Avrobio to start using plato in FAB-201, GAU-201 clinical trials in 2019
Plato consists of a four-plasmid vector system, automation of a closed cell manufacturing process and a conditioning regimen that utilizes therapeutic drug monitoring. Plato was designed to enhance the potency, safety, efficacy, and long-term durability of AVROBIO's gene therapies, and may additionally provide the capability to address CNS manifestations that accompany many lysosomal storage diseases. The company expects to have manufacturing capabilities at 200-liter bioreactor scale in the second half of 2019, with vector production capable of treating a substantial number of patients per year. The automated, closed cell manufacturing system is intended to improve quality and consistency between batches. In addition, its portability may allow for global production using lower-level clean rooms that are cost-effective and in ample supply around the world. The gene therapy product is cryopreserved to simplify logistics and allow convenient scheduling for patients. The company intends to start using plato in its FAB-201 and GAU-201 clinical trials in 2019.