Hagop Youssoufian, MSc, MD Named Head of
Hematology and Oncology Development; Greg I. Berk, MD to Transition
to Senior Advisor and Member of Clinical and Scientific Advisory
Board
Lori Kunkel, MD and Edmund J. Pezalla, MD, MPH
Appointed to Clinical and Scientific Advisory Board
Michael Ferraresso to Join the Company as Vice
President, Commercial Operations
Verastem, Inc. (NASDAQ: VSTM), focused on discovering and
developing drugs to treat cancer, today announced that Hagop
Youssoufian, MSc, MD, has been appointed Head of Hematology and
Oncology Development. In this role, Dr. Youssoufian will oversee
the clinical and regulatory development of the Company’s pipeline,
including duvelisib, an investigational product candidate currently
in development for hematologic malignancies, and provide overall
strategic and tactical leadership to Verastem's hematology-oncology
clinical programs. Dr. Youssoufian brings over 25 years of product
development and commercialization experience to Verastem. In
addition, Lori Kunkel, MD, and Edmund J. Pezalla, MD, MPH, have
been appointed to the Clinical and Scientific Advisory Board
(CSAB), and Michael Ferraresso will join the Company as Vice
President, Commercial Operations. Greg I. Berk, MD, will transition
to the role of Senior Advisor from Chief Medical Officer and will
join the CSAB.
“We welcome Hagop to the Verastem team to lead the late-stage
development of duvelisib in lymphoid malignancies,” said Robert
Forrester, President and Chief Executive Officer of Verastem. “Both
Hagop and Lori are highly regarded leaders in oncology drug
development who bring to Verastem deep experience in developing
successful clinical and regulatory strategies that result in
globally approved novel oncology therapies. In addition, we are now
in early commercial planning and are selectively building out the
team to potentially launch duvelisib following the readout of the
Phase 3 DUO study in CLL. To help make this a reality, we welcome
Mike from Infinity Pharmaceuticals where he was involved in the
commercial strategy for duvelisib. Ed is a leading innovator in
payer strategy and has extensive relationships with a variety of
policy and industry groups. These individuals have an impressive
track record of unlocking the value of new products that we believe
will prove invaluable as we pursue future market opportunities. We
believe these appointments are key additions to the Verastem
leadership team and represent our commitment to advancing our lead
assets, duvelisib and defactinib, through several key clinical and
regulatory milestones in the coming quarters. We thank Greg for his
tenure as Chief Medical Officer and look forward to his continued
contributions as Senior Advisor and as a member of the CSAB.”
Prior to joining Verastem, Dr. Youssoufian served most recently
as Chief Medical Officer at BIND Therapeutics. Prior to BIND, he
was Executive Vice President at Progenics Pharmaceuticals and
President, Research & Development and Chief Medical Officer at
Ziopharm Oncology. Before joining Ziopharm, Dr. Youssoufian served
as Chief Medical Officer and Senior Vice President, Global Clinical
Sciences at Imclone Systems. Prior to Imclone, he served in
leadership positions at Sanofi Aventis and Bristol-Myers Squibb.
During his career in industry, Dr. Youssoufian was involved in the
development and approval of several oncology treatments, including
Sprycel®, Taxotere® and Erbitux®. Dr. Youssoufian graduated from
Boston College (BS, Magna Cum Laude) and the University of
Massachusetts Medical School (MSc, MD). After training in Internal
Medicine at Cleveland Clinic and Johns Hopkins, he completed
fellowships in Clinical Genetics at Johns Hopkins and in
Hematology-Oncology at Massachusetts General Hospital, and was a
Visiting Scientist at Whitehead Institute, MIT. He then served on
the faculties of Harvard Medical School as Assistant Professor of
Medicine and at Baylor College of Medicine as Associate Professor
and Division Chief of Medical Genetics.
Dr. Kunkel has more than two decades of experience in oncology
and immunology drug development and commercialization. Dr. Kunkel
presently serves on the Board of Directors of Loxo Oncology, where
she was previously the acting Chief Medical Officer. Prior to Loxo,
she served as Chief Medical Officer at Pharmacyclics (acquired by
AbbVie) and Proteolix, Inc. (acquired by Onyx Pharmaceuticals),
where she contributed to the global approvals of cancer
therapeutics IMBRUVICA® and Kyprolis®, respectively. Prior to that,
she served as Vice President of Clinical Development at Xencor,
Inc. Before these executive leadership positions, Dr. Kunkel was a
clinical scientist at Genentech where she worked on the development
of RITUXAN®. Additionally, as a clinical drug development
specialist, she has advised multiple clients including Chiron
(acquired by Novartis), Genentech/Roche, Salmedics (acquired by
Celgene), Stemcentrx, Inc. and Amphivena Therapeutics, and she
serves on the Board of Directors of Curis, Inc., Tocagen and
Maverick Therapeutics. Prior to joining the biotechnology industry,
Dr. Kunkel spent ten years in academic medicine and served as a
faculty member at the Bone Marrow Transplant Unit in the Division
of Hematology/Oncology at University of California, Los Angeles.
