Cascadian Therapeutics Announces 2017 Outlook and Recent Drug Portfolio Progress
January 05 2017 - 8:00AM
Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced an overview of recent
progress for its investigational drug portfolio in addition to
several anticipated key objectives for 2017.
“In 2016, we refocused our resources on the development of our
small molecule HER2 inhibitor, tucatinib, and have entered 2017
with clear priorities and with an enhanced team that has late-stage
development experience,” said Scott D. Myers, President and Chief
Executive Officer of Cascadian Therapeutics. “In the fourth quarter
of 2016, following a very collaborative meeting with the FDA, we
amended the ongoing HER2CLIMB Phase 2 trial of tucatinib so that,
if successful, HER2CLIMB could serve as a single pivotal
registration trial. Updated data from the ongoing Phase 1b Triplet
combination study continues to show a tolerable safety profile and
encouraging anti-tumor activity in a heavily pre-treated
population, including those with and without brain metastases. With
a clear, accelerated regulatory pathway for the advancement of
tucatinib in the United States, a solid balance sheet and an
expanded talented leadership team, we plan to spend more time on
our ex-U.S. strategy for tucatinib and to continue building for
success in 2017 and beyond.”
Recent Progress Update
Tucatinib – targeted HER2 inhibitor
- In December 2016, Cascadian announced that following a recent
meeting with the U.S. Food and Drug Administration (FDA) it has
amended the HER2CLIMB Phase 2 clinical trial of its investigational
product, tucatinib, by increasing the sample size so that, if
successful, the trial could serve as a single pivotal study to
support registration. HER2CLIMB is a randomized (2:1),
double-blind, controlled pivotal clinical trial comparing tucatinib
in combination with capecitabine and trastuzumab vs. placebo in
combination with capecitabine and trastuzumab in patients with
locally advanced or metastatic HER2-positive breast cancer who have
had prior treatment with a taxane, trastuzumab, pertuzumab and
T-DM1. The primary endpoint is progression-free survival (PFS)
based upon independent radiologic review, and the sample size is
increased to approximately 480 patients, including patients who
enrolled in HER2CLIMB to date. Patients will also be followed for
overall survival, which is a secondary endpoint. Key objectives
related to assessing activity in brain metastases include a
secondary endpoint of PFS in a subset of patients with brain
metastases.
- In December 2016, researchers presented updated results from
the Company’s ongoing Phase 1b Triplet combination study (tucatinib
with capecitabine and trastuzumab) at the 2016 San Antonio Breast
Cancer Symposium (SABCS). Results showed that tucatinib continues
to be well tolerated in this combination, with an updated median
progression-free survival (PFS) of 7.8 months, an overall response
rate (ORR) of 61 percent and a median duration of response (DoR) of
10 months. Patients treated with the Triplet combination previously
received a median of 3 HER2-targeted agents, such as trastuzumab,
pertuzumab, lapatinib and T-DM1.
CASC-578 - a novel Chk1 cell cycle
inhibitor
During the fourth quarter and during 2016, the following
progress was made in the CASC-578 program:
- Non-GLP repeat dose tolerability studies were conducted in rats
and cynomolgus monkeys to establish drug tolerability and identify
dose ranges to test in future IND enabling GLP toxicology
studies.
- A GLP safety pharmacology study was conducted in cynomolgus
monkeys to evaluate multiple cardiovascular safety endpoints. The
results of this study indicate CASC-578 has an acceptable safety
profile at the doses tested and support further development of the
drug.
- CASC-578 was evaluated in vitro in a large panel of tumor
derived cell lines to define its activity as a single agent in both
solid and hematological cancers and to identify potential
biomarkers to define tumor genotypes most likely to respond to the
drug. The results of this study demonstrated CASC-578 can inhibit
the growth of a subset of tumor derived cell lines from both solid
and hematological malignancies with IC50 values as low as 30 nM and
several candidate biomarkers were identified that correlate with
potency in responsive cell lines.
- To better define the pharmacological activity and therapeutic
index of CASC-578, several in vivo studies were conducted in mice
using human xenograft models of acute leukemia, mantle cell
lymphoma and non-small cell lung cancer. The results of these
experiments showed CASC-578 inhibited, and in some cases, regressed
established tumors as a single agent.
Corporate Update
- In January 2017, the Company announced the appointment of Marc
L. Lesnick, Ph.D., as Senior Vice President, Regulatory Affairs and
Quality.
- As of September 30, 2016, cash, cash equivalents and
investments totaled $71.6 million and no debt. The Company plans to
provide 2017 guidance in its fourth quarter and year-end 2016
results announcement.
2017 Key Objectives Planned
Focus on HER2CLIMB pivotal trial enrollment:
Expand the HER2CLIMB trial to sites in Europe, Australia and Israel
in the first half of 2017.
Report new data at scientific meetings: Report
new data analyses from tucatinib and the Chk1 cell cycle inhibitor
at scientific meetings in 2017.
Explore tucatinib’s utility in other clinical
settings: Support the initiation of select
investigator-sponsored combination trials, including trials in
HER2-positive amplified, metastatic colorectal cancer and in
combination with palbociclib and letrozole in HER2-positive,
hormone-receptor positive metastatic breast cancer.
Define next steps for CASC-578: Complete
pharmacology studies in the first half of 2017 and make go/no-go
decision on IND-enabling studies for CASC-578 in the second half of
2017.
Pursue capital options: Evaluate all available
financing vehicles, including non-dilutive options such as
out-licensing tucatinib regional rights.
About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical
company dedicated to developing innovative product candidates for
the treatment of cancer. The lead investigational product
candidate, tucatinib, also known as ONT-380, is an oral, selective
small molecule HER2 inhibitor. Cascadian Therapeutics is conducting
a pivotal trial named HER2CLIMB to evaluate tucatinib versus
placebo in combination with capecitabine and trastuzumab in
patients with late stage HER2+ breast cancer, with and without
brain metastases. Additional details can be found at
www.clinicaltrials.gov (Identifier: NCT02614794) or
www.HER2CLIMB.com. For more information and to sign up for email
alerts or RSS feeds, 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 and preclinical development
activities, 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 and its ability to adequately obtain and protect its
intellectual property rights. Although Cascadian Therapeutics
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 Cascadian Therapeutics' 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.
Except as required by law, Cascadian Therapeutics does not
undertake any obligation to publicly update its forward-looking
statements based on events or circumstances after the date
hereof.
Additional InformationAdditional information
relating to Cascadian Therapeutics can be found on EDGAR at
www.sec.gov and on SEDAR at www.sedar.com.
Contact:
Monique Greer
Cascadian Therapeutics
206-801-2107
mgreer@cascadianrx.com
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