Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of piv­otal da­ta on Au­to­lus Ther­a­peu­tics’ CAR-T is in, and ex­ecs are ready to plot a path to mar­ket.

With an over­all re­mis­sion rate of 70% at the in­ter­im analy­sis fea­tur­ing 50 pa­tients, the re­sults set the stage for a BLA fil­ing by the end of 2023, said CEO Chris­t­ian Itin.

Per­haps more im­por­tant­ly — giv­en that Au­to­lus’ drug, obe-cel, is go­ing af­ter an in­di­ca­tion that Gilead’s Tecar­tus is al­ready ap­proved for — the biotech high­light­ed “en­cour­ag­ing safe­ty da­ta” in the tri­al, with a low per­cent­age of pa­tients ex­pe­ri­enc­ing se­vere im­mune re­spons­es.

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