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Press Release – Sunesis Pharmaceuticals

Sunesis Pharmaceuticals Announces First Patient Dosed in Phase 1b:2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia and other B-Cell Malignancies Nasdaq:SNSS
July 18, 2017 16:05 ET | Source: Sunesis Pharmaceuticals Inc
SOUTH SAN FRANCISCO, Calif., July 18, 2017 (GLOBE NEWSWIRE) — 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, placebocontrolled
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 BTKinhibitor,
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

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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