Infinity Pharmaceuticals Inc. Announces Presentations On Investigational Development Candidates, Duvelisib And IPI-549, At Upcoming European Hematology Association And ASCO Meetings

CAMBRIDGE, Mass., May 19, 2016 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that new data will be presented for duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, at the 21^st Congress of the European Hematology Association (EHA) taking place from June 9 12, 2016, in Copenhagen. At the meeting, preliminary data from CONTEMPO, a Phase 1b/2 study evaluating duvelisib in combination with rituximab or obinutuzmab in treatment-naïve follicular lymphoma patients, will be presented in a poster session. Duvelisib is the only dual inhibitor of PI3K-delta,gamma in Phase 3 clinical development and is in registration-focused studies in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) and relapsed/refractory chronic lymphocytic leukemia (CLL). Infinity and AbbVie are jointly developing duvelisib in oncology.

Additionally, posters reviewing ongoing clinical studies of duvelisib and IPI-549, Infinity's investigational immuno-oncology development candidate that selectively inhibits PI3K-gamma, will be presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from June 3 7, 2016.

Presentations and publications are listed below. All abstracts are available on the conference websites.

EHA 2016
Friday, June 10, 2016, 11:15 a.m. ET 12:45 p.m. ET (5:15 p.m. 6:45 p.m. CEST) (poster presentation)
Title: Preliminary Safety, Pharmacokinetics, and Pharmacodynamics of Duvelisib Plus Rituximab or Obinutuzumab in Patients with Previously Untreated CD20+ Follicular Lymphoma
Abstract Number: P319
Lead Author:Carla Casulo, M.D., James P. Wilmont Cancer Center Strong Memorial Hospital, University of Rochester
Location: Hall H

ASCO 2016
Sunday, June 5, 2016, 9:00 a.m. 12:30 p.m. ET (8:00 a.m. 11:30 a.m. CT) (poster session)
Title:  IPI-549-01-A phase 1/1b First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Abstract Number: TPS3111
Lead Author: Anthony W. Tolcher, M.D, Director of Clinical Research, South Texas Accelerated Research Therapeutics (START)
Location: Hall A

Monday, June 6, 2016, 9:00 a.m. 12:30 p.m. ET (8:00 a.m. 11:30 a.m. CT) (poster session)
Title: FRESCO: A Phase 2, Randomized Study of Duvelisib Plus Rituximab vs R-CHOP in Patients with Relapsed/Refractory Follicular Lymphoma Who Have Progressed within 24 Months of Receiving an Alkylator-Based Chemotherapy Regimen.
Abstract Number: TPS7578
Lead Author:Nathan Fowler, M.D., Associate Professor at the Department of Lymphoma/Myeloma, University of Texas, MD Anderson Cancer Center
Location: Hall A

ASCO Publication Only
Title:  Preliminary Safety, Pharmacokinetics, and Pharmacodynamics of Duvelisib Plus Rituximab or Obinutuzumab in Patients with Previously Untreated CD20+ Follicular Lymphoma
Abstract Number: #e19052
Lead Author: Carla Casulo, M.D., James P. Wilmont Cancer Center Strong Memorial Hospital, University of Rochester 

About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. ^1-3AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and developing duvelisib in various cancer types.

Duvelisib is being evaluated in several studies, including a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma⁴, a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma⁵ and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia⁶. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune-suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

These are investigational drugs being studied for indications that have not been approved by Regulatory Agencies. Safety and efficacy have not been established in unapproved indications.

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: plans to initiate or advance duvelisib studies in 2016; plans to submit regulatory applications for duvelisib in 2016 and launch duvelisib in 2017; the timing and type of plans to report clinical data; the therapeutic potential of PI3K inhibition and duvelisib and IPI-549; achievement of milestones under its collaboration with AbbVie; and its ability to execute on its strategic plans. 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, complete enrollment, initiate clinical studies, or submit regulatory filings 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 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; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; 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 or intends to develop 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 4, 2016, 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 Winkler D.G., Faia K.L., DiNitto J.P. et al. (2013) PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 20: 1-11.
² Reif K et al.Cutting Edge: Differential Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
³ Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.
⁴ www.clinicaltrials.gov, NCT01882803
⁵ www.clinicaltrials.gov, NCT02576275
⁶ www.clinicaltrials.gov, NCT02004522

Contacts:
Jaren Irene Madden, Senior Director,
Investor Relations and Corporate Communications
617-453-1336 or Jaren.Madden@infi.com

Christi Waarich
Senior Manager, Investor Relations
617-453-1363 or Christi.Waarich@infi.com

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SOURCE Infinity Pharmaceuticals, Inc.