Transaction Adds Complementary Late-Stage
Product Candidate from a Clinically Validated Drug Class to
Verastem’s Pipeline
Duvelisib Has Demonstrated Clinical Activity in
Lymphoid Malignancies
License of Duvelisib Aligns with Verastem’s
Focus on Targeting the Tumor Microenvironment
Verastem Management to Host Conference Call and
Webcast at 8:30 a.m. ET Today
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 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 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; Infinitity’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.
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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version on businesswire.com: http://www.businesswire.com/news/home/20161102005608/en/
Verastem, Inc.Brian Sullivan, 781-292-4214Director,
Corporate Developmentbsullivan@verastem.comorInfinity
Pharmaceuticals, Inc.Jaren Irene Madden, 617-453-1336Senior
Director, Investor Relations and Corporate
CommunicationsJaren.Madden@infi.com
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