Foghorn gives up on sole wholly owned clinical asset after phase 1 leukemia failure

Foghorn Therapeutics has finally given up on its only wholly owned clinical-stage candidate after the troubled cancer drug came up short in a phase 1 study in patients with acute myeloid leukemia (AML).

FHD-286 is an enzymatic inhibitor of BRG1 and BRM, two proteins that promote cancer cell growth. The candidate hasn’t had an easy ride through the clinic, with Foghorn previously abandoning plans to evaluate the drug as an eye tumor treatment after taking a look at phase 1 data.

A phase 1 trial of FHD-286 in AML and myelodysplastic syndrome was also placed on hold by the FDA for a year following the death of a patient with potential differentiation syndrome. The regulator greenlighted an amended version of the trial last year.

Now, the biotech has taken a peek at the data from this updated trial of FHD-286 in combination with the chemotherapy Dacogen and decided that it’s not worth pursuing FHD-286 in AML, either.

Despite objective clinical responses being observed in the study, these “did not meet the company’s threshold to continue development by Foghorn alone,” the biotech explained in a Dec. 16 release.

The company was keen to turn attention to its remaining programs, the most advanced of which is FHD-909. The phase 1-stage therapy for SMARCA4 mutant cancers is part of an Eli Lilly collaboration originating in 2021, when the Indianapolis Big Pharma handed over $300 million upfront and an $80 million equity investment for Foghorn's BRM-selective program, another undisclosed cancer target and three discovery programs.

The remainder of Foghorn’s programs remain in preclinical development.

“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,” Foghorn CEO Adrian Gottschalk said in the release.

Foghorn ended September with $267.4 million in cash and equivalents, which the company said today was enough to fund its operations into 2027.