Infinity Reports IPI-145 Phase 1 Data Showing Clinical Activity In B-Cell And T-Cell Malignancies At ASH Annual Meeting

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The Phase 1 study poster is being presented in the Georgia World Congress Center, Hall B1-B2, and may also be found in the Publications Archive on Infinity’s website http://www.infi.com/product-candidates-publications.asp.

Additional Program Updates

Infinity today also provided the following updates related to its PI3K program:

• Continued progress anticipated in Phase 1 dose-escalation trial of IPI-145: Based on data observed to date, Infinity expects to expand its ongoing Phase 1 study of IPI-145 in up to five cohorts based on responses observed during the dose-escalation phase at or below the maximum tolerated dose.
• Update on Phase 2a trial in asthma: Infinity is currently conducting a Phase 2a, randomized, double-blind, placebo-controlled trial of IPI-145 in approximately 30 patients with mild, allergic asthma. Endpoints of this multi-dose, two-way crossover study include safety, pharmacokinetics and FEV1, a standard measure of lung function. The company expects to provide an update on this study in 2013.
• Planning for Phase 2 trial in RA continuing: In November 2012, Infinity presented data from its completed Phase 1 trial of IPI-145 in healthy subjects. Infinity believes that these data, combined with preclinical data in multiple animal models of rheumatoid arthritis (RA), support Phase 2 development in this indication. Infinity expects to begin a Phase 2 trial of IPI-145 in patients with moderate to severe RA in the first half of 2013.
• Follow-on PI3K inhibitor expected: Infinity is developing a portfolio of novel PI3K-delta and/or PI3K-gamma inhibitors. The company expects to announce its first follow-on PI3K development candidate by the end of this year and is planning to complete nonclinical studies by the end of 2013, which are designed to enable Phase 1 development.

Investor Reception and Webcast

Infinity will host a reception on Monday, December 10, 2012, from 8:00 p.m. to 10:00 p.m. ET to discuss IPI-145 and to review the data presented at ASH. In addition to Infinity management, speakers will include Dr. Ian Flinn, director, hematologic malignancies research program, Sarah Cannon Research Institute; Dr. Steven Horwitz, assistant attending physician, department of medicine, Memorial Sloan-Kettering Cancer Center; and Dr. Brad Kahl, associate professor, University of Wisconsin School of Medicine and Public Health and associate director for clinical research, University of Wisconsin Carbone Cancer Center. The presentation portion of the reception will be webcast beginning at 8:45 p.m. ET. The webcast and accompanying slides can be accessed in the “investors/media” section of Infinity’s website, www.infi.com. A replay of the event will also be available.

About Infinity’s PI3K Program

IPI-145 is a potent, oral inhibitor of Class I phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity believes IPI-145 is the only PI3K-delta and -gamma inhibitor in clinical development. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. ¹ The PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes, where they have distinct and non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of inflammatory diseases as well as hematologic malignancies.

In addition to its ongoing Phase 1 trial in patients with advanced hematologic malignancies, Infinity is conducting a Phase 2a, randomized, double-blind, placebo-controlled, multi-dose, cross-over study of IPI-145 in patients with asthma. The company is also planning a Phase 2 trial of IPI-145 in rheumatoid arthritis.

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