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news.Array BioPharma (ARRY) has granted an exclusive license to US-based biopharmaceutical firm Oncothyreon for the development, manufacturing and commercialization of ONT-380 (ARRY-380), an orally active, reversible and selective small molecule HER2 inhibitor.
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The license agreement replaces the prior development and collaboration agreement, under which the two firms were jointly developing ONT-380.
Under the license deal, Oncothyreon will pay Array $20m as an upfront fee as well a significant portion of any payments received from sublicensing ONT-380 rights.
If Oncothyreon is acquired within three years of the effective date of the current agreement, Array will be eligible to receive about $280m in commercial milestone payments.
Based on net sales of ONT-380, Array is also eligible to receive about double-digit royalty.
In multiple preclinical tumor models, Array-discovered ONT-380 was well tolerated and showed significant dose-related tumor growth inhibition that was superior to Herceptin (trastuzumab) and Tykerb (lapatinib).
In addition, ONT-380 also showed synergistic or additive tumor growth inhibition in these models, when dosed in combination with the standard-of-care therapeutics Herceptin or Taxotere (docetaxel).
A Phase I trial of ONT-380, with both dose-escalation and expansion components, has been completed in 50 patients, of whom 43 had HER2 positive metastatic breast cancer.
Currently, the company is conducting two Phase Ib trials of ONT-380 in combination with other agents.