The FDA slapped Foghorn’s phase 1 blood cancer gene therapy trial with a partial clinical hold following the death of a patient.
The trial paused is Foghorn’s dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The patient who died had potential differentiation syndrome, which has been previously linked with AML and MDS therapeutics that induce differentiation.
The Massachusetts-based biotech's FHD-286 is a small-molecule, enzymatic inhibitor of BRG1 and BRM, proteins that are key regulators of the chromatin system. The drug has shown anti-tumor activity in both blood and solid tumors.
The FDA has asked for more information regarding future risk mitigation, and a breakdown of clinical activity.
About the hold, Foghorn CEO Adrian Gottschalk said, “Patient safety remains our top priority. We appreciate the dialogue with the FDA and will work diligently with the agency to resolve the partial clinical hold in AML/MDS as soon as possible.”