Infinity Announces IPI-549 Late-Breaking Presentation at SITC 33rd Annual Meeting

Friday, November 2, 2018 Press Release
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-- Combination Expansion Data from the IPI-549 MARIO-1 Phase 1b Study to be Presented --

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 tumorsPoster Number: P716; Abstract Number: 10767Poster Presentation Hours: Saturday, November 10, 2018 at 12:20-1:50 p.m. and 7:00-8:30 p.m. Poster Hall Location: Hall EPresenting 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 StudyIPI-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 InfinityInfinity 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.

Cision View original content:http://www.prnewswire.com/news-releases/infinity-announces-ipi-549-late-breaking-presentation-at-sitc-33rd-annual-meeting-300742527.html

SOURCE Infinity Pharmaceuticals, Inc.



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