Program On Track to Begin Dosing in Phase 1B/2
Study of Patients with B-Cell Malignancies in the First Half of
2017
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of results from the Company’s Phase 1A study in
healthy volunteers evaluating oral non-covalent reversible BTK
inhibitor SNS-062. The results were presented in a poster session
titled “CLL: Therapy, excluding Transplantation: Poster I” on
Saturday, December 3, at the 58th American Society of Hematology
Annual Meeting in San Diego, California. The presentation, titled
“First-in-Human Phase 1a Study of the Safety, Pharmacokinetics, and
Pharmacodynamics of the Noncovalent Bruton’s Tyrosine Kinase (BTK)
Inhibitor SNS-062 in Healthy Subjects,” is available at
www.sunesis.com.
“These final results from the Phase 1A Healthy
Volunteer study suggest that SNS-062, with a favorable safety,
pharmacokinetic (PK) and pharmacodynamic (PD) profile, and its
improved PK properties over ibrutinib and acalabrutinib, has
significant potential to become a new treatment option for patients
with B-cell malignancies,” said Linda Neuman, M.D., Vice President,
Clinical Development of Sunesis. “Additionally, as a non-covalent
BTK inhibitor with a distinct reversible binding profile, SNS-062
may overcome the acquired resistance to ibrutinib and other
covalent clinical-stage BTK inhibitors resulting from a point
mutation (C481S) in the active site.”
“The safety profile, extent of SNS-062 exposure,
and duration of BTK inhibition from these study results are
encouraging and support our plans for a Phase 1B/2 study to assess
safety and efficacy in patients with advanced B-cell malignancies
after prior ibrutinib exposure, both with and without a BTK C481
mutation,” said Daniel Swisher, President and Chief Executive
Officer of Sunesis. “We are preparing an IND filing for this year
as we work closely with our identified clinical sites for this
study, and expect to begin dosing patients within the first half of
2017.”
The reported data from this Phase 1A randomized,
double-blind, placebo-controlled, single-dose study are from four
sequential cohorts of 8 subjects each who were randomly assigned to
receive progressively higher single oral administrations of SNS-062
at doses of 25, 50, 100, 200, and 300 mg (n=6 per cohort) or
placebo (n=2 per cohort).
For the primary endpoint of safety in stage 1,
investigators were blinded to treatment arm for assessment of
relatedness. Overall, AEs were reported for 8 (33%) subjects
who received SNS-062 and for 3 (38%) subjects who received placebo.
In the unblinded stages 2 and 3 of the trial, a similar pattern and
rate of AEs were observed. Overall, no obvious pattern of
dose-dependent toxicity was observed. All AEs were transient
and low grade. None of the AEs, laboratory abnormalities, or ECG or
telemetry findings were considered clinically meaningful. No SAEs
were reported.
SNS-062 was rapidly absorbed and had mean plasma
half-life values across all dose cohorts of 6.9 to 17 hours.
SNS-062 demonstrated rapid, profound (~100%), and prolonged
inhibition of BTK at all dose levels support investigation of a
twice-daily dosing regimen in B-cell malignancies with or without
an acquired BTK resistance mutation.
Furthermore in stage 2, food had no impact on
the extent of absorption or elimination of SNS-062, suggesting that
it may be administered to patients without regard to food. In
stage 3, SNS-062, similar to ibrutinib, is a sensitive substrate of
CYP3A4 and administration with moderate/strong CYP3A4 inhibitors or
inducers is not recommended.
About SNS-062
SNS-062 is a novel, second-generation BTK inhibitor, a class of
kinase inhibitors that selectively inhibits the
enzyme Bruton's tyrosine kinase (BTK). This target
mediates signaling through the B-cell receptor, which is critical
for adhesion, migration, proliferation and survival of normal and
malignant B-lineage lymphoid cells. Unlike other drugs in its
class, SNS-062 binds non-covalently and reversibly to the BTK
enzyme. Its binding profile along with improved PK/PD properties
potentially provide SNS-062 an opportunity to address the leading
acquired resistance to ibrutinib, a mutation in the enzyme’s
binding site required for covalent binding. In preclinical studies,
SNS-062 demonstrated potent activity against C481S mutated B-cell
malignancies, and has been studied in healthy subjects in a
completed Phase 1A, randomized, double-blind, placebo-controlled
dose-ranging study to investigate the drug’s safety,
pharmacokinetics, and pharmacodynamics. With the reported
successful study outcome, SNS-062 is proceeding to a Phase 1B/2
study in patients with B-cell malignancies.About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company focused
on the development and commercialization of new oncology
therapeutics for the potential treatment of solid and hematologic
cancers. Sunesis has built a highly experienced cancer drug
development organization committed to improving the lives of people
with cancer. Currently, the company is focused on pursuing
regulatory approval in Europe for its lead product candidate,
vosaroxin, for the treatment of relapsed or refractory acute
myeloid leukemia in patients aged 60 and older, as well as
advancing its novel kinase-inhibitor pipeline, which includes its
proprietary non-covalent BTK-inhibitor, SNS-062.
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 statements related to Sunesis' corporate
objectives, including the regulatory development and potential
approval of vosaroxin by the EMA, potential collaborations and
ability to commercialize vosaroxin in Europe. Words such as
“expect,” “goal,” “may,” "potential" “advancing,” “anticipate,”
“progress” 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 that Sunesis may not be able to receive regulatory approval of
vosaroxin in the U.S. or Europe, that Sunesis' development
activities for vosaroxin could be otherwise halted or significantly
delayed for various reasons, risks related to Sunesis' need for
substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, the
risk that Sunesis' clinical studies for SNS-062, vosaroxin or other
product candidates, including its pipeline of kinase inhibitors,
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 conduct
of Sunesis' clinical trials, 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
vosaroxin and other product candidates. These and other risk
factors are discussed under "Risk Factors" and elsewhere in
Sunesis' Annual Report on Form 10-K for the year
ended December 31, 2015, Sunesis’ Quarterly Report on Form
10-Q for the quarter ended September 30, 2016, 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
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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