(INFI) Enters into Master Clinical Supply Agreement with Roche

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has entered into a master clinical supply agreement with Roche under which Roche will supply Gazyva^TM (obinutuzumab) to Infinity for use in planned clinical studies to evaluate the combination of Gazyva and duvelisib (IPI-145), Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with hematologic malignancies, or blood cancers. The companies have also entered into a material transfer agreement under which Infinity is supplying Roche with duvelisib for use in Roche’s preclinical and translational research to evaluate the combination of duvelisib and Gazyva.

“We believe that duvelisib has the potential to be the best-in-class PI3K inhibitor and that Gazyva has the potential to be the best-in-class anti-CD20 therapy, so we are pleased to have entered into these agreements with Roche. Our ability to evaluate duvelisib in combination with Gazyva in multiple clinical studies is part of Infinity’s strategy to combine duvelisib with both current standards of care and novel, targeted therapies,” stated Julian Adams, president of research and development at Infinity. “We look forward to beginning clinical studies of duvelisib plus Gazyva, including the first study in indolent non-Hodgkin lymphoma evaluating Gazyva in combination with a PI3K inhibitor.”

In 2014, Infinity plans to initiate a Phase 1b/2 clinical study of duvelisib in combination with Gazyva or rituximab in patients with previously untreated indolent non-Hodgkin lymphoma (iNHL). Infinity also expects to initiate in 2014 a Phase 1b clinical study of duvelisib in combination with Gazyva in patients with chronic lymphocytic leukemia (CLL) whose disease has progressed following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. These studies are in addition to Infinity’s plans to initiate this year DYNAMO+R^TM, a global Phase 3 study evaluating duvelisib in combination with rituximab in patients with follicular lymphoma. Other global, registration-focused trials evaluating the safety and efficacy of duvelisib are ongoing, including DYNAMO^TM, a Phase 2 study in patients with iNHL, and DUO^TM, a Phase 3 study in patients with CLL.

Roche also plans to study duvelisib as part of its preclinical and translational efforts in hematology. These research efforts will be part of Roche’s ongoing efforts to further understand the therapeutic potential of Gazyva in combination with both approved medicines and experimental therapies.

“Duvelisib targets both PI3K-delta and PI3K-gamma, two proteins that play critical roles in the growth and survival of tumor cells,” stated Vito Palombella, Ph.D., chief scientific officer at Infinity. “We are pleased that Roche’s preclinical and translational science teams will be studying duvelisib in combination with Gazyva to understand how they may work together. We hope Roche’s research will contribute to our understanding of how duvelisib works in combination with other therapies, including Gazyva, as we seek to improve outcomes for patients.”

About the Development of Duvelisib for the Treatment of Blood Cancers

Infinity is 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 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.

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 relapsed 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: the supply of Gazyva by Roche; the therapeutic potential of duvelisib as a monotherapy and in combination with other therapies such as obinutuzumab; plans to initiate additional clinical trials with duvelisib; 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 initiate clinical trials 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 Roche will meet its obligations under the master clinical supply agreement, 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; the content and timing of decisions made by the U.S. Food and Drug Administration 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 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.