– Phase 1 dose-escalation trial follows filing of IND in December 2018 –
ALAMEDA, CA, USA I February 12, 2019 I Exelixis, Inc. (Nasdaq: EXEL) today announced 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. 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.
“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”
“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.”
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four approved products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO™ (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
SOURCE: Exelixis
Post Views: 42
– Phase 1 dose-escalation trial follows filing of IND in December 2018 –
ALAMEDA, CA, USA I February 12, 2019 I Exelixis, Inc. (Nasdaq: EXEL) today announced 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. 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.
“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”
“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.”
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four approved products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO™ (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
SOURCE: Exelixis
Post Views: 42
