Infinity to Present IPI-145 Phase 1 Clinical Data at ASH

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Infinity Pharmaceuticals, Inc. 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.

Responses were observed at each of the lowest dose levels of IPI-145 evaluated, including 8 mg BID, 15 mg BID and 25 mg BID, in patients with chronic lymphocytic leukemia (2 partial responses in 3 patients), indolent non-Hodgkin's lymphoma (1 complete response in 2 patients) and mantle cell lymphoma (1 partial response in 1 patient), for a total of 4 responses among 6 evaluable patients with either chronic lymphocytic leukemia, indolent non-Hodgkin's lymphoma or mantle cell lymphoma. Responses were not observed among five evaluable patients with aggressive non-Hodgkin's lymphoma or multiple myeloma.

The Phase 1 trial is evaluating patients with B-cell and T-cell malignancies in the ongoing dose escalation.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for diseases with significant unmet need. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity's programs focused on the inhibition of phosphoinositide-3-kinase and heat shock protein 90 are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company's website at www.infi.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the expected timing for reporting data regarding IPI-145, the therapeutic potential of IPI-145 and the potential for IPI-145 to be the best-in-class PI3K inhibitor in hematologic malignancies and inflammation. 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. For example, there can be no guarantee that Infinity will report data in the timeframes it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Infinity's product candidates will continue. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations could also be affected by risks and uncertainties relating to: Infinity's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing its product candidates; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption “Risk Factors” included in Infinity's Annual Report on Form 10-K for the year ended December 31, 2011 and subsequent filings filed by Infinity with the Securities and Exchange Commission. 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.