Michael Amoroso, Precision BioSciences CEO

With eyes on first al­lo­gene­ic CAR-T ap­proval, Pre­ci­sion touts 100% re­sponse in 's­mall niche' pop­u­la­tion

Pre­ci­sion Bio­Sciences has grand reg­u­la­to­ry am­bi­tions for its lead pro­gram: first al­lo­gene­ic CAR-T ther­a­py on the mar­ket, but the biotech will have to shore up safe­ty con­cerns of its drug as four deaths were re­port­ed in a Phase I/IIa tri­al.

En route to meet­ing with the FDA lat­er this year on po­ten­tial reg­is­tra­tion strat­e­gy, the North Car­oli­na biotech is out with new in­ter­im Phase I/IIa clin­i­cal da­ta on its prized pos­ses­sion, dubbed PB­CAR0191. The an­ti-CD19 can­di­date is be­ing test­ed in pa­tients with re­lapsed or re­frac­to­ry ag­gres­sive lym­phomas.

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