Foghorn Therapeutics Inc. (Nasdaq: FHTX) has announced its decision to discontinue the independent development of FHD-286 in combination with decitabine for patients with relapsed or refractory acute myeloid leukemia (AML). This decision follows a Phase 1 dose escalation trial where, despite observing objective clinical responses, the response rate did not meet the company's threshold for continued independent development.
The company plans to explore potential partnerships and investigator-sponsored trials (ISTs) to further advance FHD-286. Moving forward, Foghorn will prioritize its proprietary pipeline and collaboration programs with Lilly, including the clinical-stage selective SMARCA2 (BRM) inhibitor, FHD-909 (LY4050784).
Strategic Shift and Financial Position
As of September 30, 2024, Foghorn Therapeutics reported having $267.4 million in cash, cash equivalents, and marketable securities. This financial stability is projected to support the company's operations into 2027, allowing for sustained investment in its prioritized programs.
"While clinical responses were observed for FHD-286, we will prioritize investment into our proprietary pipeline, including our Selective CBP program, Selective EP300 program, and ARID1B program, as well as our Lilly collaboration, including the clinical development of FHD-909," stated Adrian Gottschalk, President and Chief Executive Officer of Foghorn.
About FHD-286
FHD-286 is described as a highly potent, first-in-class, selective, allosteric, and orally available small-molecule enzymatic inhibitor of SMARCA2 (BRM) and SMARCA4 (BRG1). These proteins are ATPases and key components of the BAF complex, which plays a crucial role in the chromatin regulatory system. Preclinical studies have indicated that FHD-286 exhibits anti-tumor activity across a range of hematologic and solid tumors.
Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. In the United States, approximately 20,000 people are diagnosed with AML each year. AML is a heterogeneous disease characterized by multiple genetic mutations.
Future Plans
Foghorn Therapeutics anticipates presenting the complete results from the Phase 1 dose escalation trial of FHD-286 at a medical conference in 2025. The company remains focused on advancing its pipeline of potential medicines and exploring therapeutic opportunities in oncology.
