FDA Lifts Hold on Aduro Immunotherapy Trials

Nov. 22, 2016

Aduro Biotech announced that the FDA has lifted the partial clinical hold on studies evaluating Aduro's investigational agents based on its LADD (live, attenuated double-deleted) immunotherapy platform.

In October, Aduro received notice from the FDA that a partial hold was initiated following notification to the FDA that a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient who presented with gastrointestinal symptoms tested positive for Listeria.

With the partial hold lifted, the company can resume patient enrollment, however the drugmaker has to revise study protocols in accordance with the FDA’s guidelines.

Aduro says it is now on track to initiate a phase II study utilizing the LADD-based therapy CRS-207, in combination with an anti-PD-1 compound, for the treatment of mesothelioma in the first half of 2017.

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