FDA granted Orphan Drug Designation to TP-1287 for the treatment of patients with Ewing Sarcoma

It is an oral phosphate prodrug of alvocidib, a CDK9 inhibitor which is currently undergoing Phase 1 evaluation in the US for advanced metastatic or progressive solid tumors

Previously FDA also granted TP-1287 a Rare Pediatric Disease Designation for the treatment of Ewing sarcoma

“TP-1287 exhibits potent inhibition of intracellular kinases including CDK9. Inhibition of CDK9 leads to downregulation of key antiapoptotic proteins such as MCL-1, which in turn has been shown to inhibit tumor growth in preclinical models of hematologic malignancies and several tumor types.” said Jatin J. Shah, M.D., Sumitomo Pharma’s Chief Medical Officer