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
BOSTON--(BUSINESS WIRE)--Jan. 19, 2017--
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170119006236/en/
Source: Verastem, Inc.
Verastem, Inc.
Brian Sullivan, 781-292-4214
Director,
Corporate Development
bsullivan@verastem.com