Auduro Biotech Gains FDA Breakthrough Therapy Designation for Immunotherapy
Aduro BioTech, Inc., a clinical-stage biotechnology company, reports that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its pancreatic cancer combination treatment that consists of its CRS-207 and GVAX Pancreas immunotherapies.
According to the FDA, a breakthrough therapy designation is for a drug that treats a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies. A breakthrough therapy designation is one of four avenues provided by FDA to expedite drug development for therapies that treat serious or life-threatening conditions. Breakthrough includes all of the fast track program features and provides more intensive FDA guidance involving senior FDA staff. As with fast track, breakthrough status provides eligibility for rolling review and priority review of the company's biologics license application when submitted.
​CRS-207 is one of a family of product candidates based on Aduro's live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induce a potent innate and T cell-mediated immune response. CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, and gastric cancers.
GVAX Pancreas is one of a family of GVAX vaccines derived from human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating facto, an immune-stimulatory cytokine. GVAX Pancreas also expresses mesothelin.
Aduro BioTech, Inc. is a private, clinical-stage biotechnology company focused on immunotherapy for cancer. Aduro has ongoing clinical trials with its LADD platform in pancreatic cancer, mesothelioma and high-grade glioma and its immunotherapies are in development in non-small cell lung cancer, ovarian cancer and prostate cancer. The company is also developing clinical candidates using novel small molecules that activate the intracellular STING receptor, a central mediator of the innate immune response.
In May 2014, Aduro entered into an agreement granting Janssen Biotech, Inc. 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, Janssen has responsibility for all research, development, manufacturing, regulatory, and commercialization activities for the licensed products. Under a separate agreement, Aduro granted Janssen exclusive rights to Aduro's GVAX technology for prostate cancer. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Source: Aduro BioTech
