BOSTON--(BUSINESS WIRE)--Oct. 11, 2017--
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.
10www.clinicaltrials.gov,
NCT02546531
11www.clinicaltrials.gov,
NCT02943317
12www.clinicaltrials.gov,
NCT02758587
View source version on businesswire.com: http://www.businesswire.com/news/home/20171011006225/en/
Source: Verastem, Inc.
Verastem, Inc.
Brian Sullivan, 781-292-4214
Director,
Corporate Development
bsullivan@verastem.com