US biotech company Avila Therapeutics announced that it has achieved a significant goal in its $209 million alliance with Clovis Oncology (The Pharma Letter May 26, 2010). Together, the partners have selected a drug candidate to advance into clinical development from their epidermal growth factor receptor (EGFR) mutant‐selective inhibitor (EMSI) alliance.
The selected drug candidate, CO‐1686 (AVL‐301), has demonstrated encouraging tumor regression activity in animal models carrying both the activating mutation of EGFR and the T790M (“gatekeeper”) mutation that is resistant to approved drug therapies. CO‐1686 demonstrates no significant inhibition of normal (“wildtype”) EGFR, which is a source of dose‐limiting toxicities for current EGFR‐targeted therapies. Clovis is now advancing the drug candidate in preclinical development for the treatment of non‐small cell lung cancer (NSCLC). Developing in parallel with a corresponding companion diagnostic with Roche Molecular Diagnostics, Clovis plans to file an Investigational New Drug application for CO‐1686 in the first half of 2012.
“We have made excellent progress in advancing this EGFR Mutant‐Selective Inhibitor program, further validating the robustness of Avila’s platform and our ability to design targeted covalent drugs,” said Katrine Bosley, chief executive of Avila, adding: “This partnered program with Clovis, along with Avila’s proprietary clinical program targeting Bruton’s Tyrosine Kinase (Btk), show our advancement of drug candidates and exemplify the range of important problems that can be solved with targeted covalent drugs.”
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