BOSTON and CAMBRIDGE, Mass., Nov.
2, 2016 /PRNewswire/ -- Verastem, Inc. (NASDAQ: VSTM)
and Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), today announced
that the companies entered into a license agreement under which
Verastem licensed exclusive worldwide rights to develop and
commercialize Infinity's oncology product candidate duvelisib.
Duvelisib is an oral inhibitor of phosphoinositide-3-kinase
(PI3K)-delta and PI3K-gamma being investigated for the treatment of
hematologic cancers, including chronic lymphocytic leukemia (CLL),
indolent non-Hodgkin lymphoma (iNHL) and T cell lymphomas. Verastem
will pay to Infinity up to $28
million in milestones, with positive data from
DUO®, a Phase 3, randomized monotherapy study of
duvelisib in patients with relapsed/refractory CLL, triggering the
first milestone payment, and royalties on net sales.
"Duvelisib is a clinically validated, late-stage product
candidate with a proven mechanism of action. This transaction has
an attractive risk/reward profile given the modest financial
investment prior to obtaining topline data from the DUO study,
currently anticipated in the first half of 2017, as well as the
potential applications for a variety of other lymphoid
malignancies," said Robert
Forrester, President and Chief Executive Officer of
Verastem. "Duvelisib complements Verastem's oncology pipeline by
augmenting our strategic focus of developing small molecule agents
that target malignant cells both directly and through modulation of
the tumor microenvironment. This transaction represents a positive
step toward our goal of bringing new treatment options to patients
with cancer. We are working closely with Infinity to ensure a
smooth transition of the duvelisib program."
"The potential of duvelisib is supported by clinical data
demonstrating anti-cancer activity and a manageable safety profile
in a wide range of lymphoid malignancies, including
relapsed/refractory iNHL, CLL and T cell lymphomas,"
said Gregory I. Berk, MD, Chief Medical Officer
of Verastem. "While there have been significant advances
recently in the treatment of lymphoid malignancies, not all
patients experience benefits or can tolerate these treatments.
There remains a need for new oral medicines, and the targeted
inhibition of PI3K-delta and PI3K-gamma brings a unique approach
designed to address both the malignant B cell and its supportive
microenvironment. We look forward to reporting data from the DUO
study, which could enable a submission for regulatory
approval."
"Infinity has always been committed to finding innovative ways
to develop novel medicines which hold significant promise for
people living with cancer. Verastem provides duvelisib the best
opportunity to advance toward regulatory filings and potential
commercialization given their oncology-focused capabilities and
deep knowledge of the tumor microenvironment," stated Adelene Perkins, President and Chief Executive
Officer of Infinity. "Additionally, the license of duvelisib
fulfills an important strategic goal for Infinity by preserving
cash while enabling our shareholders to participate in the value of
the duvelisib program through potential milestone payments and
royalties to Infinity."
Terms of Transaction
Under the terms of the license agreement, Verastem is obligated to
pay to Infinity up to $28 million in
milestones. Infinity is entitled to receive two milestone payments,
$6 million upon positive data from
the DUO study and $22 million upon
the first regulatory approval inside or
outside of the U.S. Verastem will also pay Infinity tiered
mid-to-high single-digit royalties on net sales and will be
responsible for the single-digit-royalty on net sales of duvelisib
owed by Infinity to MundiPharma International Corporation Limited
and Purdue Pharmaceutical Products L.P.
Verastem's Expanded Oncology Pipeline
In addition to
duvelisib, Verastem also holds worldwide rights to the tumor
microenvironment-targeting focal adhesion kinase (FAK) inhibitors
defactinib (VS-6063) and VS-4718. Verastem's lead FAK inhibitor,
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 or
avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.
Verastem also owns rights to the FAK inhibitor VS-4718 and the dual
PI3K and mTORC1/2 inhibitor VS-5584 which are both currently being
evaluated in Phase 1 clinical studies.
Financial Guidance
Based on current operating plans
including duvelisib, Verastem expects to have sufficient cash, cash
equivalents and short-term investments to fund its research and
development programs and operations into 2018.
Conference Call Information
Verastem will host a
conference call on November 2, 2016,
at 8:30 a.m. ET to discuss the
license agreement announced today.
The call can be accessed by dialing 877-341-5660 (U.S. and
Canada) or 315-625-3226
(international), and entering passcode 12230467. To access the live
webcast, please use either the following link:
http://edge.media-server.com/m/p/vsavfj6j or visit the investors
section of the Verastem website at www.verastem.com. A replay of
the call will be available on the Company's website for a period of
180 days from today.
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 lymphoma6.
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 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.
About Infinity Pharmaceuticals, Inc.
Infinity is an
innovative biopharmaceutical company dedicated to advancing novel
medicines for people with cancer. Infinity is advancing IPI-549, an
oral immuno-oncology development candidate that selectively
inhibits PI3K-gamma. A Phase 1 study in patients with advanced
solid tumors is ongoing.13 For more information on
Infinity, please refer to Infinity's website at www.infi.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
candidates, duvelisib, defactinib (VS-6063), VS-4718 and VS-5584,
and Verastem's FAK, PI3K/mTOR 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, our rights to develop or
commercialize our product candidates and our ability to finance
contemplated development activities and fund operations for a
specified period. 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 the cost of the transaction to Verastem will not
provide the intended positive financial results; 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.
Infinity Pharmaceuticals, Inc. forward-looking statements
notice:
This press release contains forward-looking
statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include those regarding
Infinity's expectations about: the receipt of milestone and
royalty payments under the agreement with Verastem; the therapeutic
and commercial potential of duvelisib and PI3K inhibition; Infinity's ability to transition the
duvelisib program to Verastem; the preservation of Infinity's cash;
and Infinity's ability to execute on its strategic plans. Such
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from Infinity's current expectations. For example, there
can be no guarantee that the transition of the duvelisib program to
Verastem will be completed or that Infinity will receive any of the
benefits of the agreement with Verastem including the receipt of
milestone and royalty payments. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other factors, including the following: Infinity's
results of clinical trials and preclinical studies; a failure of
Infinity and/or Verastem to fully perform under the
license agreement; the content and timing of decisions made by the
U.S. FDA and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies; Infinity's ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trial of IPI-549; unplanned cash requirements and
expenditures; development of agents by Infinity's competitors for
diseases in which Infinity is currently developing or intends to
develop its product candidates; and Infinity's ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing. These and
other risks which may impact management's expectations are
described in greater detail under the caption "Risk Factors"
included in Infinity's quarterly report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on August 9,
2016, and other filings filed by Infinity with the SEC. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Infinity expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
CONTACTS:
Verastem, Inc.
Brian Sullivan
Director, Corporate Development
781-292-4214
bsullivan@verastem.com
Infinity Pharmaceuticals, Inc.
Jaren Irene Madden
Senior Director, Investor Relations and Corporate
Communications
617-453-1336
Jaren.Madden@infi.com
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.
8 Jiang 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.
10 www.clinicaltrials.gov, NCT02546531
11 www.clinicaltrials.gov, NCT02943317
12 www.clinicaltrials.gov, NCT02758587
13 www.clinicaltrials.gov, NCT02637531
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SOURCE Infinity Pharmaceuticals, Inc.