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news.The US Food and Drug Administration (FDA) has accepted Clovis Oncology's Investigational New Drug (IND) application to commence clinical investigation of CO-1686.
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CO-1686 is a novel, oral, targeted covalent inhibitor of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC).
Clovis, in partnership with Avila Therapeutics, designed and developed CO-1686 to selectively target both the initial activating EGFR mutations as well as the T790M mutation.
After achieving the appropriate dose, the company plans to study CO-1686 in an expansion cohort of NSCLC patients who have failed either Tarceva or Iressa.
The company said initial Phase I/II studies are likely to begin in the US and Europe during the second quarter of this year and in Asia during Q3, 2012.
Clovis Oncology president and CEO Patrick J Mahaffy said they are pleased to advance the CO-1686 development program into the clinic and look forward to initiating clinical studies in the US, Europe and Asia over the next several months.
Preclinical data demonstrated that CO-1686 causes tumor shrinkage in T790M-driven NSCLC xenograft models, and resulted in inhibitng tumor growth at a range of doses.
In collaboration with Roche Molecular Systems, Clovis is developing a companion diagnostic to diagnose patients with the T790M mutation.