Verastem Enters Biomarker Agreement with LabCorp for Cancer Stem Cell Agent Companion Diagnostic
Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical
company focused on discovering and developing drugs to treat cancer by
the targeted killing of cancer stem cells, entered an agreement with
Laboratory Corporation of America® Holdings (LabCorp®)
(NYSE: LH) to validate biomarkers for its lead focal adhesion kinase
(FAK) inhibitor VS-6063 in the development of an applicable companion
diagnostic.
The biomarkers will be the subject of clinical studies in ovarian cancer
and mesothelioma, including a potentially pivotal study of VS-6063 in
mesothelioma expected to initiate later this year.
“The identification of patients most likely to benefit from targeted
therapy is critical to accelerating the drug development and approval
process,” said Henri Termeer, Verastem Lead Director.
Clinical assay validation is an integral component to all companion
diagnostics entering an FDA approval process.
Pioneering research by Robert Weinberg, Ph.D., Verastem cofounder and
chair of the Scientific Advisory Board, and others have demonstrated
that FAK signaling plays a central role in the tumor-initiating
capability of cancer stem cells and ultimate disease progression.
VS-6063 is designed to target and kill cancer stem cells by inhibiting
FAK signaling.
Mesothelioma tumors lacking the tumor suppressor Merlin appear to
be particularly sensitive to FAK inhibitors. As shown recently at the
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics,
sensitivity due to lack of Merlin is evident in both research models and
early clinical proof-of-concept.
“We believe the approximately 50% of mesothelioma patients lacking
Merlin may be particularly responsive to treatment with FAK inhibitors,”
said Dan Paterson, Verastem Vice President, Head of Corporate
Development and Diagnostics. “LabCorp is the perfect partner to progress
our research on Merlin into a companion diagnostic for VS-6063.”
“We are pleased to collaborate with Verastem in guiding the clinical
development of cancer stem cell-targeted agents,” said David P. King,
Chairman and Chief Executive Officer of LabCorp. “This relationship
represents another example of our accelerating initiatives in companion
diagnostics and personalized medicine.”
About VS-6063
VS-6063 is an oral small molecule inhibitor of focal adhesion kinase
(FAK) which is a critical pathway for cancer stem cells. VS-6063 was
well-tolerated and demonstrated signs of clinical activity in a Phase 1
study in advanced solid tumors. Verastem has demonstrated that loss of
the tumor suppressor Merlin confers increased susceptibility to FAK
inhibition. Verastem is planning to initiate multiple clinical trials in
2013 with VS-6063 including a potentially pivotal study in mesothelioma.
About Verastem, Inc.
Verastem, Inc. (NASDAQ: VSTM) is a clinical-stage biopharmaceutical
company focused on 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, PI3K/mTOR
and Wnt. 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 of the Company’s compounds, including VS-6063,
and the Company’s FAK and diagnostic programs generally, the timeline
for clinical development and regulatory approval of the Company’s
compounds and the structure of the Company’s planned clinical trials.
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 compounds may
not be predictive of the success of later clinical trials, that the
Company will be unable to successfully complete the clinical development
of its compounds, including VS-6063, that the development of the
Company’s compounds will take longer or cost more than planned, and that
the Company’s compounds 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, 2011 and in
any subsequent SEC filings. The forward-looking statements contained in
this presentation 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.