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Press release from Business Wire

Infinity Announces Clinical Data to Be Presented at ASCO and ICML

Wednesday, May 15, 2013

Infinity Announces Clinical Data to Be Presented at ASCO and ICML

18:37 EDT Wednesday, May 15, 2013

CAMBRIDGE, Mass. (Business Wire) -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that Phase 1 clinical data for IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held from May 31 through June 4 in Chicago, Ill., and the 12th International Conference on Malignant Lymphoma (ICML), which is being held from June 19 through June 22 in Lugano, Switzerland. Key clinical results to be presented during both meetings include updated data from Infinity's Phase 1 study evaluating the safety, clinical activity and pharmacokinetics of IPI-145 in people with advanced hematologic malignancies (blood cancers).

In addition, Infinity will host a reception on Monday, June 3, 2013, from 8:00 p.m. to 9:30 p.m. CT (9:00 p.m. to 10:30 p.m. ET) in Chicago, Ill., to review its PI3K program in hematologic malignancies and discuss IPI-145 data being presented at the ASCO 2013 Annual Meeting. The reception will be webcast beginning at 8:30 p.m. CT (9:30 p.m. ET) and can be accessed in the Investors/Media section of Infinity's website at www.infi.com. An archived version of the webcast will be available on Infinity's website for 30 days.

Presentations at ASCO 2013 include the following:
Sunday, June 2, 2013, 8:00 a.m. – 11:45 a.m. CT (poster presentation)
Title: Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory CLL (Abstract #7070)
Presenter: Manish R. Patel, M.D., Florida Cancer Specialists & Research Institute, Sarasota, FL and Sarah Cannon Research Institute, Nashville, TN
Location: S Hall A2

Monday, June 3, 2013, 11:30 a.m. – 11:45 a.m. CT (oral presentation)
Title: Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory lymphoma (Abstract #8518)
Presenter: Steven M. Horwitz, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY
Location: E354a

Presentations at ICML 2013 include the following:
Wednesday, June 19, 2013, 12:00 p.m. – 6:30 p.m. Central European Time (CET) (poster presentation)
Title: Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory T-cell lymphoma (Abstract #294)
Presenter: Steven M. Horwitz, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY

Thursday, June 20, 2013, 4:05 p.m. – 4:20 p.m. CET (oral presentation)
Title: Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory B-cell lymphoma(Abstract #66)
Presenter: Brad Kahl, M.D., University of Wisconsin School of Medicine and Public Health, Madison, WI

Saturday, June 22, 2013, 8:30 a.m. – 8:40 a.m. CET (oral presentation)
Title: Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory CLL/SLL (Abstract #145)
Presenter: Ian W. Flinn, M.D, Ph.D.,Sarah Cannon Research Institute, Nashville, TN

About Infinity's PI3K Program in Blood Cancer
Infinity is developing IPI-145 and IPI-443, potent, oral inhibitors of Class I phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. 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 (white blood cells), 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 hematologic malignancies and inflammatory diseases.

IPI-145, Infinity's lead product candidate, is currently progressing in a Phase 1 study in people with advanced hematologic malignancies. Preliminary data from this trial suggest that IPI-145 is well tolerated to date and clinically active in patients with both B-cell and T-cell malignancies, including chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma, mantle cell lymphoma, Hodgkin lymphoma and T-cell lymphoma.2 Also, Infinity recently announced that an investigator-sponsored Phase 1b, open-label, dose-escalation study of IPI-145 in people with B-cell NHL, CLL and T-cell lymphoma in combination with rituxan (a monoclonal antibody therapy), bendamustine (a chemotherapy) or both rituxan and bendamustine is open for enrollment.

About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. 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 Company's expectations about: the timing and type of data reports from clinical trials of IPI-145; and the therapeutic potential of its PI3K inhibitors. 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 time frames 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 and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: 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 obtain and maintain requisite regulatory approvals and 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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2013, and other filings filed by Infinity with the SEC. 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.

1 Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK (Eds.) The biology of cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.
2 Flinn, I.W., Horwitz, S.M., Patel, M., Younes, A., Porter, J., Sweeney, J., Allen, K., Kelly, P., Kahl, B. Clinical Safety and Activity in a Phase 1 Trial of IPI-145, a Potent Inhibitor of Phosphoinositide-3-Kinase-(δ,γ) in Patients with Advanced Hematologic Malignancies. Poster presented at the 54th Annual Meeting of the American Society for Hematology (ASH), Atlanta, GA, 2012.

Infinity Pharmaceuticals, Inc.
Jaren Madden, 617-453-1336
Jaren.Madden@infi.com
http://www.infi.com

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