Verastem, Inc. (NASDAQ:VSTM), focused on discovering and
developing drugs to improve the survival and quality of life of
cancer patients, today announced the appointment of NgocDiep Le,
MD, PhD, as Chief Medical Officer. Dr. Le will be responsible for
overseeing the development strategy and activities for Verastem’s
core assets, duvelisib and defactinib.
“Diep is a highly accomplished physician-scientist who possesses
exceptional scientific, medical, and organizational skills, with a
unique background that includes a dual focus on hematologic
oncology and immuno-oncology,” said Robert Forrester, President and
Chief Executive Officer of Verastem. “She also brings extensive
experience forging relationships with key opinion leaders and
designing and executing successful clinical development programs.
We are delighted to welcome Diep to the Verastem team and believe
her contributions will be invaluable as we work toward our goal of
filing a New Drug Application (NDA) for duvelisib with the U.S.
Food and Drug Administration (FDA) during the first half of
2018.”
Dr. Le commented, “Given my previous work on phosphoinositide
3-kinase (PI3K) and focal adhesion kinase (FAK) inhibitors at
GlaxoSmithKline (GSK), I have been following the development of
duvelisib and defactinib for some time, and I am excited by each
asset’s potential for new treatment options for patients with
cancer. With the recently reported top-line results from the Phase
3 DUO study in chronic lymphocytic leukemia (CLL)/small lymphocytic
lymphoma (SLL), Verastem has created positive momentum with
duvelisib, and I look forward to leveraging this with key opinion
leaders and other stakeholders as we work to prepare and file the
duvelisib NDA. For defactinib, I will be working with the entire
team to ensure its rapid advancement in combination with
immunotherapies and other anti-cancer agents for the treatment of a
broad range of solid tumors.”
A trained medical oncologist, Dr. Le is board certified in
internal medicine and has 15 years of drug development experience
across all phases in both solid and liquid tumors, with specialized
expertise in clinical development, medical affairs and clinical
operations. Dr. Le joins Verastem from MedImmune (a wholly owned
subsidiary of AstraZeneca) where she served as Vice President,
Immuno-Oncology Innovative Medicines and led the product
development teams for multiple high-priority immuno-oncology
assets. Prior to MedImmune, Dr. Le served as Global Clinical
Program Head and Executive Medical Director at Novartis Oncology
where she designed and implemented the development strategy for
multiple oncology assets in late-stage clinical evaluation. Prior
to working at Novartis, she served as Senior/Executive Medical
Director at GSK, Oncology Research & Development, where she
successfully led the clinical development program for the MEK
inhibitor, trametinib, from first-in-human studies through to FDA
approval in 2013 and was also integral in the development of both
PI3K and FAK inhibitors. Dr. Le began her industry career at Amgen,
Inc. as Medical Sciences Medical Director, Early Development
Oncology, where she led multidisciplinary teams to bring late-stage
research products through IND filing and Phase 1 proof-of-concept
studies to position drugs for the late phase development. Dr. Le
received her B.S. in Biology from the California Institute of
Technology, earned her MD and PhD from Stanford University School
of Medicine, and trained in internal medicine and oncology at
Stanford University Medical Center. She also completed a Clinical
Fellowship in Hematology/Oncology at the Duke Comprehensive Cancer
Center at Duke University and was promoted to a faculty member in
the Divisions of Medical Oncology and Cellular Therapy/Bone Marrow
Transplantation prior to the completion of her fellowship.
Equity Awards
In connection with the hiring of Dr. Le, effective October 9,
2017, Verastem granted to Dr. Le a stock option to purchase 150,000
shares of Verastem’s common stock under its 2012 Incentive Plan, as
well as a stock option to purchase 150,000 shares of Verastem's
common stock pursuant to the NASDAQ inducement grant exception as a
component of Dr. Le’s employment compensation. The stock option to
purchase 150,000 shares of Verastem’s common stock was granted as
an inducement material to her acceptance of employment with
Verastem in accordance with NASDAQ Listing Rule 5635(c)(4). Both
options have an exercise price equal to $4.63, the closing price of
Verastem's common stock as reported by NASDAQ on October 9, 2017,
and will vest as to 25% of the shares subject to the option on the
first anniversary of the date of hire and as to an additional 6.25%
of the shares subject to the option at the end of each successive
three-month period following the first anniversary of the date of
hire, provided that Dr. Le continues to serve as an employee of or
other service provider to Verastem on each such vesting date. Dr.
Le was also granted a performance-based stock option to purchase
70,000 shares of Verastem’s common stock under its 2012 Incentive
Plan. The performance-based option will vest in full on the date on
which Verastem receives notice of approval by the FDA of the NDA
for duvelisib, provided that Dr. Le continues to serve as an
employee of or other service provider to Verastem on the vesting
date.
Verastem also granted on September 25, 2017 stock options to two
new employees to purchase an aggregate of 71,500 shares of
Verastem’s common stock. The options were granted pursuant to the
NASDAQ inducement grant exception as a component of the employees
entering into employment with Verastem and were granted as an
inducement material to their acceptance of employment with Verastem
in accordance with NASDAQ Listing Rule 5635(c)(4). The options have
an exercise price equal to $4.82, the closing price of Verastem's
common stock as reported by NASDAQ on September 25, 2017. The
awards will vest as to 25% of the shares subject to the options on
the first anniversary of the date of hire and as to an additional
6.25% of the shares subject to the options at the end of each
successive three-month period following the first anniversary of
the date of hire, provided that the employees continue to serve as
an employee of or other service provider to Verastem on each such
vesting date.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of
phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes
known to help support the growth and survival of malignant B-cells
and T-cells. PI3K signaling may lead to the proliferation of
malignant B-cells and is thought to play a role in the formation
and maintenance of the supportive tumor microenvironment.1,2,3
Duvelisib is currently being evaluated in late- and mid-stage
clinical trials, including DUO™, a randomized, Phase 3 monotherapy
study in patients with relapsed or refractory CLL/SLL,4 and
DYNAMO™, a single-arm, Phase 2 monotherapy study in patients with
refractory iNHL that achieved its primary endpoint of ORR.5
Duvelisib is also being evaluated for the treatment of other
hematologic malignancies, including T-cell lymphoma, through
investigator-sponsored studies.6 Information about duvelisib
clinical trials can be found on www.clinicaltrials.gov.
