Exelixis has submitted an IND application to the FDA for XL019. In preclinical studies, the compound has shown to be a potent, selective and orally available small molecule inhibitor of the cytoplasmic tyrosine kinase JAK2, according to the company. Activating mutations in JAK2 are frequently observed in patients with myeloproliferative disorders such as myelofibrosis, polycythemia vera and essential thrombocythemia. JAK2 activity is also upregulated via multiple mechanisms in many lymphomas and solid tumors.
"This is our fourth IND filing this year, reflecting the integration and productivity of our discovery and development processes," said Gisela M. Schwab, M.D., senior vice president and chief medical officer at Exelixis. "XL019 is a potent inhibitor of the JAK/STAT signaling pathway, which plays a critical role in cell growth and survival in a number of diseases where few clinical options currently exist. We believe that evaluation of XL019 in such indications may allow us to early on in clinical development observe biologic activity and potentially affect clinical outcome."
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