Appointment Reflects Progress of Verastem’s RAS
Targeted Therapy Development Program
Verastem Recently Initiated
Registration-Directed Trials with VS-6766 and Defactinib in
Recurrent Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small
Cell Lung Cancer
Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology),
a biopharmaceutical company committed to advancing new medicines
for patients battling cancer, today announced the appointment of
industry veteran Frank Neumann, M.D., Ph.D., as Chief Medical
Officer to oversee the Company’s clinical and regulatory strategy
and Medical Affairs team.
“Frank brings deep expertise across the full spectrum of
clinical and regulatory activities in all stages of Oncology drug
development,” said Brian Stuglik, Chief Executive Officer of
Verastem Oncology. “His strong industry experience and commitment
to urgently addressing the high unmet needs of patients will be
critical to delivering novel treatments and establishing the
backbone of RAS targeted therapy as we move forward with our
registration-directed trials of VS-6766 and defactinib.”
“I am thrilled to be joining Verastem at this time given the
encouraging results to date of VS-6766 and defactinib for patients
with difficult-to-treat KRAS mutant tumors and the possibility to
address limitations seen with other therapeutic approaches,” said
Dr. Neumann. “The broad potential of these development programs and
the opportunity to further establish Verastem’s scientific and
medical leadership is truly energizing.”
Dr. Neumann joins Verastem from bluebird bio where he served as
VP, Head of Oncology Clinical Research, Clinical Research
Development. In this role, he was responsible for planning and
execution of oncology research asset strategies from pre-clinical
to Investigational New Drug Application (IND) submissions, across
both solid tumor and hematological indications. He has also held
various leadership roles at Takeda Pharmaceuticals, including
global clinical lead for ICLUSIG® (ponatinib) and medical team lead
for NINLARO® (ixazomib). He served as clinical development head for
all of Takeda’s cell therapy approaches globally from POC to Phase
1 and was also responsible for various U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA)
interactions for Takeda’s programs.
Earlier in his career, Dr. Neumann was a member of the oncology
medical teams at AstraZeneca and Sanofi-Aventis and was a research
scholar at the University of Texas MD Anderson Cancer Center. Dr.
Neumann received his medical degree from the Heinrich-Heine
University in Duesseldorf, Germany and his Ph.D. from the
Rheinische-Friedrich-Wilhelm University in Bonn, Germany. He is
Board-Certified in Hematology/Oncology, Internal Medicine, and
Palliative Care Medicine and is currently an assistant professor at
the Heinrich Heine University in Düsseldorf, Germany.
About VS-6766
VS-6766 is an oral small molecule inhibitor of the RAF/MEK
signaling pathway. In contrast to other MEK inhibitors in
development, VS-6766 blocks both MEK kinase activity and the
ability of RAF to phosphorylate MEK. This unique mechanism allows
VS-6766 to block MEK signaling without the compensatory activation
of MEK that appears to limit the efficacy of other inhibitors.
About Defactinib
Defactinib (VS-6063) is an oral small molecule inhibitor of the
FAK and PYK2 signaling pathways that is currently being evaluated
as a potential combination therapy for various solid tumors.
Verastem has received Orphan Drug Designation for defactinib in
ovarian cancer in the U.S., EU and Australia. Preclinical research
by Verastem Oncology scientists and collaborators at world-renowned
research institutions have described the effect of FAK inhibition
to enhance immune response by decreasing immuno-suppressive cells,
increasing cytotoxic T cells, and reducing stromal density, which
allows tumor-killing immune cells to enter the tumor.1,2
About the VS-6766/Defactinib Combination
RAS mutant tumors are present in about 30% of all human cancers,
have historically presented a difficult treatment challenge and are
often associated with significantly worse prognosis.3 Challenges
associated with identifying new treatment options for these types
of cancers include resistance to single agents,3 identifying
tolerable combination regimens with MEK inhibitors and new RAS
inhibitors in development addressing only a minority of all RAS
mutated cancers.
The combination of VS-6766 and defactinib has been found to be
clinically active in patients with KRAS mutant tumors. In an
ongoing investigator-initiated Phase 1/2 FRAME study, the
combination of VS-6766 and defactinib is being evaluated in
patients with recurrent low-grade serous ovarian cancer (LGSOC),
KRAS mutant NSCLC and colorectal cancer. Updated data from this
study presented at the 2nd Annual RAS-Targeted Drug Development
Summit in September 2020 demonstrated a 56% overall response rate
and long duration of therapy among patients with KRAS-G12 mutant
LGSOC.4 Based on an observation of higher response rates seen in
NSCLC patients with KRAS-G12V mutations in the study, Verastem is
also exploring the role of VS-6766 and defactinib in KRAS-G12V
mutant NSCLC. The FRAME study was expanded in August 2020 to
include new cohorts in pancreatic cancer, KRAS mutant endometrial
cancer and KRAS-G12V mutant NSCLC.
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’s strategy, future plans and prospects, including
statements related to the potential clinical value of the
RAF/MEK/FAK combination. 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 defactinib in combination with VS-6766; 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 labeling and other matters that
could affect the 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 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; that we or Chugai Pharmaceutical Co., Ltd. will fail to
fully perform under the VS-6766 license agreement; that we may not
have sufficient cash to fund our contemplated operations; that we
may be unable to make additional draws under our debt facility or
obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will be unable to execute on our
partnering strategies for defactinib in combination with VS-6766;
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 our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020 as filed with the Securities and
Exchange Commission (SEC) on November 9, 2020 and in any subsequent
filings with the SEC. The forward-looking statements contained in
this press release reflect Verastem’s views as of the date hereof,
and we do not assume and specifically disclaim any obligation to
update any forward-looking statements whether as a result of new
information, future events or otherwise, except as required by
law.
References
1 Chénard-Poirier, M. et al. Results from the biomarker-driven
basket trial of RO5126766 (CH5127566), a potent RAF/MEK inhibitor,
in RAS- or RAF-mutated malignancies including multiple myeloma.
Journal of Clinical Oncology 2017: 35.
10.1200/JCO.2017.35.15_suppl.2506. 2 ClinicalTrials.gov. Phase I
Trial of VS-6063 and RO5126766. (FRAME). Available at:
https://clinicaltrials.gov/ct2/show/NCT03875820. Accessed November
24, 2020. 3 Baines, A. T., Xu, D., & Der, C. J. (2011).
Inhibition of Ras for cancer treatment: the search continues.
Future medicinal chemistry, 3(14), 1787–1808.
https://doi.org/10.4155/fmc.11.121 4 Verastem Press Release.
Verastem Oncology Announces Presentation of Updated Phase 1/2 FRAME
Study Data at the 2nd Annual RAS-Targeted Drug Development Summit.
September 16, 2020. Available at:
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-presentation-updated-phase-12-frame.
Accessed November 24, 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20210106005499/en/
Investors: Ajay Munshi Vice President, Corporate Development 1
781-469-1579 amunshi@verastem.com
Media: Lisa Buffington Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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