Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing
drugs to treat cancer by the targeted killing of cancer stem cells,
today announced oral and poster presentations at the 16th World
Conference on Lung Cancer (WCLC) which took place September 6 - 9, 2015,
in Denver, CO.
Four oral presentations included results from a Phase 2 clinical trial
of VS-6063 (defactinib) in advanced refractory KRAS-Mutated Non-Small
Cell Lung Cancer (NSCLC) and presentations on preclinical studies of
VS-6063 and VS-5584 in Small-Cell Lung Cancer (SCLC) and Mesothelioma.
Two poster presentations detailed trial designs for Verastem’s ongoing
COMMAND trial in mesothelioma and Phase 1 dose-escalation study of
VS-5584 in advanced solid tumors.
Verastem presented these clinical and preclinical data at WCLC in
support of its programs targeting cancer stem cells (CSCs) through
inhibition of the focal adhesion kinase (FAK; VS-6063) and PI3K/mTOR
(VS-5584) signaling pathways. Research on the FAK and PI3K/mTOR
signaling pathways has revealed critical roles for each in determining
CSC survival and disease progression. CSCs represent a subpopulation of
cancer cells that have tumor-initiating capability, are particularly
resistant to chemotherapy and can mediate tumor recurrence both locally
and at metastatic sites.
Details and links to the data presentations at WCLC are below:
Oral Presentations
Title: Phase 2 study of
defactinib, VS-6063, a focal adhesion kinase (FAK) inhibitor, in
patients with KRAS mutant non-small cell lung cancer (NSCLC)
Session
info: Mini oral 30: New Kinase Targets; Track: Treatment of Advanced
Diseases – NSCLC
Link to slides from the oral presentation: http://bit.ly/R3M6wc
Title: The cancer stem cell inhibitors VS-6063 (defactinib) and
VS-5584 exhibit synergistic anticancer activity in pre-clinical models
of mesothelioma
Session info: Oral session 40: Biology 1;
Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
Link
to slides from the oral presentation: http://bit.ly/R3M6wc
Title: Targeting Cancer Stem Cells in Small Cell Lung Cancer
Session
info: Mini oral 27: Biology and other issues in SCLC; Track: Small
Cell Lung Cancer
Link to slides from the oral presentation: http://bit.ly/R3M6wc
Title: FAK inhibitor VS-6063 targets mesothelioma cancer stem
cells: Rationale for maintenance therapy after conventional chemotherapy
Session
info: Mini oral 38: Biology and Prognosis; Track: Thymoma,
Mesothelioma and Other Thoracic Malignancies
Link to slides from
the oral presentation: http://bit.ly/R3M6wc
Poster Presentations
Title: COMMAND: A Phase 2 randomized, double-blind, study of
defactinib (VS-6063) as maintenance therapy in malignant pleural
mesothelioma
Poster #: P3.08.014
Session info:
Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma
Link
to copy of the poster presentation: http://bit.ly/R3M6wc
Title: A Phase 1 dose escalation study of VS-5584, a PI3K/mTOR
inhibitor, administered with VS-6063, a focal adhesion kinase inhibitor,
in mesothelioma
Poster #: P2.08.008
Session info:
Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma
Link
to copy of the poster presentation: http://bit.ly/R3M6wc
About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target
cancer stem cells through the potent inhibition of focal adhesion kinase
(FAK). Cancer stem cells are an underlying cause of tumor resistance to
chemotherapy, recurrence and ultimate disease progression. Research has
demonstrated that FAK activity is critical for the growth and survival
of cancer stem cells. VS-6063 is currently being studied in the
registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com),
a “Window of Opportunity” study in patients with mesothelioma prior to
surgery, a Phase 1/1b study in combination with paclitaxel in patients
with ovarian cancer, a trial in patients with Kras-mutated non-small
cell lung cancer and a trial evaluating the combination of VS-6063 and
VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted
orphan drug designation for use in mesothelioma in the U.S. and EU.
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and
highly selective activity against class 1 PI3K enzymes and dual
inhibitory actions against mTORC1 and mTORC2. In preclinical studies,
VS-5584 has been shown to reduce the percentage of cancer stem cells and
induce tumor regression in chemotherapy-resistant models. Verastem is
currently conducting a dose escalation trial of VS-5584 in patients with
advanced solid tumors as a single agent and a combination trial of
VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has
been granted orphan drug designation for use in mesothelioma in the U.S.
and EU.
About Verastem, Inc.
Verastem, Inc. (NASDAQ:VSTM) is discovering and developing drugs to
treat cancer by the targeted killing of cancer stem cells. Cancer stem
cells are an underlying cause of tumor recurrence and metastasis.
Verastem is developing small molecule inhibitors of signaling pathways
that are critical to cancer stem cell survival and proliferation: FAK
and PI3K/mTOR. For more information, please visit www.verastem.com.
Forward-looking statements:
This press release includes forward-looking statements about the
Company’s strategy, future plans and prospects, including statements
regarding the development and activity of the Company’s product
candidates, VS-6063and VS-5584, and the Company’s FAK, PI3K/mTOR and
diagnostics programs generally, the structure of our planned or pending
clinical trials and additional planned studies. The words “anticipate,”
“appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,” “could,”
“should,” “continue,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. Each forward-looking statement is
subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks that the
preclinical testing of the Company’s product candidates and preliminary
or interim data from clinical trials may not be predictive of the
results or success of ongoing or later clinical trials, that data may
not be available when we expect it to be, that enrollment of clinical
trials may take longer than expected, that our product candidates will
cause unexpected safety events, that the Company will be unable to
successfully initiate or complete the clinical development of its
product candidates, that the development of the Company’s product
candidates will take longer or cost more than planned, and that the
Company’s product candidates will not receive regulatory approval or
become commercially successful products. Other risks and uncertainties
include those identified under the heading “Risk Factors” in the
Company’s Annual Report on Form 10-K for the year ended December 31,
2014 and in any subsequent SEC filings. The forward-looking statements
contained in this press release reflect the Company’s current views with
respect to future events, and the Company does not undertake and
specifically disclaims any obligation to update any forward-looking
statements.
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