PHI-501

PHI-501 is a novel, small molecule dual kinase inhibitor targeting pan-RAF and discoidin domain receptors (DDR1 and DDR2). Developed by Pharos iBio, it is specifically designed to treat refractory solid tumors and hematologic malignancies, including acute myeloid leukemia (AML), lung cancer, and melanoma. The drug's mechanism involves the simultaneous inhibition of the MAPK and PI3K signaling pathways, which allows it to demonstrate potent anti-proliferative activity against cancer cells harboring KRAS (e.g., G12V, G12S, Q61H) and NRAS mutations. PHI-501 has shown potential in overcoming resistance to KRAS G12C inhibitors and has received Orphan Drug Designation from the U.S. FDA for AML. It is currently in Phase 1 clinical development following approval from South Korea's Ministry of Food and Drug Safety in June 2025.