Sunesis Pharmaceuticals Announces Advancement into 100mg Cohort of Phase 1b/2 Trial of Vecabrutinib in Patients with CLL and ...
January 02 2019 - 7:00AM
- 50 mg Cohort Completed -
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the Company has opened the 100 mg cohort in the Phase 1b/2 trial of
its non-covalent BTK inhibitor vecabrutinib in adults with
relapsed/refractory chronic lymphocytic leukemia (CLL) and other
B-cell malignancies. Preliminary safety, pharmacokinetic, and
pharmacodynamic data from the now completed 50 mg cohort of the
study were recently presented at the 60th American Society of
Hematology (ASH) Annual Meeting in December 2018.
“We are excited to study the 100 mg dose level
as we continue the dose escalation portion of this study,” said
Dayton Misfeldt, Sunesis interim Chief Executive Officer. “Thus
far, we have seen an encouraging safety profile, evidence of
pharmacodynamic activity in CLL and other B cell cancer patients
both with and without BTK C481 mutations, and some improvements in
clinical symptoms. We anticipate that the target dose level for
vecabrutinib will likely be between 100 mg and 300 mg BID and look
forward to providing a clinical update on potentially active dose
levels at a major medical meeting in the second quarter of
2019.”
About Vecabrutinib
Vecabrutinib (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.
Vecabrutinib has potent activity in vitro against both wild-type
and C481S-mutant BTK. BTKC481S is the most common mutation
seen in ibrutinib-resistant CLL patients. Vecabrutinib also
inhibits IL2-inducible T-cell kinase (ITK), which may improve T
cell function. In a Phase 1a randomized, double-blind,
placebo-controlled single ascending dose study in healthy
volunteers, vecabrutinib demonstrated improved pharmacokinetics
over ibrutinib, and sustained inhibition of BTK. Vecabrutinib is
now being investigated in a Phase 1b/2 study in patients with
relapsed CLL and other B-cell malignancies.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company
developing new therapeutics for the treatment of hematologic and
solid cancers. Sunesis has built an experienced 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 its oral non-covalent BTK
inhibitor vecabrutinib. Vecabrutinib is currently being evaluated
in a Phase 1b/2 study in adults with chronic lymphocytic leukemia
and other B-cell malignancies that have progressed after prior
therapies. The Company’s proprietary PDK1 inhibitor SNS-510 is in
preclinical development. PDK1 is a master kinase that activates
other kinases important to cell growth and survival including
members of the AKT, PKC, RSK, and SGK families. Sunesis is
exploring strategic alternatives for vosaroxin, a late-stage
investigational product for relapsed or refractory AML. Sunesis
also has an interest in the pan-RAF inhibitor TAK-580 which is
licensed to Takeda. TAK-580 is in a clinical trial for pediatric
low-grade glioma.
For additional information on Sunesis, please
visit www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis
Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to the continued
development of vecabrutinib (SNS-062), including the timing and
preliminary results of Phase 1b/2 trial of vecabrutinib and the
therapeutic potential of vecabrutinib, further development and
potential of its kinase inhibitor pipeline, and planned development
of SNS-510 and TAK-580. Words such as “believe,” “expect,”
“future,” “look forward,” “potential,” “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, the risk related
to the timing or conduct of Sunesis' clinical trials, including the
vecabrutinib Phase 1b/2 trial, the risk that Sunesis' clinical or
preclinical studies for vecabrutinib, SNS-510 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, risks related to the
timing or conduct of Sunesis' clinical trials, that Sunesis'
development activities for vecabrutinib or SNS-510 could be
otherwise halted or significantly delayed for various reasons, that
Sunesis may not be able to receive regulatory approval of
vecabrutinib, or SNS-510 in the U.S. or Europe, 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 vecabrutinib, SNS-510 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 September 30, 2018 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 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:Maeve ConneightonArgot Partners212-600-1902 |
Willie
QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
|
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