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Infinity Reports Preclinical Data for Duvelisib Demonstrating Synergy with Standard-of-Care Therapies and Emerging Agents in Development for the Treatment of Hematologic Malignancies

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Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced new preclinical data for duvelisib (IPI-145), an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. In vitro studies demonstrated synergy with standard-of-care therapies and emerging agents in development for hematologic malignancies, including duvelisib in combination with venetoclax, in combination with ibrutinib and in combination with dexamethasone. Additionally, in preclinical studies with each of these three combinations, significant inhibition of lymphoma tumor growth was observed compared to each of these agents alone. These data will be presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. on Sunday, May 31, 2015.

“Targeted combinations have the potential to further improve treatment options for patients, and Infinity’s translational research team continues to collaborate with AbbVie, our global partner for duvelisib in oncology, to identify therapies that may be synergistic with duvelisib,” stated Vito Palombella, Infinity’s chief scientific officer. “This research supports further development of duvelisib in combination with approved and investigational medicines, including venetoclax.”

“Additionally, preclinical research evaluating the activity of PI3K-delta isoform selective inhibitors and PI3K-gamma isoform selective inhibitors together shows that inhibiting both isoforms leads to greater tumor growth inhibition than either isoform alone, suggesting dual inhibition of PI3K-delta and PI3K-gamma has complementary effects on malignant B-cell growth and survival in these preclinical models,” Dr. Palombella continued.

Preclinical and Translational Combination Data for Duvelisib (Abstract #8559)

New preclinical and translational research conducted in collaboration with researchers at AbbVie will be reported at ASCO 2015 on Sunday, May 31, from 8:00 a.m. – 11:30 a.m. CDT (9:00 a.m. – 12:30 p.m. EDT) in a poster presentation, “High throughput in vitro combination sensitivity screen in hematologic malignancies with the phosphoinositide-3-kinase (PI3K)-delta,gamma inhibitor, duvelisib.”

As part of Infinity and AbbVie’s ongoing joint efforts to identify compounds synergistic with duvelisib, researchers conducted an in vitro high-throughput combination screen using a panel of cell lines and various drug combinations. In vitro synergy was observed with standard-of-care therapies and emerging agents in development for hematologic malignancies, including duvelisib in combination with venetoclax, in combination with ibrutinib and in combination with dexamethasone.

Additionally, in preclinical human xenograft studies with each of these three combinations, significant inhibition of lymphoma tumor growth was observed compared to each of these agents alone. These data support the use of duvelisib as part of combination therapy and provide additional rationale for the first clinical study of duvelisib in combination with venetoclax.

Researchers also evaluated the impact of dual inhibition of PI3K-delta and PI3K-gamma using isoform-selective inhibitors in preclinical models. Combined inhibition of PI3K-delta and PI3K-gamma led to greater tumor growth inhibition compared to the inhibition of either PI3K isoform alone, suggesting that dual inhibition of PI3K-delta and PI3K-gamma with duvelisib has complementary effects on malignant B-cell growth and survival in these preclinical models.

Additional Duvelisib Presentations at ASCO 2015

In total, four duvelisib presentations will take place on Sunday, May 31, 2015, during a poster session from 8:00 a.m. to 11:30 a.m. CDT in South Hall A at McCormick Place. In addition to the preclinical data reported today, duvelisib presentations at ASCO 2015 will include the following:

  • Phase 1 data describing the clinical activity and pharmacodynamics effects of duvelisib in a cohort of treatment-na”ive patients with chronic lymphocytic leukemia (CLL) (Abstract #7074)
  • Translational data providing insight into the mechanism by which duvelisib disrupts communication between tumor cells and the supporting microenvironment in CLL (Abstract #7072)
  • A “trials in progress” poster highlighting SYNCHRONY, a Phase 1b study of duvelisib and obinutuzumab in CLL patients whose disease is refractory to or has relapsed while receiving a BTK inhibitor (Abstract #TPS7100)

About Duvelisib

Duvelisib is a dual, oral inhibitor of phosophoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is being jointly developed by Infinity Pharmaceuticals, Inc. and AbbVie Inc. The PI3K pathway is known to play a critical role in regulating the growth and survival of certain types of blood cancers. Duvelisib is designed to block the growth and survival of tumor cells by inhibiting PI3K-delta and PI3K-gamma signaling. The investigational agent is being evaluated in registration-focused studies, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUOTM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

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 presentation of preclinical and translational data; and the therapeutic potential of PI3K inhibition and duvelisib, alone or in combination with other agents. 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 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, 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 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 6, 2015, 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.

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