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Phase 1 pause
November 2018
SHARING OPTIONS:

HEIDELBERG, Germany—Affimed N.V. is temporarily halting the Phase 1 program for AFM11 by placing it on clinical hold, a decision based on the occurrence of serious adverse events in three patients: a death in the acute lymphoblastic leukemia study and two life-threatening events in the non-Hodgkin lymphoma study. AFM11 is a CD19/CD3-targeting T cell engager being evaluated in multiple cancer types, and a total of 33 patients have been treated so far in the two aforementioned studies. The patients who suffered serious adverse events were enrolled in the highest dose cohorts of each study. Affimed will work with global health authorities, the Safety Monitoring Committees and the clinical investigators for each study to review these events and decide on the future of the AFM11 program. The company plans to share its decision once an evaluation of the program is complete.

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