CAMBRIDGE, Mass.,
Sept. 25, 2017 /PRNewswire/ -- Infinity Pharmaceuticals,
Inc. (NASDAQ: INFI) today announced that it has expanded its
existing clinical collaboration with Bristol-Myers Squibb
evaluating IPI-549 in combination with Opdivo® to
include patients with triple negative breast cancer (TNBC) who have
not been previously exposed to anti-PD-1 or anti-PD-L1 therapy.
IPI-549 is an oral, selective phosphoinositide-3-kinase gamma
(PI3K-gamma) inhibitor which targets immune-suppressive tumor
macrophages, and Opdivo is a PD-1 immune checkpoint inhibitor
designed to overcome immune suppression. IPI-549 is currently being
evaluated in a Phase 1/1b clinical study in patients with advanced
solid tumors and is believed to be the only selective PI3K-gamma
inhibitor in clinical development.
Preclinical data have demonstrated that M2, or pro-tumor,
macrophages are associated with resistance to checkpoint inhibitor
monotherapy, and treatment with IPI-549 in combination with
checkpoint inhibitors can overcome this resistance by reprogramming
macrophages from the M2 phenotype to the M1, or anti-tumor,
phenotype.1,2 A component of this ongoing Phase 1/1b
study is designed to explore the potential of combining these two
agents to overcome resistance in patients previously treated with
checkpoint inhibition. The addition of a cohort of patients with
TNBC who have not previously received anti-PD-1 or anti- PD-L1
therapy provides an important opportunity to explore the potential
of the combination of IPI-549 and Opdivo to improve efficacy
for patients with a type of cancer where there is limited benefit
from monotherapy treatment with checkpoint inhibitors.
"The expansion of our ongoing clinical study of IPI-549 and our
clinical collaboration with Bristol-Myers Squibb represents an
important component of our strategy to bring better treatment
options to patients," stated Adelene
Perkins, chief executive officer at Infinity. "Particularly,
expanding our study to include patients with triple negative breast
cancer who have not been previously treated with a PD-1 or PD-L1
immune checkpoint inhibitor allows us to evaluate whether IPI-549
in combination with Opdivo can increase the number of
patients who respond to checkpoint inhibition. To date, very few
patients with triple negative breast cancer respond to checkpoint
inhibitors alone, leaving these patients with very limited
therapeutic options."
The ongoing Phase 1/1b study being conducted by Infinity is
designed to evaluate the safety, tolerability, activity,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo in approximately 200 patients
with advanced solid tumors.3 The four-part study
includes monotherapy and combination dose-escalation components, in
addition to monotherapy expansion and combination expansion
components. Patient enrollment is complete in monotherapy
dose-escalation, and monotherapy expansion is ongoing. Combination
dose-escalation is also ongoing, and combination expansion is
expected to begin in the second half of 2017.
The combination expansion component includes multiple cohorts
designed to evaluate IPI-549 in patients with specific types of
cancer, including patients with non-small cell lung cancer (NSCLC),
melanoma, and head and neck squamous cell carcinoma (HNSCC) whose
tumors show initial resistance or subsequently develop resistance
to immune checkpoint blockade therapy. This combination expansion
component will now also add a cohort of patients with TNBC who have
not been previously exposed to immune checkpoint blockade therapy.
Although there has been great progress in the treatment of cancer,
there remains a need for additional treatment options. NSCLC,
melanoma, HNSCC and TNBC account for more than 22 percent of all
new cancer cases in the U.S.4,5
About IPI-549
IPI-549 is an investigational, orally
administered immuno-oncology development candidate that selectively
inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms
macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype
and is able to overcome resistance to checkpoint inhibition as well
as to enhance the activity of checkpoint inhibitors.1,2
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.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to
advancing novel medicines for people with cancer. Infinity is
developing IPI-549, an oral immuno-oncology development candidate
that selectively inhibits PI3K-gamma. A Phase 1/1b study in
patients with advanced solid tumors is ongoing.3 For
more information on Infinity, please refer to Infinity's website at
www.infi.com.
Infinity's 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: the therapeutic potential of PI3K-gamma selective
inhibition and IPI-549, alone and in combination with checkpoint
inhibitors, including Opdivo; and clinical trial plans regarding
IPI-549. 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 IPI-549 will successfully
complete necessary preclinical and clinical development phases, or
that development of any of Infinity's product candidates 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; the content and timing of decisions made by the
U.S. FDA and other regulatory authorities; the failure of
Infinity or Bristol-Myers Squibb to perform under their clinical
supply collaboration agreement; Infinity's ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trials; unplanned cash requirements and expenditures;
development of agents by Infinity's competitors for diseases in
which Infinity is currently developing or intends to develop
IPI-549; 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 for the quarter ended June 30, 2017, 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., Messer, K., Ralainirina, N., Li, H., et
al. PI3Kγ is a molecular switch that controls immune suppression.
Nature, 2016 Nov;539:437–442.
2 De Henau, O., Rausch, M., Winkler, D., Campesato, L.,
et al. Overcoming resistance to checkpoint blockade therapy by
targeting PI3Kγ in myeloid cells. Nature, 2016
Nov;539:443-447.
3 www.clinicaltrials.gov, NCT02637531.
4 American Cancer Society, Cancer Facts and Statistics
2017,
http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index
and
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics,
Last Accessed September 22, 2017.
5 Conquer Cancer Foundation, Head and Neck Cancer
Statistics,
http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics,
Last Accessed September 22, 2017.
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SOURCE Infinity Pharmaceuticals, Inc.