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Gilead’s Magrolimab Hit With Third Clinical Hold, This Time In AML

 
• By Ayisha Sharma

Gilead’s novel immune checkpoint inhibitor candidate, magrolimab, has been placed on a partial clinical hold by the US Food and Drug Administration in acute myeloid leukemia, adding to a spate of recent setbacks for the therapy that are chipping away at investor confidence.  

silhouette of man trying to hold up row of dominoes falling down
Magrolimab Could Succeed In AML Despite The Hold • Source: Shutterstock
Key Takeaways:

  • The hold stops new patients enrolling into Gilead’s ENHANCE-2 and ENHANCE-3 trials in AML.

  • No reason was provided but for previous holds, the firm cited suspected serious adverse reactions in the treatment arm, likely cytopenias.

  • AML has become a key indication for magrolimab after a pivotal MDS trial was discontinued last month.

Gilead Sciences, Inc.’s first-in-class immunotherapy candidate, magrolimab, has been hit with a partial clinical hold from the US Food and Drug Administration in acute myeloid leukemia (AML), less than...

Magrolimab is designed to block the inhibitory CD47-signal regulatory protein interaction (SIRPα), impeding the 'don’t eat me' signal of cancer cells and enabling macrophages and other phagocytes to identify and...

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