Partial clinical hold for Aduro's Listeria candidates

Aduro Biotech Inc. (NASDAQ:ADRO) slipped $0.55 to $11.70 on Monday after it said FDA placed a partial clinical hold on trials evaluating candidates developed using the company's Listeria monocytogenes-based immunotherapy construct (LADD) platform. The hold will pause new patient enrollment in the studies, while patients already treated with LADD-based products will continue to receive treatment.

Aduro said FDA placed the hold after a blood culture sample from a pancreatic cancer patient in its Phase IIb ECLIPSE trial of CRS-207 tested positive for Listeria several months after treatment. CRS-207 is a live-attenuated strain of Listeria that expresses human mesothelin. The company said the patient was given antibiotics and that further blood cultures tested negative for Listeria. Aduro intends to propose revised study protocols to FDA this week. ...