Sunesis Pharmaceuticals Announces First Patient Dosed in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 ...
July 18 2017 - 4:05PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the first patient has been dosed at the Dana-Farber Institute in
the Phase 1b/2 dose-escalation and cohort-expansion study of its
reversible, non-covalent Bruton’s Tyrosine Kinase (BTK)-inhibitor,
SNS-062, in adults with chronic lymphocytic leukemia (CLL), small
lymphocytic leukemia, Waldenstrom’s macroglobulinemia and mantle
cell lymphoma that have progressed after prior therapies.
“Resistance to ibrutinib, the only FDA approved
BTK inhibitor, is a growing area of unmet need in the treatment of
relapsed CLL,” said Dr. Jennifer Brown, Director of the CLL Center
at Dana-Farber Cancer Institute. “SNS-062 is designed to retain its
activity in the presence of the C481S mutation, the primary
resistance mechanism thus far identified to treatment by
covalent-binding BTK inhibitors such as ibrutinib. We look forward
to participating in Sunesis’ Phase 1b/2 study to explore the
therapeutic potential of SNS-062.”
“The start of this Phase 1b/2 study marks a
significant milestone for the Company,” said Daniel Swisher, Chief
Executive Officer of Sunesis. “This study is designed to provide
initial proof of concept that SNS-062 can become a new treatment
option for patients with relapsed CLL. We look forward to
progressing this trial to identify a recommended dose and to
characterize the profile of SNS-062 across a range of B-cell
malignancies.”
The Phase 1b/2 trial is an open-label,
sequential-group study that will enroll up to 124 subjects and is
being conducted at five leading sites in the United States:
Dana-Farber Cancer Institute, MD Anderson Cancer Center, The Ohio
State University Comprehensive Cancer Center, U.C. Irvine Medical
Center, and Weill Cornell Medicine. The target population comprises
adult subjects who have advanced B-cell malignancies that have
relapsed/progressed after prior therapy, including a BTK inhibitor.
Phase 1b is the dose escalation portion of the study designed to
evaluate the safety, pharmacokinetics, pharmacodynamics and
antitumor activity of a range of SNS-062 dose levels, to determine
the maximum tolerated and/or recommended dose. The Phase 2 portion
is the cohort expansion that will further explore the clinical
activity and safety of SNS-062 mono-therapy within specific disease
cohorts, including relapsed CLL patients with C481S mutations.
About SNS-062
SNS-062 is a selective, oral, reversible,
non-covalent inhibitor of Bruton's tyrosine kinase (BTK). BTK
is a validated target for the treatment of B-cell malignancies
driven by B-cell receptor signaling. SNS-062 is designed to retain
its activity in the presence of a C481S mutation in BTK’s kinase
domain, a leading resistance mechanism of ibrutinib for the
treatment of chronic lymphocytic leukemia (CLL). In preclinical
studies, SNS-062 demonstrated potent activity in both wild-type and
C481S mutant BTK. In a Phase 1A randomized, double-blind,
placebo-controlled single ascending dose study in healthy
volunteers, SNS-062 demonstrated improved pharmacokinetics over
ibrutinib, and sustained inhibition of BTK. SNS-062 is now being
investigated in a Phase 1B/2 study in patients with relapsed B-cell
malignancies, including CLL.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company focused
on the development and commercialization of new oncology
therapeutics for the future treatment of solid and hematologic
cancers. Sunesis has built an experienced cancer drug development
organization committed to improving the lives of people with
cancer. The company is focused on advancing its novel
kinase-inhibitor pipeline, with an emphasis on establishing proof
of concept that its oral non-covalent BTK-inhibitor, SNS-062,
treats ibrutinib-resistant chronic lymphocytic leukemia. Sunesis is
also supporting investigator-led studies of vosaroxin in acute
myeloid leukemia.
For additional information on Sunesis, please
visit http://www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including clinical development and therapeutic
potential of SNS-062, including the design and timing of our Phase
1b/2 trial. Words such as “can,” “designed,” “look forward,” “will”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
Sunesis' current expectations. Forward-looking statements involve
risks and uncertainties. Sunesis' actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation risks related to
the timing or conduct of Sunesis' clinical trials, including
SNS-062 Phase 1b/2 trial, the risk that Sunesis' clinical studies
for SNS-062, vosaroxin or other product candidate may not
demonstrate safety or efficacy or lead to regulatory approval, the
risk that data to date and trends may not be predictive of future
data or results, the risk that Sunesis may not be able to receive
regulatory approval of SNS-062 or vosaroxin in the U.S.
or Europe, that Sunesis' development activities for SNS-062 or
vosaroxin could be otherwise halted or significantly delayed for
various reasons, and risks related to Sunesis' ability to raise the
capital that it believes to be accessible and is required to fully
finance the development and commercialization of SNS-062, vosaroxin
and other product candidates. These and other risk factors are
discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly
Report on Form 10-Q for the quarter ended March 31, 2017 and
Sunesis' other filings with the Securities and Exchange
Commission. Sunesis expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Sunesis' expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Dan Swisher
Sunesis Pharmaceuticals Inc.
650-266-3715
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