Verastem, Inc. (NASDAQ:VSTM), focused on discovering and
developing drugs to treat cancer, today announced that new data for
duvelisib, an investigational, oral, dual inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be
presented at the American Society of Hematology (ASH) 2016 Annual
Meeting, being held December 3-6, 2016 in San Diego.
Data from DYNAMO®, a Phase 2 monotherapy study evaluating the
efficacy and safety of duvelisib in relapsed/refractory iNHL, will
be presented in an oral session. Updated data from CONTEMPO, a
Phase 1b/2 study evaluating duvelisib in combination with rituximab
or obinutuzmab in treatment-naïve follicular lymphoma patients, and
preclinical research on the role of Focal Adhesion Kinase (FAK)
inhibition in AML, will be presented in a poster session.
Details for the presentations at ASH are below:
Oral Presentation
Title: DYNAMO: A phase 2 study demonstrating the clinical
activity of duvelisib in patients with relapsed refractory indolent
non-Hodgkin lymphomaLead Author: Ian Flinn, M.D., Ph.D.,
Director, Hematologic Malignancies Program, Sarah Cannon Research
InstituteAbstract Number: 1218Location: San Diego
Convention Center, Ballroom 20BCDate and Time: Monday,
December 5, 2016, 7:30 – 7:45 pm PT
The full abstract can be viewed here.
Poster Presentations
Title: Preliminary results in first-line treatment of
follicular lymphoma with the oral dual PI3K-delta,gamma inhibitor,
duvelisib, in combination with rituximab or obinutuzumabLead
Author: Carla Casulo, M.D., Assistant Professor, Wilmot Cancer
Institute, University of RochesterAbstract Number:
2979Location: San Diego Convention Center, Hall GHDate
and Time: Sunday, December 4, 2016, 6:00 - 8:00 pm PT
The full abstract can be viewed here.
Title: Inhibition of FAK Exerts Anti-Leukemic Activity
and Potentiates ABT-199-Induced Apoptosis in AMLLead Author:
Bing Carter, Ph.D.., Associate Professor, Department of Leukemia -
Research, Division of Cancer Medicine, The University of Texas MD
Anderson Cancer CenterAbstract Number: 1574Location:
San Diego Convention Center, Hall GHDate and Time: Saturday,
December 3, 2016, 5:30 – 7:30 pm PT
The full abstract can be viewed here.
About the Tumor Microenvironment
The tumor microenvironment encompasses various cellular
populations and extracellular matrices within the tumor or cancer
niche that support cancer cell survival. This includes
immunosuppressive cell populations such as regulatory T cells,
myeloid-derived suppressor cells, M2 tumor-associated macrophages,
as well as tumor-associated fibroblasts and extracellular matrix
proteins which can hamper the entry and therapeutic benefit of
cytotoxic immune cells and anti-cancer drugs. In addition to
targeting the proliferative and survival signaling of cancer cells,
Verastem’s compounds duvelisib, defactinib, VS-4718 and VS-5584
also target the tumor microenvironment as a mechanism of action to
potentially improve a patient’s response to therapy.
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 data5. 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 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 VS-6063 and VS-4718, and dual PI3K/mTOR inhibitor
VS-5584. VS-6063 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 the development and activity of Verastem’s
product candidate duvelisib, and Verastem’s PI3K/mTOR program
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 and in any
subsequent SEC filings. The forward-looking statements contained in
this press release reflect Verastem’s current views 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
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version on businesswire.com: http://www.businesswire.com/news/home/20161103005926/en/
Verastem, Inc.Brian SullivanDirector, Corporate
Development781-292-4214bsullivan@verastem.com
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