On December 14, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that the European Medicines Agency (EMA) granted Orphan Drug Designation to CRS-207 and GVAX for the treatment of pancreatic cancer (Press release, Aduro BioTech, DEC 14, 2015, View Source [SID:1234508559]). Schedule your 30 min Free 1stOncology Demo! "We are extremely pleased to receive Orphan Drug Designation in the EU for CRS-207 and GVAX pancreas, which, taken together with our Breakthrough Designation granted by the U.S. Food and Drug Administration in the U.S., represent important regulatory milestones in our global strategy to develop new immunotherapies for this underserved population," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "As an integral step in our pursuit to bring this combination to patients with pancreatic cancer, we expect to report topline results from the ongoing Phase 2b ECLIPSE study evaluating this combination in the first half of 2016."
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To receive Orphan Drug Designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan Drug Designation provides incentives designed to facilitate development, including protocol assistance and scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.
Aduro has completed enrollment in the Phase 2b ECLIPSE trial of its novel LADD and GVAX immunotherapies being developed for the treatment of metastatic pancreatic cancer. The randomized, controlled three-arm trial enrolled 303 patients in the United States and Canada. Top line results are expected in the first half of 2016.
ECLIPSE was designed to evaluate the safety, immune response and efficacy of the combination immunotherapy of CRS-207 and GVAX Pancreas compared to chemotherapy. The trial also included a treatment arm to evaluate CRS-207 as a monotherapy. The primary endpoint of the trial is overall survival in the primary cohort of patients who have received two or more prior therapies for metastatic disease. A second cohort of patients who received one prior therapy for metastatic disease is also being evaluated.
About CRS-207
CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immuno-oncology platform that are designed to induce potent innate and adaptive immune responses. 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.
About GVAX Pancreas
GVAX Pancreas is one of a family of GVAX immunotherapies derived from human cancer cell lines that are genetically modified to express granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune system-stimulating cytokine. GVAX Pancreas is derived from human pancreatic cancer cell lines and is designed to activate specific T cell immunity to pancreatic cancer antigens, including mesothelin.