SEATTLE, WA and
BOULDER, CO, Feb. 20, 2014 /PRNewswire/ - Oncothyreon Inc.
(NASDAQ: ONTY) and Array BioPharma Inc. (NASDAQ: ARRY) today
announced the initiation of a Phase 1b trial of ONT-380 (ARRY-380)
in combination with Kadcyla® (ado-trastuzumab emtansine or TDM-1)
in patients with metastatic HER2+ breast cancer. ONT-380 is
an orally active, reversible and selective small-molecule HER2
inhibitor invented by Array and being developed by Oncothyreon in
collaboration with Array.
The trial (ClinicalTrials.gov Identifier
NCT01983501) is a dose-escalation study in up to 48 patients who
have been previously treated with Herceptin® (trastuzumab) and a
taxane for metastatic breast cancer. The primary objective is
to determine the maximum-tolerated and/or recommended Phase 2 dose
(MTD/RP2D) of ONT-380 in combination with the approved dose of
Kadcyla. Secondary objectives include an evaluation of the
safety and preliminary anti-tumor activity of the
combination. Following determination of the MTD/RP2D, the
study includes an expansion arm at the MTD/RP2D as well as an
optional second expansion arm in patients with central nervous
system metastases.
"ONT-380 and Kadcyla are both directed at HER2,
but with differing mechanisms of action," said Diana Hausman, M.D., Chief Medical Officer of
Oncothyreon. "The strategy of combining two agents targeting HER2
has previously proven useful in HER2+ breast cancer, and we believe
the combination of ONT-380 and Kadcyla is particularly relevant to
evaluate as the treatment of metastatic HER2+ breast cancer
continues to evolve."
About ONT-380
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
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 Tykerb®
and to the investigational drug, neratinib, in an intracranial
HER2+ breast cancer xenograft model.
A Phase 1 trial of ONT-380, with both
dose-escalation and expansion components, has been completed in 50
patients, 43 of whom had HER2+ metastatic breast cancer. All HER2+
breast cancer patients had progressed on a Herceptin-containing
regimen. In addition, over 80% had been treated with Tykerb, with
many having progressed on therapy. 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.
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 (BID). Twenty-two 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
Tykerb- and Herceptin-containing regimens.
In addition to the Phase 1b trial of ONT-380 in
combination with Kadcyla described above, Oncothyreon recently
initiated a second Phase 1b trial of ONT-380 in combination with
Herceptin and/or Xeloda® (capecitabine) in patients with metastatic
HER2+ breast cancer. The Dana-Farber Cancer Institute,
Boston, Massachusetts, is also
currently conducting an investigator-sponsored trial of ONT-380 in
combination with Herceptin in patients with brain metastases from
HER2+ breast cancer.
About Oncothyreon
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.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical
company focused on the discovery, development and commercialization
of targeted small molecule drugs to treat patients afflicted with
cancer. Seven Phase 3 or pivotal studies are already in
progress, or are planned to begin, within the next year. These
programs include the wholly-owned hematology drug, filanesib
(ARRY-520), for multiple myeloma and two partnered cancer drugs,
selumetinib (AstraZeneca) and MEK162 (Novartis). For more
information on Array, please go to www.arraybiopharma.com
Oncothyreon Forward-Looking
Statements
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 activities.
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 hereof.
Array BioPharma Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements about the potential for
the results of ongoing clinical trials to support further
development, regulatory approval or the marketing success of
ONT-380 (ARRY-380), anticipated clinical and other product
development activities related to ONT-380 (ARRY-380) and the costs
and responsibilities of those activities, expected benefits and
market potential for ONT-380 (ARRY-380), and the success of
activities to obtain market approval and sales. These statements
involve significant risks and uncertainties, including those
discussed in the most recent annual report filed on Form 10-K,
quarterly reports filed on Form 10-Q, and other reports filed by
Array with the Securities and Exchange Commission. Because these
statements reflect current expectations concerning future events,
actual results could differ materially from those anticipated in
these forward-looking statements as a result of many factors. These
factors include, but are not limited to, the ability of Array and
Oncothyreon to continue to fund and successfully progress research
and development efforts with respect to ONT-380 (ARRY-380); risks
associated with dependence on collaborators for the clinical
development and commercialization of out-licensed drug candidates,
including ONT-380 (ARRY-380); the ability to effectively and timely
conduct clinical trials in light of increasing costs and
difficulties in locating appropriate trial sites and in enrolling
patients who meet the criteria for certain clinical trials; and
risks associated with dependence on third-party service providers
to successfully conduct clinical trials within and outside
the United States. Array is
providing this information as of February
20, 2014 and undertakes no duty to update any
forward-looking statements to reflect the occurrence of events or
circumstances after the date of such statements or of anticipated
or unanticipated events that alter any assumptions underlying such
statements.
Additional Information
Additional information relating to Oncothyreon can be found on
EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
SOURCE Oncothyreon Inc.