Aduro joins the exclusive group of companies, so far only the big pharma, that have a successful trail of immunooncology candidates.
Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.
An FDA breakthrough tag entitles Aduro to a speedy review and access to senior agency staff as it works through the regulatory process with CRS-207 and GVAX, two immunotherapies designed to battle pancreatic cancer in tandem.
The regulatory victory comes on the heels of positive Phase II data for the combination, in which Aduro's cocktail beat out GVAX alone in 93 patients with metastatic pancreatic cancer. Median overall survival on the combo came in at 6.1 months, a statistically significant improvement over GVAX's 3.9 months.
Now Aduro is working through an expanded Phase IIb trial, enrolling about 240 patients into three treatment arms: one receiving the combination treatment, one taking CRS-207 alone and another on standard chemotherapy. The study's primary endpoint is overall survival, and Aduro hopes it'll back up the safety, immune response and efficacy CRS-207 and GVAX have demonstrated thus far.
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