Oncothyreon Announces Presentation of Final Results from Phase 1 Trial of
SEATTLE, WA, Oct. 7, 2013
SEATTLE, WA, Oct. 7, 2013 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today
announced the presentation of final results from the first Phase 1 trial of
ONT-380 at the American Association for Cancer Research Special Conference on
Advances in Breast Cancer Research in San Diego. The results were presented
by Virginia F. Borges, M.D., Associate Professor in the Division of Medical
Oncology, University of Colorado School of Medicine. ONT-380 (also known as
ARRY-380) is an orally active, reversible and selective small-molecule HER2
inhibitor being developed by Oncothyreon in collaboration with Array BioPharma
Inc. (Nasdaq: ARRY), Boulder, Colorado.
The first-in-human Phase 1 trial, with both dose-escalation and expansion
components, enrolled a total of 50 patients, 43 of whom had HER2+ metastatic
breast cancer. In this study, ONT-380 demonstrated an acceptable safety
profile; treatment-related adverse events were primarily Grade 1. Because
ONT-380 is selective for HER2 and does not inhibit EGFR, there was a low
incidence and severity of treatment-related diarrhea, rash and fatigue, side
effects which have been associated with EGFR inhibition. A single patient
experienced Grade 2 treatment-related diarrhea and no patient developed
treatment-related Grade 3 diarrhea; one patient had a Grade 3 rash.
Additionally, there were no treatment-related cardiac events or Grade 4
treatment-related adverse events reported. The maximum tolerated dose of
ONT-380 established in this Phase 1 trial was 600 mg twice daily. The
dose-limiting toxicity was reversible elevation in liver enzymes.
In this trial, 22 HER2+ breast cancer patients with measurable disease were
treated with ONT-380 at doses greater than or equal to 600 mg BID. In this
heavily pretreated patient population, there was a clinical benefit rate
(partial response [n = 3] plus stable disease for at least 6 months [n = 3])
of 27%. Notably, two of the patients with partial responses during treatment
with ONT-380 had confirmed progressions while on prior lapatinib- and
"We believe that ONT-380's selectivity for HER2, without also targeting EGFR,
positions ONT-380 as a potential best-in-class small molecule HER2 inhibitor,"
said Robert L. Kirkman, M.D., President and Chief Executive Officer of
Oncothyreon. "Results from this first-in-human trial provide preliminary
evidence of activity against HER2+ breast cancer with a low incidence of
EGFR-related side effects. We are looking forward to the initiation of
Oncothyreon's planned Phase 1b trials of ONT-380, which we currently expect to
begin before year end."
ONT-380 is an orally active, reversible and selective HER2 inhibitor. In
multiple preclinical tumor models, ONT-380 was well tolerated and demonstrated
significant dose-related tumor growth inhibition that was superior to
Herceptin® (trastuzumab) and Tykerb® (lapatinib). Additionally, in these
models, ONT-380 demonstrated synergistic or additive tumor growth inhibition
when dosed in combination with the standard-of-care therapeutics Herceptin or
Taxotere® (docetaxel). ONT-380 has also demonstrated superior activity, based
on overall survival, compared to lapatinib and to the investigational drug,
neratinib, in an intracranial HER2+ breast cancer xenograft model.
Under the collaboration agreement with Array, Oncothyreon will conduct the
clinical development of ONT-380 through a defined set of combination
proof-of-concept trials in patients with metastatic breast cancer, including
patients with brain metastases. Oncothyreon currently expects to initiate its
clinical development of ONT-380 in the fourth quarter of 2013. In addition,
an investigator-sponsored trial of ONT-380 in combination with trastuzumab in
patients with brain metastases from HER2+ breast cancer is underway. The
trial is being conducted under the sponsorship of the Dana-Farber Cancer
Institute, Boston, Massachusetts.
Oncothyreon is a biotechnology company specializing in the development of
innovative therapeutic products for the treatment of cancer. Oncothyreon's
goal is to develop and commercialize novel synthetic vaccines and targeted
small molecules that have the potential to improve the lives and outcomes of
cancer patients. For more information, visit www.oncothyreon.com.
In order to provide Oncothyreon's investors with an understanding of its
current results and future prospects, this release contains statements that
are forward-looking. Any statements contained in this press release that are
not statements of historical fact may be deemed to be forward-looking
statements. Words such as "believes," "anticipates," "plans," "expects,"
"will," "intends," "potential," "possible" and similar expressions are
intended to identify forward-looking statements. These forward-looking
statements include Oncothyreon's expectations regarding clinical development
Forward-looking statements involve risks and uncertainties related to
Oncothyreon's business and the general economic environment, many of which are
beyond its control. These risks, uncertainties and other factors could cause
Oncothyreon's actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing, duration
and results of clinical trials, the timing and results of regulatory reviews,
the safety and efficacy of our product candidates, and the indications for
which our product candidates might be developed. There can be no guarantee
that the results of preclinical studies or clinical trials will be predictive
of either safety or efficacy in future clinical trials. Although Oncothyreon
believes that the forward-looking statements contained herein are reasonable,
it can give no assurance that its expectations are correct. All
forward-looking statements are expressly qualified in their entirety by this
cautionary statement. For a detailed description of Oncothyreon's risks and
uncertainties, you are encouraged to review the documents filed with the
securities regulators in the United States on EDGAR and in Canada on SEDAR.
Oncothyreon does not undertake any obligation to publicly update its
forward-looking statements based on events or circumstances after the date
Additional information relating to Oncothyreon can be found on EDGAR at
www.sec.gov and on SEDAR at www.sedar.com.
SOURCE Oncothyreon Inc.
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