Aduro BioTech, Inc.’s ADRO shares gained 4.3% after the company announced that the European Medicines Agency has granted Orphan Drug designation to CRS-207 in combination with GVAX Pancreas for the treatment of patients with pancreatic cancer.
The combination is currently being evaluated in comparison to chemotherapy in the phase IIb ECLIPSE study for the treatment of patients with metastatic pancreatic cancer. Top-line results are expected in the first half of 2016. The study also includes an arm to evaluate CRS-207 as a monotherapy.
We note that the combination enjoys a Breakthrough Therapy and Orphan Drug designation in the U.S.
We remind investors that CRS-207 also being evaluated in a phase Ib study in combination with standard-of-care chemotherapy for the treatment of patients with unresectable malignant pleural mesothelioma (MPM). Top-line data from the study is expected in the first half of 2016. The company expects to initiate a phase III study on the combination in the first half of 2016.
In late November, CRS-207 received Orphan drug designation in the EU for MPM. The candidate also holds Orphan drug designation in the U.S. for the treatment of patients with mesothelioma.
Aduro currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT, each sporting a Zacks Rank #1 (Strong Buy).
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