BOSTON, Mass.--(BUSINESS WIRE)--Oct. 17, 2017--
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20171017005462/en/
Source: Verastem, Inc.
Verastem, Inc.
Brian Sullivan, 781-292-4214
Director,
Corporate Development
bsullivan@verastem.com