FDA Breakthrough Therapy Designation: #49 For Pancreatic Cancer
Aduro BioTech, a California-based clinical-stage biotechnology company, announces July 21st that the company receives a FDA Breakthrough Therapy Designation (BTD). The BTD is for the company’s pancreatic cancer combination treatment that consists of CRS-207 and GVAX Pancreas immunotherapies. GVAX Pancreas is a “ … CRS-207 is one of a family of candidates based on Aduro Biotech’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induce a potent innate and T cell-mediated immune response …… GVAX vaccine derived from human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine.”
The BTD is based on results of a Phase II trial in metastatic pancreatic cancer patients which are presented at the beginning of 2014, at the ASCO Gastrointestinal Cancers Symposium conference. The clinical trial shows that the median overall survival of patients receiving the combination treatment is 6.1 months compared to 3.9 months for those patients receiving GVAX monotherapy. Aduro BioTech is planning on completing enrollment in a 240 patient Phase IIb clinical trial (ECLIPSE) by the end of 2015.
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