About Defactinib
Defactinib (VS-6063) is an investigational inhibitor of FAK, a
non-receptor tyrosine kinase that mediates oncogenic signaling in
response to cellular adhesion and growth factors.7 Based on the
multi-faceted roles of FAK, defactinib is used to treat cancer
through modulation of the tumor microenvironment, enhancement of
anti-tumor immunity, and reduction of cancer stem cells.8,9
Defactinib is currently being evaluated in three separate clinical
collaborations in combination with immunotherapeutic agents for the
treatment of several different cancer types including pancreatic,
ovarian, non-small cell lung cancer, and mesothelioma. These
studies are combination clinical trials with pembrolizumab and
avelumab from Merck & Co. and Pfizer/Merck KGaA,
respectively.10,11,12 Information about these and additional
clinical trials evaluating the safety and efficacy of defactinib
can be found on www.clinicaltrials.gov.
About Verastem, Inc.
Verastem, Inc. (NASDAQ:VSTM) is a biopharmaceutical company
focused on discovering and developing drugs to improve outcomes for
patients with cancer. Verastem is currently developing duvelisib, a
dual inhibitor of PI3K-delta and PI3K-gamma, which has successfully
met its primary endpoint in a Phase 2 study in iNHL and a Phase 3
clinical trial in patients with CLL/SLL. In addition, Verastem is
developing the FAK inhibitor defactinib, which is currently being
evaluated in three separate clinical collaborations in combination
with immunotherapeutic agents for the treatment of several
different cancer types, including pancreatic cancer, ovarian
cancer, non-small cell lung cancer, and mesothelioma. Verastem’s
product candidates seek to treat cancer by modulating the local
tumor microenvironment, enhancing anti-tumor immunity, and reducing
cancer stem cells. For more information, please visit
www.verastem.com.
Verastem, Inc. forward-looking statements notice:
This press release includes forward-looking statements about
Verastem's strategy, future plans and prospects, including
statements regarding the development and activity of Verastem's
investigational product candidates, including duvelisib and
defactinib, and Verastem's PI3K and FAK programs generally, the
structure of our planned and pending clinical trials and the
timeline and indications for clinical development. The words
"anticipate," "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 full data from the DUO
study will not be consistent with the top-line results of the
study; that the preclinical testing of Verastem'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 even if data from clinical trials is
positive, regulatory authorities may require additional studies for
approval and the product may not prove to be safe and effective;
that the degree of market acceptance of product candidates, if
approved, may be lower than expected; that the timing, scope and
rate of reimbursement for our product candidates is uncertain; 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 cause unexpected safety events or
result in an unmanageable safety profile as compared to their level
of efficacy; that duvelisib will be ineffective at treating
patients with lymphoid malignancies; that Verastem will be unable
to successfully initiate or complete the clinical development of
its product candidates; that the development of Verastem's product
candidates will take longer or cost more than planned; that
Verastem may not have sufficient cash to fund its contemplated
operations; that Verastem or Infinity Pharmaceuticals, Inc. will
fail to fully perform under the duvelisib license agreement; that
Verastem will not pursue or submit regulatory filings for its
product candidates; and that Verastem's 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 Verastem's Annual Report on
Form 10-K for the year ended December 31, 2016 and in any
subsequent filings with the U.S. Securities and Exchange
Commission. The forward-looking statements contained in this press
release reflect Verastem's views as of the date of this release,
and Verastem does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
References
1 Winkler et al. PI3K-delta and PI3K-gamma inhibition by IPI-145
abrogates immune responses and suppresses activity in autoimmune
and inflammatory disease models. Chem Biol 2013; 20:1-11.
2 Reif et al. Cutting Edge: Differential roles for
phosphoinositide 3 kinases, p110-gamma and p110-delta, in
lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
3 Schmid et al. Receptor tyrosine kinases and TLR/IL1Rs
unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell
2011;19:715-727.
4 www.clinicaltrials.gov, NCT02004522
5 www.clinicaltrials.gov, NCT01882803
6 www.clinicaltrials.gov, NCT02783625, NCT02783625,
NCT02158091
7 Schaller M.D. and Parsons J.T. Focal adhesion kinase: an
integrin-linked protein tyrosine kinase. Trends Cell Biol. 1993 3:
258-62.
8 Jiang H et al. Targeting focal adhesion kinase renders
pancreatic cancers responsive to checkpoint immunotherapy. Nat Med
2016: Aug 22(8) 851-60.
9 Sulzmaier F.J. et al. FAK in cancer: mechanistic findings and
clinical applications. Nature Rev Cancer. 2014 14: 598-610.
10 www.clinicaltrials.gov, NCT02546531
11 www.clinicaltrials.gov, NCT02943317
12 www.clinicaltrials.gov, NCT02758587
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version on businesswire.com: http://www.businesswire.com/news/home/20171011006225/en/
Verastem, Inc.Brian Sullivan, 781-292-4214Director,
Corporate Developmentbsullivan@verastem.com
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