The FDA has sounded a warning about Foghorn Therapeutics’ blood cancer candidate FHD-286, putting a phase 1 clinical trial on a partial hold in response to the death of a patient with potential differentiation syndrome.
FHD-286 is an enzymatic inhibitor of BRG1 and BRM, two proteins that promote cancer cell growth. By blocking the proteins, Foghorn thinks its oral candidate may improve outcomes in patients with relapsed and refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). However, the FDA has pushed back the generation of data to support that hypothesis in response to a safety signal.
