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Verastem Licenses Duvelisib from Infinity Pharmaceuticals
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
“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
“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
Terms of Transaction
Under the terms of the license agreement,
Verastem’s Expanded Oncology Pipeline
In addition to duvelisib,
Based on current operating plans including duvelisib,
Conference Call Information
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.
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.
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
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.
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
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
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.
6www.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:
9Sulzmaier FJ et al. FAK in cancer: mechanistic findings and clinical applications. Nature Rev Cancer. 2014 14: 598-610.
11 www.clinicaltrials.gov, NCT02943317
13 www.clinicaltrials.gov, NCT02637531
Brian Sullivan, 781-292-4214
Director, Corporate Development
Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
Senior Director, Investor Relations and Corporate Communications