CAMBRIDGE, Mass., June 28, 2016 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that AbbVie
Inc. has exercised its right to end its collaboration with Infinity
to develop and commercialize duvelisib, an investigational, oral,
dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma. The companies had been in discussions regarding a
potential restructuring of the partnership but were unable to find
a mutually attractive financial structure for continuation of the
collaboration. With the termination of this agreement, Infinity has
regained worldwide rights to duvelisib and neither Infinity nor
AbbVie have future financial obligations to the other party.
"Our partnership with AbbVie and the significant, previously
disclosed, funding was critical to our advancement of duvelisib
through registration-focused clinical studies in indolent
non-Hodgkin lymphoma and chronic lymphocytic leukemia," stated
Adelene Perkins, president and chief
executive officer. "Data reported to date have demonstrated that
duvelisib is clinically active with a manageable safety profile,
and we believe that it could play an important role in the future
treatment of patients with hematologic malignancies, particularly
for relapsing and/or refractory patients. We are now exploring
strategic options for the program that could enable the submission
of global regulatory applications and commercialization for
duvelisib."
In parallel with exploring strategic options for the duvelisib
program, Infinity is continuing to focus on filing a new drug
application (NDA) for duvelisib with the U.S. Food and Drug
Administration (FDA) in the fourth quarter of 2016. The company's
filing strategy includes the incorporation of data from both DUO, a
randomized, Phase 3 monotherapy study in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL), and DYNAMO,
a single-arm, Phase 2 monotherapy study in patients with refractory
indolent non-Hodgkin lymphoma (iNHL). Earlier this month, Infinity
reported that the DYNAMO study met its primary endpoint of overall
response rate and that duvelisib demonstrated a manageable safety
profile in the enrolled patient population. Infinity plans to seek
feedback on the DYNAMO data from the FDA. Infinity also expects to
report topline data from DUO, predicated on the results of an
interim analysis, in the third quarter of 2016.
At this time, Infinity is continuing to focus resources on the
DYNAMO and DUO studies, as well as SYNCHRONY, a combination study
of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma
patients who were previously treated with a Bruton's tyrosine
kinase (BTK) inhibitor and FRESCO, a combination study in patients
with relapsed/refractory follicular lymphoma designed to evaluate
the potential of duvelisib to replace chemotherapy. Infinity plans
to discuss with the FDA the potential for FRESCO to serve as a
confirmatory study for full approval in follicular lymphoma should
duvelisib receive an accelerated approval based on the DYNAMO
study.
Infinity will also reduce its workforce by 58 percent, impacting
100 of Infinity's team members in order to align corporate
resources with the company's strategic decisions which include
closing BRAVURA, a Phase 3 study of duvelisib in patients with
relapsed iNHL, and CONTEMPO, a Phase 1b/2 study of duvelisib in
treatment-naïve patients with follicular lymphoma. Infinity will
not proceed with the Phase 1b/2 study of duvelisib in combination
with venetoclax.
"We have incredibly talented and dedicated Citizen-Owners at
Infinity, and I would like to personally express my gratitude and
appreciation for all of their hard work and contributions. The
decisions we have made are difficult but necessary to enable a path
forward for duvelisib and IPI-549, our second development program.
The team we have in place is deeply committed to exploring
strategic opportunities for duvelisib, and ultimately IPI-549, to
bring benefit to patients," said Ms. Perkins.
IPI-549 is Infinity's wholly owned immuno-oncology development
candidate that selectively inhibits PI3K-gamma. A Phase 1 study of
IPI-549 is ongoing to evaluate the safety, tolerability,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with an anti-PD-1 antibody, a checkpoint
inhibitor, in approximately 150 patients with advanced solid
tumors, including non-small cell lung cancer and melanoma. IPI-549
is the only investigational PI3K-gamma inhibitor in clinical
development.
About Duvelisib
Duvelisib is an investigational
dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma, two proteins that are known to help support the growth
and survival of malignant B-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 being evaluated in several studies, including
DYNAMO, a single-arm, Phase 2 monotherapy study in patients with
refractory indolent non-Hodgkin lymphoma (iNHL)4, DUO, a
randomized, Phase 3 monotherapy study in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL)5,
SYNCHRONY, a Phase 1b combination study designed in patients with
CLL or small lymphocytic lymphoma (SLL) previously treated with a
Bruton's tyrosine kinase (BTK) inhibitor6 and FRESCO, a
Phase 2 combination study in patients with relapsed/refractory
follicular lymphoma.7
About IPI-549
IPI-549 is an investigational,
orally administered immuno-oncology development candidate that
selectively inhibits PI3K-gamma. In preclinical studies, IPI-549
inhibits immune suppressive macrophages within the tumor
microenvironment, whereas other immunotherapies such as checkpoint
modulators more directly target immune effector cell function. As
such, IPI-549 may have the potential to treat a broad range of
solid tumors and represents a potentially complementary approach to
restoring anti-tumor immunity in combination with other
immunotherapies such as checkpoint inhibitors.
Duvelisib and IPI-549 are investigational compounds and their
safety and efficacy have not been evaluated by the U.S. Food and
Drug Administration or any other health authority.
Cautionary Note Regarding Forward-Looking Statements
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
belief that duvelisib may benefit patients with hematologic
malignancies; Infinity's plans to explore strategic options for
duvelisib, and the potential for such options to enable the
submission of global regulatory applications and commercialization
for duvelisib; Infinity's plans to file an NDA for duvelisib in the
fourth quarter of 2016; its plans to report topline data form DUO
in the third quarter of 2016; the expected structure and
benefits of the restructuring; and Infinity's strategic plans and
its ability to execute on such strategic plans. Such statements are
subject to numerous important factors, risks and uncertainties that
may cause actual events or results to differ materially from the
company's current expectations. For example, there can be no
guarantee that Infinity's restructuring will have the intended
benefit of preserving capital; that the Company will be successful
in its efforts to advance the development of duvelisib through a
strategic transaction; or that development of duvelisib or IPI-549
will continue. 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, including subsequent analysis of
existing data and new data received from ongoing and future
studies; unplanned cash requirements and expenditures and
Infinity's ability to secure the substantial additional capital
needed to fund its business; adverse consequences from its
restructuring, including those arising from its reduction in
workforce and programs; competition; and Infinity's ability to
obtain, maintain and enforce patent and other intellectual property
protection for its product candidates. These and other risks which
may impact management's expectations are described under the
caption "Risk Factors" included in Infinity's quarterly report on
Form 10-Q filed with the Securities and Exchange Commission (SEC)
on May 4, 2016, and other filings
filed from time to time 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.
1 Winkler D.G., Faia K.L., DiNitto J.P. et al. (2013)
PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune
responses and suppresses activity in autoimmune and inflammatory
disease models. Chem Biol 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, NCT01882803
5 www.clinicaltrials.gov, NCT02004522
6 www.clinicaltrials.gov, NCT02292225
7 www.clinicaltrials.gov, NCT02605694
Contact:
Jaren Irene Madden
Senior Director, Investor Relations and Corporate
Communications
617-453-1336
Jaren.Madden@infi.com
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SOURCE Infinity Pharmaceuticals, Inc.