Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that's a known problem for all drugs in this class.
The company presented Phase Ib data for magrolimab, a CD47 inhibitor, in AML and MDS. An interviewed executive and an investigator expressed particular excitement about complete responses in a poor-prognosis patient subset, in addition to the general AML population.
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Forty Seven's shares were up more than 60% on the Nasdaq following the news. The company's lead candidate is magrolimab, an immuno-therapy drug with a mechanism of action distinct from checkpoint inhibitors currently on the market.