Oncothyreon Announces Exclusive License Agreement With Array BioPharma for ONT-380
December 12 2014 - 7:00AM
Oncothyreon Inc. (Nasdaq:ONTY) today announced that Array BioPharma
Inc. (Nasdaq:ARRY) has granted Oncothyreon an exclusive license to
develop, manufacture and commercialize ONT-380 (ARRY-380), an
orally active, reversible and selective small molecule HER2
inhibitor. The license agreement replaces the prior Development and
Collaboration Agreement under which Oncothyreon and Array were
jointly developing ONT-380.
As part of the agreement, Oncothyreon will pay Array $20 million
as an upfront fee. In addition, Oncothyreon will pay Array a
significant portion of any payments received from sublicensing
ONT-380 rights. If Oncothyreon is acquired within three years
of the effective date of the current agreement, Array will be
eligible for up to $280 million in commercial milestone payments.
Array is also entitled to receive up to a double-digit royalty
based on net sales of ONT-380.
"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," said
Robert L. Kirkman, M.D., President and Chief Executive Officer of
Oncothyreon. "We are pleased, therefore, to obtain the
exclusive rights to develop and commercialize ONT-380."
About ONT-380
ONT-380 is an orally active, reversible and selective HER2
inhibitor invented at Array. 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 Tykerb® and to the investigational drug,
neratinib, in an intracranial HER2 positive 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 positive metastatic breast cancer. All HER2 positive
breast cancer patients had progressed on a Herceptin-containing
regimen. In addition, over 80 percent 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. Twenty-two HER2
positive 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 percent.
Oncothyreon is currently conducting two Phase 1b trials of
ONT-380 in combination with other agents. The first trial
(ClinicalTrials.gov Identifier NCT02025192) is a parallel
dose-escalation study of ONT-380 in combination with Xeloda®
(capecitabine) and/or Herceptin® (trastuzumab) in patients who have
been previously treated with Herceptin and Kadcyla®
(ado-trastuzumab emtansine or TDM-1) for metastatic breast cancer.
The second trial (ClinicalTrials.gov Identifier NCT01983501)
is a dose-escalation study of ONT-380 in combination with Kadcyla
in patients who have been previously treated with Herceptin and a
taxane for metastatic breast cancer. Preliminary data from both
trials will be presented today at the San Antonio Breast Cancer
Symposium and are summarized in an accompanying press
release.
About Oncothyreon
Oncothyreon is a clinical-stage biopharmaceutical company
specializing in the development of innovative therapeutic products
for the treatment of cancer. Our goal is to discover, develop and
commercialize novel compounds that have the potential to improve
the lives and outcomes of cancer patients. Our current
clinical-stage product candidates include ONT-380, an orally active
and selective small molecule HER2 inhibitor, and ONT-10, a
therapeutic vaccine targeting MUC1. We are developing preclinical
product candidates in oncology, and potentially certain rare
diseases, using our recently acquired protocell
technology. For more information, visit
www.oncothyreon.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.
Additional Information
Additional information relating to Oncothyreon can be found on
EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
CONTACT: Oncothyreon Investor and Media Relations Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@oncothyreon.com
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