On February 12, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported it is initiating phase 1 clinical development for XL092, the first internally-discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug discovery activities (Press release, Exelixis, FEB 12, 2019, View Source [SID1234533261]). XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, and other kinases implicated in cancer’s growth and spread. The molecule is the subject of an active Investigational New Drug (IND) application Exelixis submitted to the U.S. Food and Drug Administration in December 2018.
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"Exelixis is building a pipeline of diverse investigational medicines behind cabozantinib through in-house drug discovery activities and targeted in-licensing," said Peter Lamb, Ph.D., Executive Vice President of Scientific Strategy and Chief Scientific Officer of Exelixis. "XL092 is a novel compound that targets key signal transduction pathways in tumors, while potentially addressing tumor-induced immune suppression. Data from the upcoming phase 1 clinical trial will be used to determine the potential for further development of XL092."
The multi-center phase 1 clinical trial is designed to evaluate the pharmacokinetics, safety and tolerability of XL092. The trial is divided into dose-escalation and expansion phases. The dose-escalation phase of the trial will enroll patients with advanced solid tumors, with the primary objective of determining a dose for daily oral administration of XL092 suitable for further evaluation. Assuming positive data from the initial phase of the trial, the expansion phase is designed to further explore the selected dose of XL092 in individual tumor cohorts, where safety, tolerability, and initial clinical activity would be evaluated.
"Supported by revenues from the global cabozantinib franchise, Exelixis is building on our prolific drug discovery history to advance a new generation of Exelixis medicines," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "As the first molecule to enter clinical development from our new laboratories here in Alameda, XL092 represents an important milestone for our company and highlights our commitment to the patients we serve. We look forward to the clinical progress of XL092 and the continued maturation of other earlier-stage molecules currently in development."