FDA Review of Investigational New Drug
Application for SNS-062 Complete; Phase 1B/2 Study in Patients with
Advanced B-Cell Malignancies to Begin Dosing in the First Half of
2017
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced
clinical and regulatory updates to its two lead programs, SNS-062,
a second-generation reversible and non-covalent BTK inhibitor, and
vosaroxin, an anti-cancer quinolone derivative currently under
review for marketing authorization as a treatment for
relapsed/refractory acute myeloid leukemia (AML) in Europe.
For SNS-062, the company announced that its
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) is now active, supporting the initiation
of a Phase 1B/2 study to assess the candidate's safety and efficacy
in patients with advanced B-cell malignancies after prior ibrutinib
exposure, including in patients with C481S mutations.
“With a now active IND for SNS-062, another
important milestone in the rapid development of this next
generation product candidate, we will work toward site
activation at our U.S. clinical centers and dosing of the
first patients within the first half of 2017,” said Daniel Swisher,
President and Chief Executive Officer of Sunesis. “The data
presented at ASH from our Phase 1A Healthy Volunteer study were
encouraging, and we look forward to understanding the potential for
SNS-062 to address the growing unmet needs of patients with B-cell
malignancies.”
The company also announced today continued progress
with its Marketing Authorization Application (MAA) for vosaroxin.
Sunesis recently received the Day 180 List of Outstanding Issues,
issued by the Committee for Medicinal Products for Human
Use (CHMP) as part of the centralized review process.
Mr. Swisher continued, “We are working diligently
to complete a comprehensive and detailed response to the Day 180
List of Outstanding Issues, which we expect to submit by the end of
the first quarter. As we enter the final phase of the European
approval process for vosaroxin, we are preparing to go before the
Scientific Advisory Group’s Oncology Division (SAG-O) in April,
which will assist the CHMP in its evaluation of our application. We
anticipate a decision from the CHMP by mid-year and continue to
advance active dialogues with potential pharma collaborators toward
the goal of supporting a market launch of vosaroxin in 2017.”
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 QINPREZO™
(vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone
derivative (AQD), a class of compounds that has not been used
previously for the treatment of cancer. Preclinical data
demonstrate that vosaroxin both intercalates DNA and inhibits
topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Both
the U.S. Food and Drug Administration (FDA)
and European Commission have granted orphan drug
designation to vosaroxin for the treatment of AML. Vosaroxin is an
investigational drug that has not been approved for use in any
jurisdiction.
Vosaroxin’s Marketing Authorization Application for
relapsed refractory AML is currently under review by
the European Medicines Agency, and a regulatory decision
regarding approval is expected in 2017.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name
for the vosaroxin drug product candidate.
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, the regulatory development, timing of SNS-062 clinical
development, SNS-062 clinical potential, Sunesis’ response to Day
180 List of Outstanding Issues and the timing thereof, and
potential approval of vosaroxin by the EMA, potential
collaborations and ability to commercialize vosaroxin
in Europe. Words such as “advancing,” “anticipate,” “expect,”
“goal,” “look forward,” "potential" “progress,” “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 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, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of SNS-062, 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 SNS-062, 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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