DAY101 PROGRAM

Advancing Day One’s lead investigational therapy

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DAY101 is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor.

Dysregulation of the MAPK pathway has been shown to occur in many cancer types and it is one of the most commonly mutated oncogenic pathways in cancer.

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.

Additional studies are planned with DAY101 alone or in combination with other agents that target key signaling nodes in the MAPK pathway, such as our MEK inhibitor pimasertib, in patient populations where RAS and RAF alterations are believed to play an important role in driving disease.

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.

Learn more about Day One’s ongoing
clinical trial programs.

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