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.
Read the Street Insider coverage