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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER