On December 16, 2024 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines to treat serious diseases by correcting abnormal gene expression, reported that it has made the decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia (AML) (Press release, Foghorn Therapeutics, DEC 16, 2024, View Source [SID1234649122]). Foghorn is evaluating partnerships and ISTs (Investigator Sponsored Trials) to advance FHD-286. The Company will prioritize its proprietary pipeline and Lilly collaboration programs, including the clinical-stage selective SMARCA2 (BRM) inhibitor FHD-909 (LY4050784).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
As of September 30, 2024, the Company had $267.4 million in cash, cash equivalents and marketable securities. Its cash runway supports the Company into 2027.
In the Phase 1 dose escalation trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML, objective clinical responses were observed by standard response criteria. However, the observed response rate did not meet the Company’s threshold to continue development by Foghorn alone. Foghorn expects to report the results at a medical conference in 2025.
"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." said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "Our pipeline of potential medicines represents significant opportunities in oncology with the potential for therapeutic expansion. We want to thank the clinical investigators, the patients, and their families for their participation in the FHD-286 clinical trial."
About FHD-286
FHD-286 is a highly potent, first-in-class, selective, allosteric, and orally available small-molecule, enzymatic inhibitor of SMARCA2 (BRM) and SMARCA4 (BRG1), two highly similar proteins that are the ATPases, or the catalytic engines, of the BAF complex, one of the key regulators within the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies, including both hematologic and solid tumors.
About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.