Foghorn Therapeutics Announces First Patient Dosed in Phase 1 Combination Study of FHD-286 for Relapsed and/or Refractory AML

CAMBRIDGE, Mass., Aug. 31, 2023 (GLOBE NEWSWIRE) -- Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, today announced the first patient has been dosed in the Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory acute myelogenous leukemia (AML).

“Based on the broad differentiation effect previously seen in the single-agent escalation study, we believe FHD-286 has the potential to be a widely used therapeutic in AML,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. “We are pleased to announce that the first patient has been dosed in the AML combination study and anticipate having data in the second half of 2024.”

“We are excited about FHD-286’s potential to be a broad-based differentiation agent in AML and were highly encouraged by the Phase 1 monotherapy study, where FHD-286 demonstrated singe-agent activity across a broad range of genomic backgrounds,” said Courtney DiNardo, M.D., Associate Professor, Department of Leukemia, MD Anderson Cancer Center, and an investigator of the Phase 1 combination study. “Treatment with FHD-286, in combination with decitabine or cytarabine, has the potential to address a significant unmet need in AML that remains despite available options.”

As previously reported, in the Phase 1 monotherapy dose escalation study, reductions in both peripheral and bone marrow blast counts, as well as recoveries in absolute neutrophil count (ANC), were observed in a subset of heavily pre-treated relapsed and/or refractory patients, irrespective of mutational status. Across a broad range of patients, differentiation was observed both morphologically and/or through biomarkers. Additionally, patients with evaluable paired bone marrow biopsies demonstrated differentiation as measured by changes in CD11b+ cells, CD34+ cells, and other associated biomarkers. In addition, preclinical models with various combination agents including decitabine and cytarabine demonstrated improved survival benefit vs. the single-agent control arms.