Oncothyreon, Array BioPharma Restructure Agreement For ONT-380
By Cyndi Root
Oncothyreon and Array BioPharma have restructured their development agreement for ONT-380 (ARRY-380), an oral agent to treat metastatic breast cancer. The companies announced the deal in a press release, stating that the new agreement replaces the joint Development and Collaboration Agreement, and grants Oncothyreon the exclusive license to develop, manufacture and market ONT-380.
Robert L. Kirkman, M.D., President and CEO of Oncothyreon, said, "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.”
Oncothyreon and Array BioPharma Agreement
According to the previous agreement between Oncothyreon and Array BioPharma initiated May 30, 2013, the companies agreed to jointly develop the agent. Oncothyreon agreed to pay Array $10 million upfront, fund, and conduct the clinical development. The two companies were to conduct Phase 3 development jointly with an option to withdraw in exchange for royalties. Array and Oncothyreon agreed to co-promote in the U.S., jointly fund those activities, and jointly profit. Array agreed to market the agent worldwide and receive royalties.
The new agreement calls for Oncothyreon to pay Array $20 million upfront for the exclusive license. Oncothyreon has also agreed to pay Array if it sublicenses the ONT-380 rights. Array is also due royalties based on sales. If another company buys the agent within three years of the current agreement, Array is eligible for up to $280 million in payments.
ONT-380
ONT-380, formerly ARRY-380, is a small molecule HER2 inhibitor. Array showed in preclinical trials that the agent exhibited tumor growth inhibition and was well tolerated. Compared to Herceptin (trastuzumab) and Tykerb (lapatinib), tumor growth inhibition was superior. When dosed in combination with Herceptin or Taxotere (docetaxel), ONT-380 synergized or complemented their action.
In a Phase 1 trial of ONT-380 in 50 patients, ONT-380 showed a favorable safety profile and low prevalence of adverse events, including diarrhea, rash, and fatigue due to ONT-380’s selectivity for HER2. Oncothyreon is conducting a Phase 1b trial of ONT-380 in combination with Xeloda (capecitabine) and/or Herceptin (trastuzumab). Another Phase 1b trial is evaluating ONT-380 in combination with Kadcyla.