Large Molecule

FDA Puts Aduro Trial on Clinical Hold after Positive Listeria Tests

Oct 26, 2016

Street Insider

Aduro Biotech has received notice from the FDA that trials with investigational agents based on its LADD (Listeria-based immunotherapy construct) platform have been placed on partial clinical hold to pause new patient enrollment.

The Aduro trials are testing engineered immunotherapy platforms, based on live, attenuated, double-deleted Listeria monocytogenes.

The 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, which is suspected to be CRS-207.

The California-based biotech is working with the FDA to lift the partial hold so as to resume new patient enrollment in its trials.

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