BERKELEY, CA, USA I December 16, 2015 I Aduro Biotech, Inc. (ADRO) today 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 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.
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. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer), ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).
About Aduro
Aduro Biotech, Inc. is a clinical-stage immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, lung and prostate cancers, mesothelioma and glioblastoma. Aduro’s cyclic dinucleotide (CDN) platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.
SOURCE: Aduro Biotech
Post Views: 172
BERKELEY, CA, USA I December 16, 2015 I Aduro Biotech, Inc. (ADRO) today 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 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.
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. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer), ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).
About Aduro
Aduro Biotech, Inc. is a clinical-stage immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, lung and prostate cancers, mesothelioma and glioblastoma. Aduro’s cyclic dinucleotide (CDN) platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.
SOURCE: Aduro Biotech
Post Views: 172
