Foghorn Therapeutics Shifts Focus from Development Of Cancer Hopeful with Eye Cancer

Foghorn Therapeutics Inc FHTX announced the data from the Phase 1 dose escalation safety study of FHD-286 in metastatic uveal melanoma (mUM). 

These findings further validate the safety and tolerability profile of FHD-286. However, Foghorn does not intend to pursue FHD-286 to treat uveal melanoma.

The Phase 1 dose-escalation study of FHD-286 in metastatic uveal melanoma included 73 patients who had received a median of two prior therapies across nine different cohorts. 

The clinical data from the Phase 1 study supported the safety and tolerability of FHD-286. 

The most common treatment-related adverse events included dysgeusia, fatigue, AST increase, nausea/vomiting, dry mouth, and rash. Grade 3 or higher treatment-related events were mainly anemia, asthenia, ALP increase, hypokalemia, muscular weakness, and rash.

Out of the 73 patients, 47 had target lesions for evaluation. One patient demonstrated a durable partial response and remained on treatment for over 16 months, while nine patients achieved stable disease. 

Eight patients exhibited tumor reductions in target lesions. Circulating tumor DNA reductions supported the observed clinical activity. 

Preliminary data on immune modulation markers in the tumor microenvironment also indicated the potential for combination treatment with checkpoint inhibitors.

Foghorn intends to initiate a Phase 1 study of FHD-286 in combination with decitabine or cytarabine for relapsed and/or refractory AML patients, with the first patient scheduled to receive the treatment.

Earlier this month, the FDA lifted the clinical hold on the Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia (AML) and myelodysplastic syndrome. 

In May 2022, the FDA instituted a partial clinical hold on Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory AML and myelodysplastic syndrome, converted to a full clinical hold in August.

In April, The company paused enrollment on its Phase 1 trial of FHD-609 in patients with synovial sarcoma and SMARCB1-deleted tumors after a patient had a severe heart-related safety event.

Price Action: FHTX shares are down 0.42% at $8.37 on the last check Wednesday.