December 12, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Clinical-stage biopharmaceutical Oncothyreon announced today that it will partner with Array BioPharma on the development, manufacture and commercialization of breast cancer drug ONT-380 for $20 million in upfront payments, with an additional $280 milestone payments available to Array if Oncothyreon is acquired within three years.
The license agreement replaces the prior Development and Collaboration Agreement under which Oncothyreon and Array were jointly developing ONT-380. The company specializes in the development of products and therapies for the treatment of cancer.
ONT-380 is an orally active, reversible and selective small molecule HER2 inhibitor. So far, the drug has done well in preclinical tumor models, with demonstrated dose-related tumor growth inhibition that was superior to competitors Herceptin (trastuzumab) and Tykerb (lapatinib).
Clinicians are also watching ONT-380 because it has demonstrated synergistic or additive tumor growth inhibition when dosed in combination with the usually used therapeutics Herceptin or Taxotere (docetaxel). ONT-380 has shown encouraging results when combined with investigational drug, neratinib, in an intracranial HER2 positive breast cancer xenograft model.
“We are encouraged by the positive preliminary evidence of efficacy and tolerability seen in patients with advanced metastatic breast cancer in our ongoing Phase 1b trials of ONT-380, as will be reported today at the San Antonio Breast Cancer Symposium,” said Robert Kirkman, president and chief executive officer of Oncothyreon. “We are pleased, therefore, to obtain the exclusive rights to develop and commercialize ONT-380.”
Oncothyreon is currently running two Phase 1b trials of ONT-380 in combination with as a combo with other drugs; the first trial is a parallel dose-escalation study of ONT-380 in combination with Xeloda (capecitabine) and/or Herceptin (trastuzumab) in patients who have been previously treated with Herceptin and Kadcyla (ado-trastuzumab emtansine or TDM-1) for metastatic breast cancer.
The second trial gives patients escalating doses of ONT-380 in combination with Kadcyla in patients who have been previously treated with Herceptin and a taxane for metastatic breast cancer. The company said the preliminary data for both trials will be presented at the San Antonio Breast Cancer Symposium Friday.