Dr. Kunkel obtained a medical degree from University of Southern
California and a bachelor's degree in biology from University of
California, San Diego. She is board certified in internal medicine
and held board certifications in hematology and oncology.
Dr. Pezalla is active as a payer expert on a number of policy
working groups including the New Drug Development Paradigm Project
at MIT. He is the former Vice President for Pharmaceutical Policy
and Strategy in the Office of the Chief Medical Officer at Aetna.
In this position Dr. Pezalla developed and coordinated strategy for
pharmaceutical evaluation and coverage across both the medical and
pharmacy benefit, created Aetna’s framework for innovative
contracts, and developed Aetna’s public policy positions on drug
and device coverage. Dr. Pezalla is a member of the Board of
Directors of the Pharmacy Quality Alliance and the Connecticut
Biosciences Innovation Fund. He is also a member of the Business
Advisory Board of Naia Pharmaceuticals and the Scientific Advisory
Board of Temple Therapeutics. He was recently named a
Scholar-in-Residence at the Duke-Margolis Health Policy Center in
Washington, DC where he is working on policy approaches to
stimulating the development of new antimicrobials, evaluation of
value frameworks, and other policy projects. Dr. Pezalla received
his BS in Biophysics from Georgetown University College of Arts and
Sciences, and his MD Cum Laude from Georgetown University School of
Medicine. He holds a Masters in Public Health from the University
of California at Berkeley and was a health services research fellow
and doctoral student in health policy at the University of
Michigan.
Prior to joining Verastem, Mr. Ferraresso served as Vice
President, Commercial at Infinity Pharmaceuticals where he was
instrumental in designing the commercial strategy for duvelisib and
chaired the joint commercial committee for the partnership. From
1998-2013, he served in sales and commercial operations roles of
increasing responsibility at several biotechnology and
pharmaceutical companies, including AVEO Pharmaceuticals, AMAG
Pharmaceuticals, Critical Therapeutics, Praecis Pharmaceuticals,
Ascent Pediatrics and Muro Pharmaceuticals. Mr. Ferraresso has
extensive experience in commercial strategy including partnerships,
development, pricing and field deployment models and has launched
Oprapred™, Plenaxis™, Zyflo™ and Feraheme™. Mr. Ferraresso holds a
BA degree in Economics from Assumption College.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of
phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes
that are 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/refractory chronic lymphocytic
leukemia (CLL),4 and DYNAMO®, a single-arm, Phase 2 monotherapy
study in patients with refractory indolent non-Hodgkin lymphoma
(iNHL) that achieved its primary endpoint of overall response rate
upon topline analysis of efficacy data.5 Duvelisib is also being
evaluated for the treatment of hematologic malignancies through
investigator-sponsored studies, including T cell lymphoma.6
Information about duvelisib clinical trials can be found on
www.clinicaltrials.gov.
About Defactinib
Defactinib (VS-6063) is an investigational inhibitor of Focal
Adhesion Kinase (FAK), a non-receptor tyrosine kinase encoded by
the PTK-2 gene 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 phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma, which has successfully met its primary endpoint in a
Phase 2 study and is currently being evaluated in a Phase 3
clinical trial in patients with chronic lymphocytic leukemia (CLL).
Other clinical product candidates include focal adhesion kinase
(FAK) inhibitors defactinib (VS-6063) and VS-4718, and dual
PI3K/mTOR inhibitor VS-5584. 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 and 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 Verastem’s PI3K/mTOR and FAK programs
generally, the structure of our planned and pending clinical trials
and the timeline and indications for clinical development,
including reporting top-line data, and regulatory submissions and,
our rights to develop or commercialize our product candidates. 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 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 data may not be available when expected, including for
the Phase 3 DUO study; 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 will
fail to fully perform under the license agreement; that the
transition of the duvelisib program from Infinity will not be
completed; that Verastem will not pursue or submit regulatory
filings for its product candidates, including for duvelisib in
patients with CLL or iNHL; 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, 2015 as filed
on March 3, 2016, the Company’s quarterly report on Form 10-Q filed
on November 7, 2016, and in any subsequent SEC filings. The
forward-looking statements contained in this press release reflect
Verastem’s current views as of the date of this release with
respect to future events, and Verastem does not undertake and
specifically disclaims any obligation to update any forward-looking
statements.
References
1 Winkler D.G., Faia K.L., DiNitto J.P. 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 K 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 M 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
7Schaller MD and Parsons JT. Focal adhesion kinase: an
integrin-linked protein tyrosine kinase. Trends Cell Biol. 1993 3:
258-62.
8Jiang H et al. Targeting focal adhesion kinase renders
pancreatic cancers responsive to checkpoint immunotherapy. Nat Med
2016: Aug 22(8) 851-60.
9Sulzmaier FJ 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
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version on businesswire.com: http://www.businesswire.com/news/home/20170119006236/en/
Verastem, Inc.Brian Sullivan, 781-292-4214Director,
Corporate Developmentbsullivan@verastem.com
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