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Exelixis is planning pivotal trials and partnerships for this year, with several discussions underway, CEO George Scangos told Pharmawire. “We have a huge year coming up in terms of events,” pointing to the listed, California biotech company’s upcoming pipeline advances.
The company recently out-licensed its XL880 cancer compound to GlaxoSmithKline (GSK) - and received USD 35m from for the license. Exelixis stands to earn additional milestone payments from GSK upon later stage development.
High priorities this year are three products moving into pivotal trials this summer: XL647 in non-small-cell lung cancer, XL184 in medullary thyroid cancer and XL019 in myelofibrosis.
More Phase I and II data on all three compounds are expected to be released at the American Society of Clinical Oncology (ASCO) meeting in June.
XL647, which inhibits multiple targets known as VEGFR2, EGFR and HER2, is a licensing candidate this year, as is XL019, which blocks a receptor known as JAK2.
Exelixis is “quite confident” that it will sign more deals this year, as several such discussions are already ongoing. There is partnership interest on XL647 and XL019, Scangos said, as well as on a pair of PI3 kinase inhibitors, XL147 and XL765.
The latter two, he added, “should enhance the activity of many existing cancer drugs,” both chemotherapies and targeted agents.
The company is also anticipating opt-in decisions on additional compounds from California-based Genentech and New York-based Bristol-Myers Squibb.
Also this year, GSK has an option to license XL184, a PI3 kinase inhibitor that Scangos said continues to stop progression in thyroid cancer patients in a trial that is still enrolling, per terms of its broad alliance with Exelixis.
GSK is expected to review data around mid-year to determine whether to bring it on board or not. The relationship covers seven compounds as well as back-up and follow-up compounds currently in the Exelixis development pipeline.
Exelixis submits them to GSK as they achieve clinical proof-of-concept, and after licensing XL880, the UK-based pharmaceutical firm can opt for one more Exelixis compound, and potentially a third, for further clinical development and commercialization. The arrangement includes milestone payments, double-digit royalties and co-promotion rights for Exelixis.
XL880 is a small-molecule MET inhibitor in Phase II for papillary renal cell carcinoma, gastric cancer and head and neck cancer. Scangos said more renal and gastric cancer data are expected at ASCO.
Scangos underscored the “unique” nature of the royalty payments potentially due Exelixis from GSK, which begin in the double digits and can reach “quite substantial” amounts.
Should these agreements move forward, the would-be partners would take over all future development costs, and Scangos said more of these arrangements on “compounds to be delivered later” could be signed this year.
The company’s research and development budget for this year has yet to be determined. But Exelixis had more than USD 290m in cash reserves at the start of the year.
Its market cap is about USD 856m.
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