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Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts.

M2 PHARMA-February 14, 2019-Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts


- US-based biotechnology company Exelixis, Inc. (NASDAQ: EXEL) 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, the company said.

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 application Exelixis submitted to the US Food and Drug Administration in December 2018.

This 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.

Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialisation of new medicines for difficult-to-treat cancers.

Its discovery efforts have resulted in four approved products, Cabometyx (cabozantinib), Cometriq (cabozantinib), Cotellic (cobimetinib) and Minnebro (esaxerenone), and it has entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide.

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Publication:M2 Pharma
Date:Feb 14, 2019
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