Verastem, Inc. (NASDAQ:VSTM), focused on discovering and
developing drugs to improve the survival and quality of life of
cancer patients, today announced payment of a $6 million milestone
to Infinity Pharmaceuticals, Inc., representing the first milestone
under the duvelisib license agreement between Verastem and
Infinity. This milestone is based on the achievement of positive
top-line results from the Phase 3 DUO™ study evaluating the
efficacy and safety of duvelisib in patients with relapsed or
refractory chronic lymphocytic leukemia (CLL)/small lymphocytic
lymphoma (SLL).
In addition, Verastem drew an additional advance of $7.5 million
from its existing $25 million loan and security agreement, dated
March 21 2017, with Hercules Capital, Inc. (the Term Loan
Facility). The proceeds will be used to pay the $6 million
milestone payment to Infinity, for ongoing research and development
programs, and for general corporate purposes. Verastem has drawn a
total of $10 million under the Term Loan Facility, leaving $15
million in available additional advances, subject to certain
conditions of funding.
“Payment of this milestone to Infinity reflects the attainment
of a critical milestone for the duvelisib development program,
positive data from the Phase 3 DUO study in CLL/SLL,” said Julie B.
Feder, Chief Financial Officer of Verastem. “We have elected to
employ the non-dilutive option of drawing a second tranche of
funding under our Term Loan Facility. We believe this approach is a
prudent use of the strategic financial tools that we have at hand
as we advance the program towards a potential NDA filing in H1
2018.”
In September 2017, Verastem reported that the Phase 3 DUO study
met its primary endpoint with oral duvelisib monotherapy
demonstrating superiority over ofatumumab for progression free
survival (PFS) in patients with CLL/SLL. In this study, duvelisib
achieved a statistically significant improvement in median PFS of
13.3 months, compared to 9.9 months for ofatumumab with a hazard
ratio (HR) of 0.52 (p<0.0001), representing a 48% reduction in
the risk of progression or death. Verastem plans to share these
clinical data with the U.S. Food and Drug Administration (FDA)
during Q4 2017 with the goal of filing a New Drug Application (NDA)
with the FDA during the first half of 2018. The duvelisib NDA
submission will also be supported by favorable results from the
Phase 2 DYNAMO™ study in indolent non-Hodgkin’s lymphoma (iNHL),
which also achieved its primary endpoint with an ORR of 46%
(p<0.0001).
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 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
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version on businesswire.com: http://www.businesswire.com/news/home/20171017005462/en/
Verastem, Inc.Brian Sullivan, 781-292-4214Director,
Corporate Developmentbsullivan@verastem.com
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