) recently started a phase I investigator sponsored study on its
candidate, ONT-380 (also known as ARRY-380). In the study,
) Herceptin will be evaluated for patients with brain metastases
due to HER2+ breast cancer. Dana-Farber Cancer Institute, based
in Boston, MA will sponsor the study.
The dose-escalation study will evaluate about 50 patients. The
primary objective of the study is to ascertain the maximum
tolerated dose and a suitable phase II dose of ONT-380 combined
with Herceptin in patients with HER2+ breast cancer and central
nervous system (CNS) metastases. CNS objective response rate,
progression-free survival and overall survival are the secondary
endpoints of the study.
The study will be carried out with two distinct doses, either
once-daily or twice-daily, combined with the standard dosage of
In May 2013, Oncothyreon entered into a collaboration agreement
Array BioPharma, Inc.
) to develop and commercialize the candidate.
Array is expected to receive an upfront fee of $10 million on the
initiation of the collaboration. As per the terms of the
agreement, Oncothyreon will be responsible for the development of
ONT-380 in multiple proof-of-concept studies in patients
suffering from metastatic breast cancer, including patients
having brain metastases. These studies will evaluate the
candidate in combination with other approved breast cancer drugs.
Following the completion of the agreement, Array and Oncothyreon
plan to jointly conduct a phase III program on the candidate,
supported by the 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 US. The companies
will be, however, sharing the commercialization costs and profit
equally in the US. Oncothyreon is entitled to receive
double-digit royalty on net sales in ex-U.S. markets. Moreover,
the companies will share evenly any proceeds from sublicense of
the marketing rights.
Oncothyreon carries a Zacks Rank #3 (Hold). Currently, companies
which look attractive include
Gilead Sciences Inc.
) with a Zacks Rank #1 (Strong Buy).
ONCOTHYREON INC (ONTY): Free Stock Analysis
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