Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that new data for IPI-145, the company’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at the American Society of Hematology (ASH) 2013 Annual Meeting, which is being held December 7-10 in New Orleans, Louisiana. Key results to be presented during the meeting include updated data from Infinity’s Phase 1 study evaluating the safety, clinical activity and pharmacokinetics of IPI-145 in patients with chronic lymphocytic leukemia (CLL). Updated topline Phase 1 data on the activity of IPI-145 in patients with indolent non-Hodgkin lymphoma (iNHL) and T-cell lymphoma will also be reported. Additionally, the company will present preclinical and/or translational data supporting the potential of IPI-145 across a range of hematologic malignancies, including iNHL, CLL, diffuse large B‐cell lymphoma (DLBCL) and T‐cell acute lymphoblastic leukemia (ALL). Presentations of IPI-145 at ASH 2013 include the following: Saturday, December 7, 2013, 5:30 p.m. – 7:30 p.m. CT (poster presentations) Title: Treatment with the potent PI3K‐delta,gamma inhibitor IPI‐145 is associated with rapid decreases in specific cytokines, chemokines and matrix metalloproteinases in the serum of patients with chronic lymphocytic leukemia and indolent non‐Hodgkin lymphoma Presenter: Howard M. Stern, M.D., Ph.D., Infinity Pharmaceuticals, Cambridge, MA Location: Hall E Title: The potent PI3K‐delta,gamma inhibitor, IPI‐145, exhibits differential activity in diffuse large B‐cell lymphoma (DLBCL) cell lines Presenter: Jeffery L. Kutok, M.D., Ph.D., Infinity Pharmaceuticals, Cambridge, MA Location: Hall G Title: The potent PI3K‐delta,gamma inhibitor, IPI‐145, exhibits preclinical activity in murine and human T‐cell acute lymphoblastic leukemia Presenter: Xiaoyan Huang, M.D., MSc., Department of Hematopathology, MD Anderson Cancer Center, Houston, TX Location: Hall E Sunday, December 8, 2013, 6:00 p.m. – 8:00 p.m. CT (poster presentation) Title: Inhibition of PI3K-delta and -gamma isoforms by IPI-145 in chronic lymphocytic leukemia overcomes signals from PI3K/AKT/S6 pathway and promotes apoptosis Presenter: Kumudha Balakrishnan, Ph.D., Department of Experimental Therapeutics, MD Anderson Cancer Center, Houston, TX Location: Hall E Monday, December 9, 2013, 4:30 p.m. – 6:00 p.m. CT (oral presentation at 5:30 p.m. CT) Title: Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-delta,gamma, in patients with chronic lymphocytic leukemia Presenter: Ian W. Flinn, M.D., Sarah Cannon Research Institute, Nashville, TN Location: Room 295-296 Third Quarter Financial Results Conference Call/Webcast Reminder As previously announced, Infinity will hold a conference call at 4:30 p.m. ET today to review its third quarter 2013 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 34959052. An archived version of the webcast will be available on Infinity's website for 30 days. ASH Investor Reception and Webcast Infinity will host a reception on Sunday, December 8, 2013, from 11:00 a.m. to 12:30 p.m. CT (12:00 p.m. to 1:30 p.m. ET) in New Orleans, Louisiana, to review its PI3K-delta,gamma program in hematologic malignancies and discuss the IPI-145 data being presented at the ASH 2013 Annual Meeting. The event will be webcast 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. About the Development of IPI-145 for the Treatment of Blood Cancers Infinity is developing IPI-145, 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 PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly 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 as well as inflammatory diseases.
Infinity is currently enrolling patients with refractory indolent non-Hodgkin lymphoma (iNHL) in a Phase 2 study to evaluate the safety and efficacy of IPI-145 (ClinicalTrials.gov Identifier NCT01882803). An investigator-sponsored Phase 1b, open-label study of IPI-145 in patients with B-cell NHL, CLL and T-cell lymphoma in combination with rituximab (a monoclonal antibody therapy), bendamustine (a chemotherapy) or both rituximab and bendamustine is also open for enrollment ( NCT01871675). Additionally, a Phase 1 study of IPI-145 in patients with advanced hematologic malignancies is ongoing ( NCT01476657). Infinity plans to begin enrolling a Phase 3 study of IPI-145 in patients with relapsed/refractory CLL by the end of 2013.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: the timing and type of data to be presented at the American Society of Hematology 2013 Annual Meeting; plans to initiate additional clinical trials; its ability to execute on its strategic plans; and the therapeutic potential of PI3K inhibition and IPI-145. 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 initiate clinical trials, enroll patients, or 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; cash requirements and unplanned cash expenditures; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing its product candidates; adverse economic and market conditions, 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 August 8, 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.