China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase III clinical study for its Category 1 chemical drug XY0206, which targets recurrent/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal tandem duplication).
XY0206: A Promising Multi-Target Tyrosine Kinase Inhibitor
XY0206 is a 2-Indoleketone multi-target tyrosine kinase inhibitor that aims to outperform sunitinib, an earlier-generation compound. XY0206 shares a similar enzyme inhibition profile with sunitinib, capable of inhibiting FLT3, c-Kit, and PDGFR β, as well as receptor tyrosine kinases (RTKs) such as RET and VEGFR2. Notably, XY0206 exhibits stronger inhibitory activity against FLT3 and dual inhibitory activity against FLT3-ITD and FLT3-TKD, potentially overcoming the resistance of type II tyrosine kinase inhibitors. Yiling Pharmaceutical describes XY0206 as more selective and with a broader safe treatment window, attributed to its improved metabolic stability and lack of tissue accumulation, positioning it as a next-generation RTK inhibitor.
Phase I Study Conclusion and Upcoming Clinical Trials
XY0206 has previously completed a Phase I study in China, which assessed the drug’s safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced/metastatic malignant solid tumors and relapsed/refractory AML. Additionally, two clinical studies were conducted to investigate the drug candidate’s interaction with itraconazole and the effect of dieting on its efficacy. The successful completion of these studies lays the groundwork for the upcoming Phase III clinical trial, which will further evaluate XY0206’s potential as a treatment for AML patients with FLT3-ITD mutation.-Fineline Info & Tech
