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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