FDA slaps a full hold on Af­fimed's T cell en­gager in wake of a lethal re­ac­tion

The hold that Af­fimed ex­ecs put on one of their top de­vel­op­ment pro­grams at the be­gin­ning of last week is no longer vol­un­tary. The FDA has now fol­lowed up with a full hold, leav­ing reg­u­la­tors in the dri­ver’s seat on when — and if — they can re-start the ef­fort.

Ac­cord­ing to an SEC fil­ing, reg­u­la­tors told them of their de­ci­sion on Fri­day. 

The biotech halt­ed their Phase I pro­gram for the CD19/CD3-tar­get­ing T cell en­gager AFM11 af­ter the death of one pa­tient and a life-threat­en­ing re­ac­tion in two oth­ers in a high-dose group. The com­pa­ny has of­fered no ex­pla­na­tions of what hap­pened to the pa­tients, though cy­tokine storms have af­flict­ed pa­tients for years in cell ther­a­py stud­ies.

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