Advancing Day One’s lead investigational therapy
DAY101 is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor.
DAY101 is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which may offer an important alternative for people with primary brain tumors or brain metastases of solid tumors.
DAY101 has been studied in over 300 patients to date. Currently DAY101 is under evaluation in a pivotal Phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric low-grade glioma (pLGG). pLGG is the most common form of childhood brain cancer with no approved therapies today. We have also initiated a Phase 1/2 study (FIRELIGHT-1) with DAY101 in patients with recurrent or progressive solid tumors with activating RAF alterations.
DAY101 has the potential to become an important alternative for people with primary brain tumors or brain metastases of solid tumors.
DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. DAY101 has also received Orphan Drug designation from both the FDA and the European Medicines Agency (EMA) for the treatment of malignant glioma.