Cascadian Therapeutics Announces 2018 Outlook and Recent Progress
04 Enero 2018 - 7:30AM
Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced an overview of recent
progress for tucatinib, an investigational oral, small molecule
kinase inhibitor that is highly selective for HER2 and the
Company’s lead product in development for the treatment of HER2
overexpressing cancers, in addition to several anticipated key
objectives for 2018.
“2017 was a very productive year across all aspects of our
business, and we delivered on our key objectives we set at the
beginning of the year,” said Scott D. Myers, President and Chief
Executive Officer of Cascadian Therapeutics. “Our pivotal
registrational trial of tucatinib for patients with HER2-positive
metastatic breast cancer with or without brain metastases remains
on track and enrolling patients in North America, Western Europe
and Australia. In 2018, we plan to update the market on HER2CLIMB
enrollment status after carefully assessing our European site
performance. We also look forward to the interim results from a
Phase 2 study of tucatinib in HER2 amplified metastatic colorectal
cancer, known as MOUNTAINEER, where there is an increasing need for
effective and well-tolerated treatment options.”
Recent Progress Update
The following accomplishments occurred during the fourth quarter
of 2017:
Tucatinib Development
- In December 2017, the Company reported results from a subgroup
analysis from its two ongoing combination studies of tucatinib,
which demonstrated prolonged progression-free survival benefit
regardless of presence of brain metastases or patient
characteristics. These results were presented at the 2017 San
Antonio Breast Cancer Symposium (SABCS).
- In December 2017, the first patient was enrolled in the
investigator-initiated Phase 1b/2 trial known as TULiP that is
evaluating tucatinib in combination with an aromatase inhibitor and
CDK4/6 agent for patients with hormone receptor-positive and
HER2-positive (HR+/HER2+) metastatic breast cancer. Based on the
activity of tucatinib in combination with multiple agents in
patients with brain metastases observed in prior studies, the trial
will also include these patients.
- As of December 2017, the investigator-initiated open label
Phase 2 study of tucatinib in combination with trastuzumab for
patients with HER2+/RAS wild type metastatic colorectal cancer,
known as MOUNTAINEER, was enrolling ahead of the lead
investigator’s anticipated timeline.
- As of December 2017, the Company has successfully manufactured
sufficient supply of tucatinib to complete all currently ongoing
trials, including HER2CLIMB.
Regulatory
- In December 2017, the European Medicines Agency (EMA) granted a
full product-specific waiver for the Pediatric Investigation Plan
(PIP), which means the Company is exempt from any requirements to
perform pediatric development of tucatinib for the treatment of
HER2+ metastatic breast cancer.
- In December 2017, EMA’s Scientific Advice Working Group
provided guidance on the planned manufacturing program for
tucatinib, to ensure that Cascadian’s manufacturing plans will be
acceptable for filing and commercial release in the EU.
- In November 2017, Health Canada validated the potential for the
ongoing HER2CLIMB pivotal clinical trial and nonclinical programs
to be sufficient for tucatinib registration, if data are
supportive.
Corporate
- In December 2017, Cascadian Therapeutics was officially added
to the Nasdaq Biotechnology Index.
- As of September 30, 2017, cash, cash equivalents and
investments totaled $113 million and no debt. The Company plans to
provide 2018 guidance during its fourth quarter and year-end 2017
results announcement.
2018 Key Objectives Planned
The Company plans to pursue the following key objectives during
2018:
- Continue enrolling the HER2CLIMB randomized pivotal trial of
tucatinib in locally advanced or metastatic HER2+ breast cancer
with and without brain metastases and provide an update on planned
enrollment completion as appropriate.
- Publish data from two Phase 1b studies of tucatinib in
combination with other approved agents in HER2+ breast cancer in
peer-reviewed journals.
- Report on early interim results from the investigator-initiated
study of tucatinib in HER2+ amplified, metastatic colorectal cancer
known as MOUNTAINEER.
- Pursue PRIME (PRIority MEdicines) designation with the EMA for
tucatinib for the treatment of patients with metastatic colorectal
cancer.
- Complete manufacture of registration lots that will be used to
support the planned filing of a New Drug Application, or NDA, for
tucatinib.
- Identify development partners for Chk1 and TIGIT preclinical
programs.
- Explore potential ex-U.S. partnership opportunities for
tucatinib to support development and commercialization in Europe
and Asia and support funding of a U.S. launch.
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.1,2
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. Tucatinib is also
being studied in other cancers through investigator initiated
studies, including HER2+ metastatic colorectal cancer and earlier
lines of HR+/HER2+ metastatic breast cancer. 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. These
forward-looking statements include Cascadian Therapeutics'
expectations regarding clinical development activities, HER2CLIMB
enrollment, timing of additional data, potential benefits of its
product candidates, and its use and adequacy of cash reserves and
future financings and financial results.
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 to differ materially from those
projected in forward-looking statements, including 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 September 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 does not
undertake any obligation to publicly update its forward-looking
statements based on events or circumstances after the date hereof,
except to the extent required by law.
1 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. 2 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 SABCS Annual Meeting 2016. December 9,
2016 (Poster P4-21-01).
Source: Cascadian Therapeutics, Inc.
Contact:Cascadian TherapeuticsMonique
Greer206-801-2107mgreer@cascadianrx.com
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