U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation

“ABM-1310 is an orally administered medicine with high BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability. It is one of innovative drugs independently developed by ABM. ABM-1310 is in Phase I studies at multiple clinical sites in the U.S. and China for BRAF V600-mutant advanced solid tumors. The interim result from its U.S. Phase 1 study was presented in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating ABM-1310’s promising anticancer activity and good safety profile in patients with advanced BRAF V600 mutant solid tumors including primary brain tumors such as GBM and other gliomas. A new Phase I clinical trial specifically targeting GBM has recently been initiated in China.”