CAMBRIDGE, Mass., Nov. 1, 2018 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that an abstract describing data from the expansion of the MARIO-1 Phase
1b Study of IPI-549 in combination with nivolumab in advanced solid tumors has been selected as a
late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting
in Washington D.C., November 7 – 11. Details of the presentation are as follows:
Title: The first clinical/translational data from the expansion cohorts of a Ph1/1b Study
of IPI-549, a tumor macrophage-reprogramming small molecule, in combination with nivolumab in advanced solid tumors
Poster Number: P716; Abstract Number: 10767
Poster Presentation Hours: Saturday, November 10, 2018 at 12:20-1:50
p.m. and 7:00-8:30 p.m.
Poster Hall Location: Hall E
Presenting Author: Ryan J. Sullivan, M.D., Massachusetts General Hospital, PI for the MARIO-1 Study
Infinity will also host a reception for investors and analysts on Saturday, November 10, 2018,
from 6:30 a.m. to 7:30 a.m. ET to discuss these results. The event will feature 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. There will also be a panel discussion with David Hong,
M.D., and, from Infinity Pharmaceuticals, Sam Agresta, M.D., M.P.H., CMO, and Jeffery Kutok, M.D., Ph.D., CSO.
About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated
myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage
function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram
macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the
activity of, and overcome resistance to, checkpoint inhibitors.i ii As such, IPI-549 may have the potential to
treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor
immunity in combination with other immunotherapies such as checkpoint inhibitors.
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 nivolumab
(Opdivo®) in approximately 200 patients with advanced solid tumors.iii The study includes monotherapy
and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The
monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete,
and combination expansion cohorts are enrolling.
The combination expansion component of the study 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 cancer whose
tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy.
The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not
been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients
with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.
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 advancing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase
1/1b study in approximately 200 patients with advanced solid tumors is ongoing. For more
information on Infinity, please refer to Infinity's website at www.infi.com.
Contact:
Stephanie Ascher, Stern Investor Relations, Inc.
212-362-1200 or stephanie@sternir.com
i Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3K? is a molecular switch that controls immune
suppression. Nature, 2016 Nov;539:437–442.
ii De Henau, O., Rausch, M., Winkler, D., Campesato, L., et al. Overcoming resistance to checkpoint blockade
therapy by targeting PI3K? in myeloid cells. Nature, 2016 Nov;539:443-447.
iii www.clinicaltrials.gov,
NCT02637531.
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SOURCE Infinity Pharmaceuticals, Inc.