China CDE has approved Glubio's GLB-001, a CK1α degrader, for the Investigational New Drug (IND) application in patients with myeloid neoplasm (AML/MDS). Glubio Therapeutics submitted the IND application on December 9th, 2023. The FDA cleared the IND application for GLB-001 in April 2023, and the first-in-human trial ( NCT06146257 ) was initiated in January 2024, focusing on patients with relapsed or refractory acute myeloid leukemia (R/R AML) or higher-risk myelodysplastic syndromes (R/R HR-MDS). GLB-001 is a molecular glue targeting CK1α, different from their second degrader GLB-002, which is targeting Aiolos and Ikaros. Casein kinase 1 alpha ( CK1α ), encoded by gene CSNK1A1, is a ubiquitously expressed serine/threonine protein kinase in the CK1 kinase family. CK1α, as a key regulator of the Wnt/β-catenin pathway, directly phosphorylates β-catenin at Ser45 and thereby targets it for proteasomal degradation. CK1α was also known to regulate the protein stab...
China Biotech XYZ Shares Updates Related to New Drug Development in China