Exelixis Files Anti-Cancer IND

Exelixis has submitted an IND application to the FDA for XL147, a novel anticancer compound. XL147 is an orally available small molecule inhibitor of phosphoinositide-3 kinase (PI3K). Activation of PI3K is a frequent event in human tumors, promoting tumor cell growth, survival, and resistance to chemotherapy and radiotherapy.

“A growing body of data indicates that inappropriate activation of the PI3K signaling pathway is a common feature of human tumors and may result from dysregulation at multiple points along the signaling cascade,” said Gisela M. Schwab, MD, senior vice president and chief medical officer at Exelixis. “We are therefore evaluating multiple compounds that inhibit distinct components of the PI3K pathway. XL147 potently and selectively inhibits PI3K. In January, we filed an IND for XL418, which inhibits AKT and S6K, key components of the signaling cascade downstream of PI3K, and later this year we expect to file an IND for a third compound targeting both PI3K and mTOR. With this strategy, we believe that we are well positioned to maximize the potential of inhibiting the PI3K pathway for the treatment of multiple cancers.”

This is the twelfth IND that Exelixis has filed from its internal discovery and development programs. The company expects to file at least two additional INDs by the end of 2007.