Sunesis Pharmaceuticals Announces Presentation of Preliminary Data from Phase 1b/2 Trial of Vecabrutinib in Patients with CLL...
June 15 2019 - 11:30AM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced the
presentation of results from the Company’s Phase 1b/2 clinical
trial of its non-covalent BTK inhibitor vecabrutinib in adults with
relapsed/refractory chronic lymphocytic leukemia (CLL) and other
B-cell malignancies. The results are being presented
today, June 15, from 5:30-7:00 p.m. CET in a poster
session titled “Chronic lymphocytic leukemia and related disorders
– Clinical” at the 24th Congress of the European Hematology
Association (EHA) in Amsterdam. The poster, titled
“Preliminary Results of a Phase 1b/2 Dose-Escalation and
Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s
Tyrosine Kinase Inhibitor (BTKi) Vecabrutinib in B-Cell
Malignancies,” Abstract No. PS1148, is available at
www.sunesis.com.
“We are encouraged by the data presented today
demonstrating vecabrutinib’s well-tolerated safety profile and
evidence of clinical activity in CLL and other B-cell malignances,”
said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis.
“Importantly, vecabrutinib’s median steady-state trough
concentrations continue to increase with dose and are approaching
levels expected to provide consistent BTK inhibition and greater
clinical activity. We are currently dosing patients in the 200mg
cohort and momentum in the trial continues as reflected by the
robust pace of enrollment we’ve seen this year. We look forward to
sharing data from the additional cohorts as we complete the Phase
1b and proceed to Phase 2 later this year.”
Preliminary data reported today were available
from 23 patients treated in the trial thus far. These included 19
CLL patients, two mantle cell lymphoma (MCL) patients, and two
Waldenstrom Macroglobulinemia (WM) patients. Patients
had received an average of 4 lines of prior therapy, and all
patients had progressed on prior BTKi therapy. 61% of CLL patients
enrolled had a BTK C481 mutation as of the data cutoff for the
poster.
The poster builds vecabrutinib’s profile in four
key areas:
-
Safety: Preliminary data on
treatment-emergent adverse events (TEAEs) were available for 20
patients. The most common TEAEs of any grade were anemia (40%) and
neutropenia and night sweats (30% each), with 5 drug-related Grade
3 adverse events occurring in 3 patients, all in cohort 2 (50mg).
In total, there were 8 serious adverse events (SAEs) in six
patients, none of which were considered drug-related.
-
Activity: Stable disease was seen in 4 CLL
patients, 3 of whom had BTK C481S mutations. Two of these patients,
both with BTK C481S mutations, showed decreases of 16% and 47% in
index lesions at first assessment by CT scans. The patient with the
47% decrease was one of two evaluable post-venetoclax patients with
the BTK C481S mutation. A patient with WM experienced clinical
benefit with improvement in B-symptoms but no impact on
immunoglobulin M. One patient in cohort 3 (100mg) continues on
treatment in cycle 6 (as of the poster data cutoff, this patient
was in cycle 5).
-
Pharmacokinetics: The pharmacokinetic profile
of vecabrutinib showed sustained exposure over the dosing interval,
with median steady-state trough concentrations increasing with
dose. Preliminary data showed near doubling of trough
concentrations between doses of 50 mg (451 ng/mL) and 100 mg (873
ng/mL). Based on the results of the Phase 1A study in healthy
subjects, trough levels of >1,000 ng/mL are expected to be
required for consistent BTK inhibition and greater clinical
activity. This is likely achievable with doses higher than 100 mg
BID.
- Pharmacodynamics:
Vecabrutinib inhibition of BTK phosphorylation was rapid and
sustained in patients who had adequate baseline signal for
analysis. Decreases in serum concentrations of key cytokines
associated with B-cell malignancies, CCL2, CCL3, and CCL4, were
observed in most evaluable patients, consistent with inhibition of
BTK signaling.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company
developing new targeted therapeutics for the treatment of
hematologic and solid cancers. Sunesis has built an experienced
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 its oral
non-covalent BTK inhibitor vecabrutinib. Vecabrutinib is currently
being evaluated in a Phase 1b/2 study in adults with chronic
lymphocytic leukemia and other B-cell malignancies that have
progressed after prior therapies. The Company’s proprietary PDK1
inhibitor SNS-510 is in preclinical development. 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.
Sunesis is exploring strategic alternatives for vosaroxin, a
late-stage investigational product for relapsed or refractory AML.
Sunesis also has an interest in the pan-RAF inhibitor TAK-580 which
is licensed to Takeda. TAK-580 is in a clinical trial for pediatric
low-grade glioma.
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’ continued
development of vecabrutinib (SNS-062), including the timing of the
Phase 1b/2 trial of vecabrutinib,the therapeutic potential of
vecabrutinib, and the further development and potential of its
kinase inhibitor pipeline. Words such as “believe”, “expect,”
“likely,” “look forward” 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, 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, 2019
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 |
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Willie QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
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