Foghorn® Therapeutics Doses First Patient in Phase 1 Trial of FHD-909 for Non-Small Cell Lung Cancer

Foghorn® Therapeutics Inc., a clinical-stage biotech company focused on innovative treatments for severe diseases by correcting abnormal gene expression, has today announced the dosing of its first patient in a Phase 1 trial of FHD-909 (LY4050784). This trial targets cancers with SMARCA4 (BRG1) mutations, explicitly focusing on non-small cell lung cancer (NSCLC). FHD-909 is a first-in-class oral compound that selectively inhibits SMARCA2 (BRM) while sparing SMARCA4.

“FHD-909 is the first SMARCA2 selective inhibitor to enter the clinic. Dosing the first patient marks a significant milestone for the program and our collaboration with Lilly.FHD-909 has high selectivity over closely related SMARCA4, offering a promising synthetic lethality strategy for prevalent SMARCA4 mutations and their sensitivity to SMARCA2 inhibition in NSCLC and other solid tumours.

We look forward to continued advancement of FHD-909 in partnership with Lilly.” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn.

The open-label, multicenter Phase 1 trial will evaluate the safety, tolerability, and primary efficacy of FHD-909 in patients with locally advanced or metastatic solid tumours with SMARCA4 alterations.

Preclinical studies have shown that FHD-909 is a potent and selective inhibitor of SMARCA2, demonstrating significant anti-tumor effects as a monotherapy. In animal models with SMARCA2 mutations, FHD-909 exhibited good tolerability, modulated target genes effectively, and resulted in inhibition of tumour growth.

Additionally, in December 2021, Foghorn announced a strategic partnership with Lilly to develop new oncology treatments, which includes a 50/50 co-development and co-commercialization agreement for Foghorn’s Selective SMARCA2 oncology program and an undisclosed oncology target, as well as three discovery programs utilising Foghorn’s Gene Traffic Control® platform.