Oncothyreon Inc (ONTY) presented final data from the first phase I study (n=50) on ONT-380 (also known as ARRY-380). The final results from this study were presented at the American Association for Cancer Research Special Conference on Advances in Breast Cancer Research. ONT-380 is an orally active, reversible and selective small-molecule HER2 (human epidermal growth factor receptor 2) inhibitor.
43 out of the 50 patients were suffering from HER2+ metastatic breast cancer. The safety profile of ONT-380 was found to be acceptable level with treatment-related adverse events being primarily restricted to Grade 1. Only one patient was observed to have suffered treatment-related diarrhea of Grade 2 level and one patient experienced Grade 3 rash.
Additionally, no Grade 4 or cardiac events related to the treatment were observed. A dosage of 600 mg twice daily was ascertained as the maximum tolerated dose in this study. A clinical benefit rate of 27% was observed in 22 HER2+ breast cancer patients treated with ONT-380 (dosage >= 600 mg twice daily).
We note that Oncothyreon has been working hard for developing ONT-380. We also note that Oncothyreon has a collaboration agreement with Array BioPharma, Inc. (ARRY) to develop and commercialize ONT-380.
As per the agreement, Oncothyreon will be responsible for the development of ONT-380 in patients suffering from metastatic breast cancer, including patients with brain metastases.
Array and Oncothyreon plan to jointly conduct a phase III program on the candidate, supported by proof-of-concept studies. Both Array and Oncothyreon will have the right to stop further development and commercialization in lieu of royalty payments.
While Array will be responsible for the worldwide commercialization of the candidate, Oncothyreon will enjoy co-promotion rights to the candidate in the U.S. However, the companies will share the commercialization costs and profit equally in the U.S. Oncothyreon is entitled to receive double-digit royalty on net sales in ex-U.S. markets. Moreover, the companies will share any proceeds from sublicense of the marketing rights evenly.
Oncothyreon carries a Zacks Rank #4 (Sell). Currently, companies which look attractive include Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy) and Cempra, Inc. (CEMP) with a Zacks Rank #2 (Buy).