Pre­ci­sion Bio­Sciences to meet with FDA af­ter tout­ing al­lo­gene­ic CAR-T win

Pre­ci­sion Bio­Sciences is now tout­ing new da­ta from a Phase I/II tri­al, say­ing that it has iden­ti­fied a dos­ing reg­i­men that it be­lieves will al­low the North Car­oli­na biotech to move its CAR-T in­to a mid-stage study.

Pre­ci­sion on Wednes­day shared up­dat­ed da­ta for az­er­cab­ta­gene za­preleu­cel (az­er-cel), the biotech’s lead can­di­date and al­lo­gene­ic CAR-T ther­a­py that tar­gets CD19. It re­port­ed a 58% over­all re­sponse rate and 41% com­plete re­sponse rate in a Phase I/IIa tri­al with 61 pa­tients with non-Hodgkin lym­phoma, across mul­ti­ple dos­es and lym­phode­ple­tion reg­i­mens, as of May 30.

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