Mike Crowther Appointed Chief Commercial and
Business Strategy Officer
David Mitchell Appointed Senior Vice President,
Head of Regulatory Affairs
Dan Calkins Promoted to Chief Financial Officer
from Vice President of Finance
Verastem Oncology (Nasdaq: VSTM) (the “Company”), a
biopharmaceutical company committed to advancing new medicines for
patients with cancer, announced today new executive leadership team
appointments in advance of the Company’s potential commercial
launch of avutometinib in combination with defactinib in low-grade
serous ovarian cancer (LGSOC) and to support the advancement of its
broader development program in RAS pathway-driven cancers.
"These leadership appointments bring significant experience in
oncology regulatory and commercial success as well as deep
financial expertise as we move to the next stage of the Company’s
development. This includes filing for accelerated approval for
avutometinib and defactinib in LGSOC and preparing for a commercial
launch of this potential first FDA-approved medicine for this
patient population," stated Dan Paterson, President and Chief
Executive Officer of Verastem Oncology. "This strengthened
executive team, combined with Verastem’s significant progress in
advancing therapies across RAS pathway-driven cancers, is expected
to accelerate our work to bring new therapies to patients with high
unmet medical need."
Mike Crowther, Chief Commercial and Business Strategy Officer,
brings more than 20 years of commercial, marketing, and business
operations experience at a local, regional, and global level. He
was most recently the Chief Business Officer at Minerva
Biotechnologies, leading business results in immunotherapies for
cancer treatment and executive leader for strategic planning,
business development, and commercial operations. Prior to that, Mr.
Crowther was the Interim U.S. Lead and Vice President of U.S.
Marketing at Kite Pharma where he was responsible for strategic
marketing and business operations. Previously, he was in positions
of increasing leadership within Global Marketing at Celgene where
he led commercial strategy and execution across several therapeutic
areas, including the preparation and launch of 10 oncology
products. He received his Bachelor of Science at the Manchester
Metropolitan University in Manchester, United Kingdom.
David Mitchell, Senior Vice President and Head of Regulatory
Affairs, has more than 45 years of experience in the development of
treatments in oncology, rare diseases, and other therapeutic areas.
He was most recently the Senior Vice President and Head of
Regulatory Affairs at Sumitovant Biopharma. Prior to Sumitovant, he
served as Head of Regulatory for Roivant Sciences, VP of Regulatory
and Quality at Aeglea Pharmaceuticals, VP of Regulatory and Quality
at Aquinox Pharmaceuticals, and Global Regulatory Lead and Director
of Regulatory Affairs in Oncology at AbbVie. Mr. Mitchell has been
the regulatory leader in the development of more than 150
Investigational New Drug applications, 12 New Drug Applications and
Biologic License Applications and has led a multitude of meeting
requests and briefing packages for formal meetings with the U.S.
Food and Drug Administration, European Medicines Agency and other
global health authorities. Mr. Mitchell obtained his Master of
Science in Regulatory Science from the Johns Hopkins University and
his Bachelor of Science in Chemistry from MS College in Clinton,
Mississippi.
Dan Calkins, Chief Financial Officer, joined Verastem Oncology
in 2018 and has served as Vice President of Finance since September
2022. He has 14 years of finance and accounting experience and has
been instrumental in the Company’s strategic transformation. Prior
to joining Verastem, he was a Technical Accounting Consultant at
CFGI where he advised companies across a variety of industries on
technical accounting issues, financial statement preparation and
initial public offering readiness, and internal controls. Mr.
Calkins began his career at PwC, LLP in Boston within the Assurance
practice. He received his Bachelor of Science in Accounting from
Bryant University and his Master of Science in Accounting from
Northeastern University.
About the Avutometinib and Defactinib Combination
Avutometinib is a RAF/MEK clamp that induces inactive complexes
of MEK with ARAF, BRAF and CRAF potentially creating a more
complete and durable anti-tumor response through maximal RAS
pathway inhibition. In contrast to currently available MEK
inhibitors, avutometinib blocks both MEK kinase activity and the
ability of RAF to phosphorylate MEK. This unique mechanism allows
avutometinib to block MEK signaling without the compensatory
activation of MEK that appears to limit the efficacy of other
inhibitors. The U.S. Food and Drug Administration granted
Breakthrough Therapy designation for the combination of Verastem
Oncology’s investigational RAF/MEK clamp avutometinib, with
defactinib, its FAK inhibitor, for the treatment of all patients
with recurrent low-grade serous ovarian cancer (LGSOC) regardless
of KRAS status after one or more prior lines of therapy, including
platinum-based chemotherapy.
