Aduro Biotech announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to CRS-207 for the treatment of mesothelioma.

CRS-207 is being developed for patients with malignant pleural mesothelioma who have not received prior therapy and are not eligible for surgical resection. Patients are currently being enrolled in a single-arm Phase 1b clinical trial of CRS-207 in combination with standard-of-care chemotherapy.

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In October 2014, interim results were presented which demonstrated a 94% rate of disease control (partial response and stable disease) for the 16 treated, evaluable patients with response data. Specifically, 75% (12/16) had confirmed partial responses and 19% (3/16) experienced stable disease. At the time of the presentation, estimated progression-free survival was 7.5 months, with one patient on study for more than 19 months. That patient is currently receiving maintenance therapy with CRS-207 alone following the combination treatment with chemotherapy. Based on these results, Aduro opened an expansion cohort of up to a total of 40 patients and expects to finish enrollment in the study in 2015, with top-line results presented in 2016.

CRS-207 was previously granted Orphan Drug designation for the treatment of pancreatic cancer.

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