Foghorn Therapeutics isn’t having much luck with FHD-286. Only weeks after the FDA released a trial of the drug in two blood cancers from a clinical hold, the biotech has abandoned plans for the candidate in an eye tumor after taking a look at phase 1 data.
FHD-286 is an enzymatic inhibitor of BRG1 and BRM, two proteins that promote cancer cell growth. The company said data released today from a dose-escalation study in metastatic uveal melanoma showed that the drug “reinforces the safety and tolerability profile” of the candidate but will not be pursued further in this indication.
It’s not hard to see why. The trial assessed 73 patients with the retinal tumor who received one of nine different regimens including one of four different FHD-286 doses. The results were less than impressive, with just one patient showing a durable partial response over 16 months of treatment, while nine participants had stable disease. Reductions in tumors were seen in eight patients.
This is not the end of the road for FHD-286, however. While the FDA placed a phase 1 trial of the drug in multiple acute myelogenous leukemia (AML) and myelodysplastic syndrome on hold in May 2022 following the death of a patient with potential differentiation syndrome (MDS), the regulator greenlighted an amended version of the trial earlier this month.
Foghorn confirmed today that it plans to dose the first patient in a phase 1 study of FHD-286 in combination with the chemotherapies Dacogen or cytarabine in relapsed and/or refractory AML patients in the third quarter of the year.
The company has previously said that FHD-286 has demonstrated anti-tumor activity across a “broad range of malignancies including both hematologic and solid tumors.”
Today’s data “further support the safety and tolerability of FHD-286 and build on the previously disclosed AML/MDS data,” CEO Adrian Gottschalk said in a release. “However, Foghorn does not plan to pursue this indication on its own.”
As well as the trial in AML, the company will “continue to invest in our promising pre-clinical programs such as Selective-BRM, CBP, EP300, and ARID1B,” Gottschalk added.
Investors didn’t seem overly concerned by Foghorn’s news this morning, with the biotech’s shares sitting almost 6% down at $7.90 in premarket trading from a Tuesday closing price of $8.40.