CAMBRIDGE, Mass., Oct. 12, 2017 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that an
abstract describing new data for IPI-549, an orally administered
immuno-oncology development candidate that selectively inhibits
phosphoinositide-3-kinase gamma (PI3K-gamma), has been selected as
a late-breaking presentation during an oral session at the 2017
Society for Immunotherapy of Cancer (SITC) Annual Meeting taking
place in National Harbor, MD, November 10 -
12. Additionally, a clinical trials in progress poster will
also be presented on the Phase 1/1b clinical study which is ongoing
to explore the safety and activity of IPI-549 both as a monotherapy
and in combination with Opdivo® (nivolumab), a PD-1
immune checkpoint inhibitor, in patients with advanced solid
tumors. IPI-549 is believed to be the only PI3K-gamma inhibitor in
clinical development.
Details of the presentations are as follows:
Updated Phase 1/1b Data
Title: Monotherapy dose
escalation clinical and translational data from first-in-human
study in advanced solid tumors of IPI-549, an oral, selective,
PI3K-gamma inhibitor targeting tumor macrophages
Abstract number: O43
Oral session: Clinical Trials - New Agents
Oral session date and time: Friday,
November 10, 2017, from 1:45
p.m. –3:30 p.m. ET
Lead author: David Hong,
M.D., Deputy Chair, Department of Investigational Cancer
Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center,
Houston, TX
Additionally, an identically titled poster will be presented on
Friday, November 10, 2017, from
12:30 p.m. – 2:00 p.m. ET and 6:30
p.m. – 8:00 p.m. ET.
Clinical Trials in Progress
Title: Phase 1/1b,
first-in-human study of the PI3K-gamma inhibitor IPI-549 as
monotherapy and combined with nivolumab in patients with advanced
solid tumors
Abstract number: P219
Poster session: Clinical trials in progress
Presentation time: Friday, November
10, 2017, from 12:30 p.m. –
2:00 p.m. ET and 6:30 p.m. – 8:00 p.m.
ET
Lead author: Antoni Ribas,
M.D., Ph.D., Parker Institute Center Director at the University of California, Los Angeles (UCLA)
About the IPI-549 and the Ongoing Phase 1 Study
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.
A Phase 1 study of IPI-549 in patients with advanced solid
tumors is ongoing 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
will also include a cohort of patients with triple negative breast
cancer (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
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
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 study in patients with advanced solid tumors
is ongoing. For more information on Infinity, please refer to
Infinity's website at www.infi.com.
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, the therapeutic potential of
PI3K-gamma inhibition and of IPI-549, alone or in combination with
other agents, 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 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 3, 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.
OPDIVO® is a registered trademark of Bristol-Myers
Squibb.
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 19, 2017.
5 Conquer Cancer Foundation, Head and Neck Cancer
Statistics,
http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics,
Last Accessed September 19, 2017.
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SOURCE Infinity Pharmaceuticals, Inc.