Sunesis Pharmaceuticals Announces Presentations at the EHA Annual Meeting
June 18 2018 - 7:00AM
Université Claude Bernard de Lyon Study Provides
Preclinical Validation of Vecabrutinib Activity Against
Ibrutinib-Resistant BTK C481S Mutated Lymphomas
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced two
presentations at the 23rd Congress of the European Hematology
Association (EHA) in Stockholm, Sweden. Preclinical data from the
laboratory of Professor Gilles Salles at the Université Claude
Bernard de Lyon demonstrated the activity of Sunesis’ non-covalent
BTK inhibitor vecabrutinib in BTK-dependent lymphomas, including
lymphoma cell lines overexpressing mutated BTK C481S. In addition,
a Sunesis-supported study led by the European Research Initiative
on CLL (ERIC) assessed the real-world prevalence of BTK C481 and
PLCg2 mutations in CLL patients relapsing under ibrutinib.
Approximately half of the relapsed patients had BTK C481S
mutations.
“Vecabrutinib demonstrated the ability to
selectively induce apoptosis in BTK-dependent lymphoma cell lines,
and to overcome resistance conferred by the BTK C481S mutation,”
said Doctor Pierre Sujobert, lead investigator on the vecabrutinib
study. “Based on our work, vecabrutinib seems to be a good
potential option for patients with B-lymphoid malignancies who
develop the C481S mutation and subsequent resistance to
ibrutinib.”
“This real-world study confirms that there
exists a high frequency of mutations within the Bruton’s tyrosine
kinase (BTK) gene at C481, the binding site for ibrutinib, as well
as the rarer PLCg2 gene, in CLL patients relapsing under
ibrutinib,” said Professor Paolo Ghia, President of ERIC and senior
author of the abstract. “These results indicate the outgrowth of
several resistant clones and suggest resistance mechanisms that
need to be studied further. With around 50% of relapsed patients
carrying BTK 481S mutations, there is a strong rationale for the
development of a new, innovative treatment to improve outcomes for
these patients.”
“We are encouraged by the preclinical data from
the laboratory of Professor Salles, which demonstrates
vecabrutinib’s activity against ibrutinib-resistant BTK C481S
mutated lymphomas,” said Judy Fox, Ph.D., Chief Scientific Officer
of Sunesis. “Furthermore, the ERIC effort promoted by Professor
Ghia supports earlier reports on the prevalence of BTK C481
mutations in CLL patients who relapse on the covalent BTK inhibitor
ibrutinib. With its non-covalent binding mechanism, we believe
vecabrutinib represents an important potential new treatment option
for patients with CLL and other B-cell hematologic cancers. We
remain focused on the execution of the Phase 1b portion of our
ongoing trial with vecabrutinib, a dose escalation study evaluating
the safety, pharmacokinetics, pharmacodynamics, and antitumor
activity over a range of dose levels to determine the maximum
tolerated and/or recommended dose, and we are on track to reach
that recommended Phase 2 dose this fall.”
The vecabrutinib study, titled, “Preclinical
Validation of Vecabrutinib (SNS-062) Efficiency Against BTK-C481S
Mutated Lymphomas” was presented in the Aggressive Non-Hodgkin
Lymphoma – nonclinical poster session Friday, June 15, by Dr.
Camille Libre, a fellow in the laboratory of Dr. Pierre Sujobert at
the Université Claude Bernard de Lyon. The ERIC study, titled “Half
of Chronic Lymphocytic Leukemia Patients Relapsing Under Ibrutinib
Carry BTK and PLCG2 Mutations: A European Research Initiative on
CLL (ERIC) Real-World Study,” was presented by Dr. Lydia Scarfo, a
senior researcher in the group of Professor Paolo Ghia of the San
Raffaele Research Institute in Milan, as an oral presentation in
the late-breaker session of the meeting on Sunday, June 17. The
vecabrutinib poster is available at www.sunesis.com.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company
developing new therapeutics for the 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 BTK-inhibitor vecabrutinib is
effective in ibrutinib-resistant chronic lymphocytic leukemia.
Vecabrutinib is currently being evaluated in a Phase 1b/2 study in
adults with chronic lymphocytic leukemia and other B-cell
malignancies who have progressed after prior therapies. Beyond the
development of vecabrutinib, the Company has two other kinase
inhibitor programs, including the Takeda-partnered pan-RAF
inhibitor TAK-580, which is in clinical trials for solid tumors,
and Sunesis’ proprietary preclinical PDK1 inhibitor SNS-510, which
is in preclinical development with an IND submission planned in
2019. 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.
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 Sunesis’ cash
sufficiency forecast, the continued development of vecabrutinib
(SNS-062), including the timing 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. Words such as “believe,” “expect,” “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 March 31, 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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