CAMBRIDGE, Mass.,
Sept. 19, 2016 /PRNewswire/ -- Infinity Pharmaceuticals,
Inc. (NASDAQ: INFI) today announced the publication of new findings
by research collaborators at University of
California San Diego School of Medicine and Moores Cancer
Center and Infinity scientists in the September 19 online issue of Nature. The
paper, entitled "PI3K-gamma is a molecular switch that controls
immune suppression,"1 describes research showing that
targeting macrophage signaling pathways by inhibiting
phosphoinositide-3-kinase (PI3K)-gamma may open the possibility to
further improving and refining emerging immunotherapies that boost
the body's own abilities to fight a range of diseases, including
cancer. Infinity is conducting a Phase 1 clinical study of IPI-549,
an orally administered immuno-oncology development candidate that
selectively inhibits PI3K-gamma. IPI-549 is the only PI3K-gamma
inhibitor in clinical development.
"Immunotherapies, such as T cell checkpoint inhibitors, are
showing great promise in early treatments and trials, but they are
not universally effective," said Judith A.
Varner, PhD, professor in the departments of Pathology and
Medicine at UC San Diego School of Medicine. "We have identified a
new method to boost the effectiveness of current immune therapy.
Our findings also improve our understanding of key mechanisms that
control cancer immune suppression and could lead to the development
of more effective immunotherapies."
"The findings published today build upon other work by Infinity
and our collaborators, reinforcing the therapeutic potential of
Infinity's selective PI3K-gamma inhibitor, IPI-549, to alter the
immune-suppressive microenvironment, promoting an anti-tumor immune
response that leads to tumor growth inhibition," stated
Jeffery Kutok, M.D., Ph.D., vice
president of biology and translational science at Infinity
Pharmaceuticals and a co-author of the paper. "Infinity is excited
to be at the forefront of advancing PI3K-gamma inhibition as a new
immunotherapeutic approach that could potentially enhance existing
treatment options, including checkpoint inhibitors."
When confronted by pathogens, injury or disease, the initial
response of the body's immune system comes in the form of
macrophages, a type of white blood cell that express
pro-inflammatory proteins called cytokines that, in turn, activate
T cells, another immune cell, to attack the health threat. The
macrophages then switch gears to express other cytokines that
dampen T cell activation, stimulating tissue repair. In cancer,
highly abundant macrophages express anti-inflammatory cytokines
that induce immune suppression, leading to enhanced tumor
growth.
In the Nature paper, researchers pinpoint a key,
suspected player: an enzyme in macrophages called PI3K-gamma. In
mouse studies, they found that macrophage PI3K-gamma signaling
promotes immune suppression by inhibiting activation of anti-tumor
T cells. Blocking PI3K-gamma activated the immune response and
significantly suppressed growth of implanted tumors in animal
models. It also boosted sensitivity of some tumors to existing
anti-cancer drugs and synergized with existing immune therapy to
eradicate tumors. Researchers also identified a molecular
signature of immune suppression and response in mice and cancer
patients that may be used to track the effectiveness of immune
therapy.
Earlier this year, Infinity initiated its first clinical study
of IPI-549 designed to explore 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.2
"Infinity's first clinical study of IPI-549 is progressing well,
and we expect to initiate the first combination therapy cohort this
Fall," said Julian Adams, Ph.D.,
president, research and development at Infinity. "We also look
forward to the presentation of early clinical and new preclinical
data at an immuno-therapy conference later this month."
Recently, Infinity announced that new preclinical data as well
as early clinical data from the ongoing Phase 1 study will be
presented for IPI-549 during the Second CRI-CIMT-EATI-AACR
International Cancer Immunotherapy Conference: Translating Science
into Survival taking place September 25-28,
2016, in New York City. The
IPI-549 presentations will take place during the poster session
being held on Monday, September 26,
from 5:15 p.m. – 7:45 p.m. ET (Poster Boards B070 and B032).
About IPI-549
IPI-549 is an 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.
IPI-549 is an investigational compound and its safety and
efficacy has 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
including those regarding the company's expectations about the
timing and type of data presentations and the therapeutic potential
of PI3K-gamma inhibition and of IPI-549, alone or in combination
with other agents. 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, including, for example, that there is no guarantee
that IPI-549 will successfully complete necessary preclinical and
clinical development phases, or gain regulatory approval and other
risks 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.
Contact:
Jaren Irene
Madden, Senior Director, Investor Relations and Corporate
Communications
617-453-1336 or Jaren.Madden@infi.com
1 Kaneda, M.M., Messer, K.S., Ralainirina N. et al.
Nature, Advanced Online Publication, September 2016, http://www.nature.com/nature.
2 www.clinicaltrials.gov, NCT02637531
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SOURCE Infinity Pharmaceuticals, Inc.