PARIS, March 6, 2017 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that Phase 1
clinical data for IPI-549, an orally administered immuno-oncology
development candidate that selectively inhibits
phosphoinositide-3-kinase gamma (PI3K-gamma), were presented during
a plenary session at the 15th International Congress on
Targeted Anticancer Therapies (TAT 2017) taking place in
Paris, France, March 6 – 8. A Phase 1 clinical study 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 selective PI3K-gamma
inhibitor in clinical development.
"The TAT congress has become a leading conference for Phase 1
clinical studies in oncology, so it is an honor to be invited to
participate in a plenary session to discuss our progress with
IPI-549 at this year's congress," commented Claudio Dansky Ullmann, M.D., senior vice
president, clinical development at Infinity.
Today's presentation at TAT 2017 included updated Phase 1 data from
12 patients enrolled in the monotherapy dose-escalation phase of
the ongoing study. The presentation, "A Phase 1/1b, First-in-Human
Study of IPI-549, a PI3K-Gamma Inhibitor and Myeloid Targeting
Agent, as Monotherapy and in Combination with Nivolumab in Patients
with Advanced Solid Tumors," was given by Anthony Tolcher, M.D., FRCP(C), clinical
director at South Texas Accelerated Research Therapeutics, an
investigator for the Phase 1 study and the recipient of the TAT
2016 Honorary Award Invited Lecture.
"Based on the experience of patients in my clinic, I am
encouraged about the potential of IPI-549, and the data to date
suggest that the safety, pharmacokinetics and pharmacodynamics of
monotherapy treatment appear favorable," stated Dr. Tolcher.
"IPI-549 holds the promise of offering a unique approach for
enhancing the body's anti-tumor immune response, and I look forward
to continuing to participate in this Phase 1 clinical study."
Additionally, IPI-549 was discussed today during the TAT 2017
Honorary Award Invited Lecture, "Immunologic Checkpoint Blockade:
Exploring Combinations and Mechanisms," which was given by
Jedd Wolchok, M.D., Ph.D., Chief of
the Melanoma and Immunotherapeutics Service at Memorial Sloan
Kettering Cancer Center (MSK), as well as Associate Director of the
Ludwig Center for Cancer Immunotherapy and Director of the Parker
Institute for Cancer Immunotherapy, both at MSK. Dr. Wolchok serves
as the lead investigator for the Phase 1 clinical study of IPI-549.
He is also an author on the recently published Nature paper
which described that the presence of suppressive myeloid cells is
critical in tumor resistance to checkpoint inhibitors and targeting
PI3K-gamma in these cells with IPI-549 is able to help overcome
this resistance.1
"This is an exciting time in the field of immuno-oncology. New
immunotherapies, such as checkpoint inhibitors, underscore the
progress we have made in the treatment of various cancers. Even so,
we are always exploring new avenues of investigation that we hope
will benefit even more patients," stated Dr. Wolchok. "IPI-549 is
one of the newer and potentially promising immunotherapies in
clinical development. Our research suggests IPI-549 could offer a
unique way to both enhance the activity of checkpoint inhibition in
sensitive tumors, as well as to overcome tumor resistance to
checkpoint inhibition."
IPI-549 Poster Presentation at Upcoming AACR Annual Meeting
2017
Last week, Infinity announced that updated Phase 1
data for IPI-549 will be presented at the American Association for
Cancer Research (AACR) Annual Meeting 2017 taking place in
Washington, D.C. April 1 – 5. Details of the presentation are as
follows:
Poster presentation time: Tuesday,
April 4, 2017, 8:00 a.m. –
12:00 p.m. ET
Title: IPI-549-01 - A Phase 1/1b, First-in-Human Study of
IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination
with Nivolumab in Patients with Advanced Solid Tumors
Abstract number: CT089
Lead author: Jedd Wolchok,
M.D., Ph.D., Chief of the Melanoma and Immunotherapeutics Service
at Memorial Sloan Kettering Cancer Center (MSK), as well as
Associate Director of the Ludwig Center for Cancer Immunotherapy
and Director of the Parker Institute for Cancer Immunotherapy, both
at MSK
Location: Convention Center, Halls A-C, Poster Section
33
Due to AACR embargo policies, the data presented today at TAT
2017 will be made available during the AACR Annual Meeting
2017.
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 increases antitumor immunity by
targeting tumor-associated myeloid cells and overcomes immune
checkpoint blockade resistance in preclinical tumor
models.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 explore the activity, safety, tolerability,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo® in patients with
advanced solid tumors.3 The study includes monotherapy
and combination dose-escalation phases, in addition to a
monotherapy expansion cohort and combination expansion cohorts.
Overall, the study is expected to enroll approximately 175
patients.
The expansion cohorts evaluating IPI-549 plus Opdivo will
include patients with non-small cell lung cancer (NSCLC), melanoma
and squamous cell carcinoma of the head and neck (SCCHN). There is
a great need for additional treatment options for the growing
number of patients living with these types of cancers, which
account for more than 17 percent of all new cancer cases in the
U.S.4,5 Additionally, patients enrolled in
the combination expansion cohorts represent a difficult-to-treat
population, as they must have demonstrated initial resistance or
subsequently develop resistance to a PD-1 or PD-L1 therapy
immediately prior to enrolling in the study.
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 November 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.
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 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.
2 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.
3 www.clinicaltrials.gov, NCT02637531.
4 American Cancer Society, Cancer Facts and
Statistics 2016,
http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index
and
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics,
Last Accessed March 2, 2017.
5 Conquer Cancer Foundation, Head and Neck Cancer
Statistics,
http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics,
Last Accessed March 2, 2017.
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SOURCE Infinity Pharmaceuticals, Inc.