Verastem Oncology is currently conducting clinical trials with
its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part
of its (Raf And Mek Program). RAMP 301
is a Phase 3 confirmatory trial evaluating the combination of
avutometinib and defactinib versus standard chemotherapy or
hormonal therapy for the treatment of recurrent LGSOC. RAMP 201 is
a Phase 2 registration-directed trial of avutometinib in
combination with defactinib in patients with recurrent LGSOC and
has completed enrollment in the dose optimization and expansion
phases and is enrolling for low-dose evaluation. Verastem Oncology
has established clinical collaborations with Amgen and Mirati to
evaluate LUMAKRAS™ (sotorasib) and KRAZATI™ (adagrasib) in
combination with avutometinib in KRAS G12C mutant NSCLC as part of
the RAMP 203 and RAMP 204 trials, respectively. Supported by the
“Therapeutic Accelerator Award” Verastem Oncology received from
PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical
trial evaluating avutometinib and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with cancer. Our pipeline is focused on novel small
molecule drugs that inhibit critical signaling pathways in cancer
that promote cancer cell survival and tumor growth, including
RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For
more information, please visit www.verastem.com.
Forward-Looking Statements Notice
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements related to the potential clinical value of various of
its clinical trials, anticipated regulatory filings and
commercialization expectations and timing. The words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," “can,” “promising” 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 and
uncertainties, among other things, regarding: the success in the
development and potential commercialization of our product
candidates, including avutometinib in combination with other
compounds, including defactinib, LUMAKRASTM and others; the
occurrence of adverse safety events and/or unexpected concerns that
may arise from additional data or analysis or result in
unmanageable safety profiles as compared to their levels of
efficacy; our ability to obtain, maintain and enforce patent and
other intellectual property protection for our product candidates;
the scope, timing, and outcome of any legal proceedings; decisions
by regulatory authorities regarding trial design, labeling and
other matters that could affect the timing, availability or
commercial potential of our product candidates; whether preclinical
testing of our product candidates and preliminary or interim data
from clinical trials will be predictive of the results or success
of ongoing or later clinical trials; that the timing, scope and
rate of reimbursement for our product candidates is uncertain; that
third-party payors (including government agencies) may not
reimburse; that there may be competitive developments affecting our
product candidates; that data may not be available when expected;
that we may not attract and retain high quality personnel; that
enrollment of clinical trials may take longer than expected; that
our product candidates will experience manufacturing or supply
interruptions or failures; that we will be unable to successfully
initiate or complete the clinical development and eventual
commercialization of our product candidates; that the development
and commercialization of our product candidates will take longer or
cost more than planned, including as a result of conducting
additional studies; that our target market for our product
candidates might be smaller than we are presently estimating; that
we or Chugai Pharmaceutical Co., Ltd. will fail to fully perform
under the avutometinib license agreement; that we or our other
collaboration partners may fail to perform under our collaboration
agreements; that any of our third-party contract research
organizations, contract manufacturing organizations, clinical
sites, or contractors, among others, who we rely on fail to fully
perform; that we may not have sufficient cash to fund our
contemplated operations; that we may be unable to obtain adequate
financing in the future through product licensing, co-promotional
arrangements, public or private equity, debt financing or
otherwise; that Secura Bio, Inc. will achieve the milestones that
result in payments to us under our asset purchase agreement with
Secura Bio, Inc.; that we will be unable to execute on our
partnering strategies for avutometinib in combination with other
compounds; that we will not pursue or submit regulatory filings for
our product candidates; and that our product candidates will not
receive regulatory approval, become commercially successful
products, or result in new treatment options being offered to
patients.
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, 2022 as filed with the Securities
and Exchange Commission (SEC) on March 14, 2023 and in any
subsequent filings with the SEC. The forward-looking statements
contained in this press release reflect Verastem Oncology’s views
as of the date hereof, and Verastem Oncology does not assume and
specifically disclaims any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231026794275/en/
Media: Lisa Buffington Corporate Communications +1
781-292-4502 lbuffington@verastem.com
Investors: Ryan Porter Argot Partners +1 212-600-1902
ryan.porter@argotpartners.com
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