Infinity Announces Clinical and Preclincal Data for Duvelisib to Be Presented at ASH 2014 Annual Meeting

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

Infinity Pharmaceuticals, Inc. INFI today announced that new data for duvelisib (IPI-145), an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at the American Society of Hematology (ASH) 2014 Annual Meeting, which is being held December 6-9 in San Francisco, CA.

Key results to be presented during the meeting include translational data showing the complementary effects of inhibiting both PI3K-delta and PI3K-gamma as well as updated data from the Phase 1 study evaluating the safety and activity of duvelisib in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) and relapsed/refractory chronic lymphocytic leukemia (CLL). Updated Phase 1 data on the activity of duvelisib in patients with T-cell lymphoma will also be reported.

Presentations of duvelisib at ASH 2014 include the following:

Sunday, December 7, 2014, 6:00 p.m. – 8:00 p.m. PT (poster presentation)

Title: Duvelisib (IPI-145), a PI3K-δ,γ inhibitor, is clinically active in patients with relapsed/refractory chronic lymphocytic leukemia

Abstract Number: 3334

Lead Author: Susan O'Brien, MD, Ashbel Smith Professor and Chief, Section of Acute Lymphocytic Leukemia in the Department of Leukemia, University of Texas, M.D. Anderson Cancer Center

Location: Moscone Center, West Building, Level 1

Sunday, December 7, 2014, 6:00 p.m. – 8:00 p.m. PT (poster presentation)

Title: Clinical activity of duvelisib (IPI-145), a phosphoinositide-3-kinase-δ,γ inhibitor, in patients previously treated with ibrutinib

Abstract Number: 3335

Lead Author: Pierluigi Porcu, M.D., Associate Professor of Internal Medicine, Division of Hematology and Comprehensive Cancer Center, Ohio State University

Location: Moscone Center, West Building, Level 1

Monday, December 8, 2014, 7:45 a.m. – 8:00 a.m. PT (oral presentation)

Title: Duvelisib (IPI-145) inhibits malignant B-cell proliferation and disrupts signaling from the tumor microenvironment through mechanisms that are dependent on PI3K-δ and PI3K-γ

Abstract Number: 328

Lead Author: Marisa Peluso, Scientist, Cancer Biology, Infinity Pharmaceuticals, Inc.

Location: Moscone Center, West Building, 3001-3003-3014-3016

Tuesday, December 9, 2014, 8:15 a.m. – 8:30 a.m. PT (oral presentation)

Title: A Phase 1 evaluation of duvelisib (IPI-145), a PI3K-δ,γ inhibitor, in patients with relapsed/refractory iNHL

Abstract Number: 802

Lead Author: Ian W. Flinn, M.D., Sarah Cannon Research Institute, Nashville, TN.

Location: Moscone Center, West Building, 2005-2007-2018-2020

Tuesday, December 9, 2014, 8:30 a.m. – 8:45 a.m. PT (oral presentation)

Title: Duvelisib (IPI-145), a phosphoinositide-3-kinase-δ,γ inhibitor, shows activity in patients with relapsed/refractory T-cell lymphoma

Abstract Number: 803

Lead Author: Steven Horwitz, M.D., Assistant Attending, Department of Medicine at Memorial Sloan-Kettering Cancer Center, New York, NY

Location: Moscone Center, West Building, 2005-2007-2018-2020

Infinity will also host a luncheon on Monday, December 8, 2014, from 12:00 p.m. – 1:30 p.m. PT in San Francisco to highlight duvelisib data being presented at the ASH 2014 Annual Meeting.

Infinity to Host Its Third Quarter Financial Results Conference Call/Webcast Today

As previously announced, Infinity will hold a conference call at 4:30 p.m. ET today to review its third quarter 2014 financial results, share an update on its business and provide an overview of the ASH abstracts referenced above. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 18542270. An archived version of the webcast will be available on Infinity's website for 30 days.

About the Development of Duvelisib for the Treatment of Blood Cancers

Infinity and AbbVie Inc. are developing duvelisib, an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The Class 1 PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes, or white blood cells, where they have distinct and predominantly non-overlapping roles in key cellular functions, including cell proliferation, cell differentiation, cell migration and activation. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies.

In 2013, Infinity launched the DUETTS^TM (Duvelisib Trials in Hematologic Malignancies) program, a worldwide investigation of duvelisib in blood cancers. As part of the DUETTS program, patient enrollment is ongoing in DYNAMO^TM, a Phase 2 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and DUO^TM, a Phase 3 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) (NCT02004522). DYNAMO+R^TM, a Phase 3 study of duvelisib in combination with rituximab in patients with previously treated follicular lymphoma (NCT02204982), is expected to start in 2014.

Additionally, a Phase 1 study of duvelisib in patients with advanced blood cancers is ongoing (NCT01476657).

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. 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: timing and type of presentations of data; the therapeutic potential of duvelisib and PI3K delta,gamma inhibition; and plans to conduct additional clinical trials of duvelisib. 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 Infinity's strategic collaboration with AbbVie will continue or 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 those 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 August 11, 2014, 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.