Infinity To Present IPI-145 Phase 1 Clinical Data At ASH

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that data from its ongoing Phase 1 trial of IPI-145, the company’s potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma will be presented at the 54 ^th American Society of Hematology (ASH) Annual Meeting and Exhibition. The Phase 1 trial of IPI-145 is an open-label, dose-escalation study evaluating IPI-145 in patients with advanced hematologic malignancies. The presentation will include data describing the safety, pharmacokinetics and clinical activity of IPI-145. The ASH meeting is being held in Atlanta, Georgia, from December 8 – 11, 2012.

“In this ongoing Phase 1 trial, we are very encouraged by the activity observed at the three lowest dose levels of IPI-145 evaluable for response, including responses in patients with chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma and mantle cell lymphoma. We have continued to make progress in this study since submitting our abstract in July. Specifically, dose escalation is still ongoing, and we expect to soon complete patient enrollment in our first expansion cohort evaluating IPI-145 at a dose of 25 mg twice daily in the same indications for which we have seen responses,” stated Julian Adams, Ph.D., president of R&D at Infinity. “We look forward to presenting updated data from this study, which will include additional safety and efficacy data from the first expansion cohort as well as the ongoing dose escalation in patients with both B-cell and T-cell malignancies.”

“IPI-145 has a number of distinct features, including high potency against PI3K-delta, the ability to inhibit PI3K-gamma and dose proportional pharmacokinetics. We believe that these properties have the potential to translate into benefits for patients and establish IPI-145 as the best-in-class PI3K inhibitor in hematologic malignancies as well as inflammation,” Dr. Adams continued.

Infinity will also 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. The reception will be webcast beginning at 8:45 p.m. ET and can be accessed in the “investors/media” section of Infinity’s website, www.infi.com. A replay of the event will also be available.

Poster Presentation Details

• Title: Clinical safety and activity in a Phase 1 trial of IPI-145, a potent inhibitor of phosphoinositide-3-kinase (PI3K)-delta,gamma in patients with advanced hematologic malignancies (Abstract #3663)
• Time: 10:00 a.m. – 8:00 p.m. ET (viewing) and 6:00 p.m. – 8:00 p.m. (presentation)
• Presenter: Ian W. Flinn, M.D., Ph.D., Director, Hematologic Malignancies Research Program, Sarah Cannon Research Institute
• Location: Georgia World Congress Center, Hall B1-B2.

Abstract Highlights

The abstract accepted for presentation at ASH includes an evaluation of the safety, activity and pharmacokinetics of IPI-145 as of July 16, 2012. At the time of the data cutoff, 20 patients were evaluable for safety and 11 patients were evaluable for efficacy. Twice daily (BID) doses of IPI-145 evaluated included 8 mg, 15 mg, 25 mg, 35 mg and 50 mg, which were generally well tolerated. A single dose-limiting toxicity was observed at the 15 mg BID dose level. Treatment-related adverse events occurred in 11 of 20 evaluable patients, with Grade 3 and 4 events occurring in five patients. Based on the tolerability observed to date, dose escalation remains ongoing and a maximum tolerated dose has not been reached.

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