Sunesis Pharmaceuticals Announces Withdrawal of European Marketing Authorization Application (MAA) for Vosaroxin as a Treatme...
May 01 2017 - 4:30PM
Company’s Primary Development Focus is
Non-Covalent Reversible BTK-Inhibitor SNS-062
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) announced today that
the Company will withdraw its European Marketing Authorization
Application (MAA) for vosaroxin as a treatment for
relapsed/refractory acute myeloid leukemia (AML) in patients aged
60 years and older. The decision follows recent interactions with
the European Medicine Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP), during which the Company learned
that the committee was likely to formally adopt a negative opinion
in its evaluation of the application.
“We are disappointed to not achieve approval for
vosaroxin’s MAA given its reported efficacy in a patient population
with such poor outcomes. Although we did not receive a
definitive CHMP opinion, we believed that a positive opinion was
unlikely,” said Daniel Swisher, President and Chief Executive
Officer of Sunesis. “Following our appearances before the
committee’s Scientific Advisory Group Oncology and CHMP, we
carefully considered feedback from our rapporteurs and input from
retained regulatory experts to make our decision to notify EMA to
withdraw vosaroxin’s MAA as our assessment concluded it was
unlikely we could achieve a majority vote of CHMP members at this
time or upon an immediate re-examination for our proposed
indication based on VALOR data from a sub-group of a single pivotal
trial that had missed reaching full statistical significance in its
primary analysis.”
Mr. Swisher added: “In light of this, we are
significantly reducing our investment in the AML program and
shifting an increasing portion of resources to our kinase inhibitor
pipeline, including lead asset SNS-062, our non-covalent reversible
BTK-inhibitor, which will begin dosing this quarter in a Phase 1b/2
trial in cancer patients with B-cell malignancies. We expect to
continue to advance the development of vosaroxin through a modest
investment in investigator-sponsored group trials, and will
carefully assess business development alternatives to support the
conduct of another pivotal trial to achieve future regulatory
approval of vosaroxin. We expect that our current cash resources
are sufficient to fund the company beyond Q1 2018.”
Conference Call Information
Sunesis will host a conference call in
conjunction with first quarter 2017 financial results on
Monday, May 8th at 11:00 a.m. Eastern Time. The call
can be accessed by dialing (844) 296-7720 (U.S. and Canada) or
(574) 990-1148 (international) and entering passcode 13018661. To
access the live audio webcast, or the subsequent archived
recording, visit the “Investors and Media – Calendar of Events”
section of the Sunesis website at www.sunesis.com. The
webcast will be recorded and available for replay on the company’s
website for two weeks.
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 has a distinct kinase selectivity profile and binds
non-covalently to the BTK enzyme. This alternate binding site
potentially provides an opportunity to address the leading
resistance mechanism, a mutation in the enzyme’s binding site
required for covalent binding. In preclinical studies, SNS-062
demonstrated potent activity against Cys-481S mutated B-cell
malignancies, and has been studied in healthy subjects in a 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. Additionally,
vosaroxin has been granted fast track designation by
the FDA for the potential treatment of
relapsed/refractory AML in combination with cytarabine. Vosaroxin
is an investigational drug that has not been approved for use in
any jurisdiction. 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 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 the continued
development and commercialization of vosaroxin, the timing of our
Phase 1b/2 trial of SNS-062, and the sufficiency of Sunesis’ cash
and funding through Q1 2018. Words such as “advance,” “continue,”
“expect,” “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
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 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, 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
Dan Swisher
Sunesis Pharmaceuticals Inc.
650-266-3715
Sunesis Pharmaceuticals (NASDAQ:SNSS)
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