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.
The mishap occurred just weeks after Genentech signed up to partner with the company on its separate NK cell tech. That work is continuing at Affimed, which has taken investors on a roller coaster ride of ups and downs.
The switch from voluntary to formal FDA hold is not a technicality. In recent years regulators have proven both quick to lift a hold — in Juno’s case, disastrously fast — or stubbornly insistent on keeping drugs sidelined indefinitely. It can also take some time to resume testing at trial sites after a full hold.
Affimed, unlike some US biotechs that have faced similar situations, hasn’t sought to reassure investors that it can resolve the issue quickly, saying only that it plans to fully evaluate the situation first.
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