share the same dedication to the development of novel therapies for patients who need it the most.”
In May 2014, Aduro entered into an agreement granting Janssen an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform.
Under the agreement facilitated by Johnson & Johnson Innovation, Aduro has received an upfront payment, milestone payments associated with both the submission and the acceptance of the IND, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $345.5 million. In addition, Aduro is eligible to receive royalties on worldwide net sales upon successful launch and commercialization.