Aduro BioTech has been awarded breakthrough therapy designation by the US Food and Drug Administration for its pancreatic cancer combination immunotherapy.

The designation which consists of Aduro’s CRS-207 and GVAX Pancreas immunotherapies, is based on a 93-patient Phase II trial in pancreatic cancer patients which showed that median overall survival of those receiving the combination was 6.1 months compared to 3.9 months for those on GVAX monotherapy. A Phase IIb trial is currently being conducted in North America involving 240 patients.

Aduro chief executive Stephen Isaacs said the firm is happy to get BTD “and the high degree of FDA collaboration toward advancement of our programme that it confers”. He added that the designation “underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat”.

A couple of months ago, Aduro signed a prostate cancer pact with Johnson & Johnson Innovation which could be worth up to $365 million, plus tiered royalties. Last month, it closed a $55 million financing in which J&J participated.