Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration ("FDA") has granted orphan drug designation to
tucatinib for the treatment of HER2-positive (HER2+) metastatic
colorectal cancer. Tucatinib is an investigational oral, small
molecule kinase inhibitor that is highly selective for HER2 and is
the Company’s lead product in development.
The FDA’s Orphan Drug Designation program provides orphan status
to drugs defined as those intended for the safe and effective
treatment, diagnosis or prevention of rare diseases that affect
fewer than 200,000 people in the United States. Orphan designation
qualifies the sponsor of the drug for certain development
incentives, including tax credits for qualified clinical testing,
prescription drug user fee exemption and 7-year marketing
exclusivity upon FDA approval.
“We are pleased to receive FDA orphan drug designation for
tucatinib in HER2+ metastatic colorectal cancer, our second orphan
designation in addition to breast cancer with brain metastases,”
said Scott Myers, President and CEO of Cascadian Therapeutics. “We
believe tucatinib has the potential to address unmet medical needs
of patients in a broad range of HER2-positive cancers. We are
currently supporting an investigator-initiated study evaluating
tucatinib for the treatment of patients with HER2+ metastatic
colorectal cancer.”
“We are conducting a Phase 2 study called MOUNTAINEER evaluating
tucatinib in combination with trastuzumab for patients with HER2
amplified metastatic colorectal cancer,” said John Strickler, MD,
Assistant Professor of Medicine, Division of Medical Oncology, Duke
University Medical Center, and principal investigator of the
MOUNTAINEER study. “There remains an unmet clinical need for new
treatments for patients with HER2 amplified metastatic colorectal
cancer. Tucatinib is a potent and selective inhibitor of HER2 in
vitro, and is active in non-clinical HER2+ colorectal tumor
models. Based on these data, we believe tucatinib has the
potential to be a new therapeutic option for these patients.”
The study, known as MOUNTAINEER, is currently recruiting
participants. Additional details about MOUNTAINEER can be found at
www.clinicaltrials.gov (NCT03043313).
The American Cancer Society estimates 135,430 new cases of
colorectal cancer will be diagnosed in the U.S. in 2017, and
expects colorectal cancer to cause over 50,000 deaths in 2017.
Colorectal cancer is the third leading cause of cancer death in
both men and women in the U.S. While the prevalence of HER2
amplified colorectal cancer varies depending on study methods and
population, approximately 3-to-8 percent of these patients would be
expected to potentially benefit from HER2-targeted therapy.1
About Tucatinib
Tucatinib is an investigational, orally bioavailable, potent
tyrosine kinase inhibitor that is highly selective for HER2 without
inhibition of EGFR. Inhibition of EGFR has been associated with
clinical toxicities, including skin rash and diarrhea. Tucatinib
has shown activity as a single agent and in combination with both
chemotherapy and other HER2 directed agents such as trastuzumab.2,3
Studies of tucatinib in these combinations have shown activity both
systemically and in brain metastases. HER2 is a growth factor
receptor that is overexpressed in multiple cancers, including
breast, ovarian and gastric cancers. HER2 mediates cell growth,
differentiation and survival. Tumors that overexpress HER2 (HER2+)
are more aggressive and historically have been associated with poor
overall survival, compared with HER2-negative cancers.
About Cascadian Therapeutics Cascadian
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to developing innovative product candidates for the
treatment of cancer. Its lead product candidate, tucatinib, is an
investigational oral, selective small molecule HER2 inhibitor.
Cascadian Therapeutics is conducting a randomized, double-blind,
controlled pivotal clinical trial called HER2CLIMB, which is
comparing tucatinib vs. placebo, each in combination with
capecitabine and trastuzumab, in patients with locally advanced or
metastatic HER2+ breast cancer with and without brain metastases,
who have previously been treated with trastuzumab, pertuzumab and
T-DM1. Additional details on HER2CLIMB can be found at
www.HER2CLIMB.com or www.clinicaltrials.gov. For more information,
please visit www.cascadianrx.com. Forward-Looking
Statements In order to provide Cascadian Therapeutics'
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, but the absence of these words does not
necessarily mean that a statement is not forward-looking.
Forward-looking statements include, without limitation, statements
regarding clinical development activities, timing of additional
data, the potential benefits of its product candidates, timing of
regulatory filings, and potential regulatory approvals of its
product candidates. Any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements. Forward-looking
statements involve risks and uncertainties related to Cascadian
Therapeutics' business and the general economic environment, many
of which are beyond its control. These risks, uncertainties and
other factors could cause Cascadian Therapeutics' actual results
and timing of events to differ materially from those anticipated in
forward-looking statements, including, without limitation, the
risks associated with the costs and expenses of developing its
product candidates, the adequacy of financing and cash, cash
equivalents and investments, changes in general accounting
policies, general economic factors, achievement of the results it
anticipates from its preclinical development and clinical trials of
its product candidates, the receipt of regulatory approvals, its
ability to adequately obtain and protect its intellectual property
rights, and other factors discussed under the caption "Risk
Factors" in Cascadian Therapeutics’ Quarterly Report on Form 10-Q
for the quarterly period ended June 30, 2017 filed with the
Securities and Exchange Commission. Although Cascadian Therapeutics
believes that the forward-looking statements contained herein are
reasonable as of the date hereof, 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 Cascadian Therapeutics' risks and
uncertainties, you should review the documents filed by Cascadian
Therapeutics with the securities regulators in the United States on
EDGAR and in Canada on SEDAR. Cascadian Therapeutics disclaims any
obligation to publicly update or revise its forward-looking
statements based on events or circumstances after the date hereof,
except to the extent required by law.
1 Takegawa N and Yonesaka K. HER2 emerging oncotarget for
colorectal cancer treatment after failure of anti-epidermal growth
factor receptor therapy. Clin Colorectal Cancer 2017 Mar 9.
Pii:S1533-0028(16)30240-7.2 Moulder, S. et al., Phase 1 Study
of ONT-380, a HER2 Inhibitor, in Patients with HER2+ Advanced Solid
Tumors, with an Expansion Cohort in HER2+ Metastatic Breast
Cancer. Clin Cancer Res. May 2017. 3 Hamilton, E. et
al., Efficacy of a Phase 1b Study of Tucatinib (ONT-380), an
Oral HER2-Specific Inhibitor, in Combination with Capecitabine and
Trastuzumab in HER2+ Metastatic Breast Cancer, Including Patients
with Brain Metastases. Presented at the San Antonio Breast Cancer
Symposium (SABCS) Annual Meeting 2016, San Antonio, TX. December 9,
2016 (Poster P4-21-01).
Source: Cascadian Therapeutics, Inc.
Investor and Media
Contact:Monique GreerCascadian
Therapeutics206-801-2107mgreer@cascadianrx.com
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