Infinity Pharmaceuticals, Inc. recently provided an update on the commercial overview and clinical development program for duvelisib (IPI-145), an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells. The company also presented its lead immuno-oncology drug candidate, IPI-549, during its Research and Development (R&D) Day that took place in New York on October 6.

During the presentations, the company reviewed its expected timelines for the clinical development program and planned commercialization of duvelisib. Infinity recently revealed the enrollment of the 120^th patient in its DYNAMO Phase 2 clinical trial in refractory indolent non-Hodgkin lymphoma (iNHL) patients, as well as positive topline results from this trial which are expected to be disclosed during the third trimester of 2016. The company also reviewed the IPI-549 results presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference and debated the scheduled Phase 1 clinical trial for IPI-549 in solid tumors.

“We are entering into an exciting time for Infinity,” stated Julian Adams, the company’s president, research and development. “During our R&D Day, we will provide a thorough review of our duvelisib program, including preclinical and clinical data that support our registration focused trials in iNHL and CLL, DYNAMO and DUO, respectively, and outline our clinical development strategy to further differentiate duvelisib. We are extremely pleased to have some of the top experts in leukemia, lymphoma and immuno-oncology to provide the physician’s perspective based on their knowledge and experience, and we also look forward to sharing the innovative science that led to IPI-549.”

The company also announced that William (Bill) Bertrand is the new executive vice president and Infinity’s general counsel. This role is effective on October 19^th , reporting to Adelene Perkins, Infinity’s president, chair and chief executive officer. “Bill has tremendous experience along the entire biotechnology value chain from preclinical through commercialization as the first and only general counsel of MedImmune and most recently, as the chief operating officer and general manager of Salix prior to its acquisition by Valeant this summer,” stated Perkins. “Bill will serve on Infinity’s senior executive leadership team and play an important role in helping us build the company and bring duvelisib to patients.”

“During today’s R&D day, we look forward to sharing our vision for Infinity as well as providing an update on our development programs. With the recent completion of patient enrollment in DYNAMO, our ongoing duvelisib trials, the start of important new trials later this year, and the expansion of our pipeline with IPI-549, we are taking key steps toward our goal of delivering important new medicines to patients that could make a meaningful difference in their lives,” Perkins added.

More information can be found at: www.infi.com.

R&D Day Highlights

• Duvelisib: In September, the company announced that the 120^th patient had been enrolled in DYNAMO, a Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 as a monotherapy in subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT. The study primary outcome measure is the overall response rate (ORR) in all subjects during treatment with IPI-145 based on standard response. Infinity expects to disclose the results of this trial during the third trimester of 2016.
• Infinity expects DUO^™ enrollment to be completed by the end of the year. DUO is a Phase 3 clinical trial to examine the efficacy of IPI-145 monotherapy versus ofatumumab mono therapy in some 300 subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study primary outcome is progression-free survival (PFS), from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
• Infinity anticipates that AbbVie will start the first clinical trial of duvelisib and venetoclax, a selective first-in-class BCL-2 inhibitor, by the end of the year. This will be a Phase 1b/2 study of duvelisib and venetoclax to assess the activity and safety of the combination across a range of hematologic malignancies.
• Infinity also announced that it plans to begin in the fourth trimester of 2015 BRAVURA, a Phase 3, placebo-controlled, double-blind clinical trial in patients with relapsed iNHL. The study will evaluate the efficacy and safety of duvelisib combined with rituximab and bendamustine (RB) in comparison to placebo combined with RB in about 600 patients. The study primary outcome is progression-free survival.
• The company also announced it is planning to begin FRESCO, a Phase 2 clinical trial in patients with relapsed/refractory Follicular Lymphoma. The study will assess the efficacy and safety of duvelisib in combination with rituximab versus rituximab plus chemotherapy in about 200 patients. The study primary outcome is progression-free survival.
• IPI-549: IPI-549 is an orally administered immune-oncology development candidate that selectively inhibits phosphoinoside-3-kinase gamma (PI3K-gamma) for the treatment of solid tumors. Preclinical data demonstrating the potential of IPI-549 to disrupt the immune-suppressive tumor microenvironment and enable a heightened anti-tumor immune response supports further development in solid tumors including murine models of lung, colon and breast cancer.

Infinity expects to file an Investigational New Drug (IND) Application for IPI-549 by the end of 2015. The first Phase 1 clinical study of IPI-549 is expected to begin in early 2016. This study will explore IPI-549’s activity and safety and will include a dose escalation study period to evaluate the drug agent as a monotherapy, and also a dose-escalation study period to evaluate IPI-549 combined with anti–PD-1 antibody therapy. An expansion study period is scheduled in patients with selected solid tumors, such as melanoma and non-small cell lung cancer (NSCLC).

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