Infinity Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering, developing, and delivering medicines to patients with difficult-to-treat diseases. Duvelisib The company’s most advanced product candidate is duvelisib, also known as IPI-145, an oral, dual-inhibitor of the delta and gamma isoforms of phosphoinositide-3-kinase (PI3K), which is being evaluated for the treatment of hematologic malignancies, or blood cancers. duvelisib is the inhibitor of PI3K-delta and gamma being investigated in Phase 3 clinical trials. The company is pursuing duvelisib in oncology through a strategic collaboration with AbbVie Inc. The company is conducting DUETTS (Duvelisib Trials in Hematologic Malignancies), a worldwide clinical investigation of duvelisib in blood cancers initially focusing on lymphoma and chronic lymphocytic leukemia (CLL). As part of the DUETTS program in lymphoma, the company is conducting DYNAMO, a Phase 2, open-label, single–arm monotherapy study evaluating the safety and efficacy of duvelisib dosed at 25 mg twice daily in 129 patients with indolent non-Hodgkin lymphoma (iNHL). The company completed enrollment in DYNAMO in September 2015 and expects to report topline data in the third quarter of 2016. Additional DUETTS clinical studies in lymphoma include CONTEMPO, BRAVURA, and FRESCO. CONTEMPO is a Phase 1b/2 clinical study of duvelisib in combination with obinutuzumab, a monoclonal antibody treatment, or rituximab in patients with previously untreated follicular lymphoma. The company expects to report initial data from CONTEMPO in the second half of 2016. BRAVURA is a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL designed to evaluate the safety and efficacy of duvelisib plus rituximab and bendamustine, a chemotherapy, compared to placebo plus rituximab and bendamustine in approximately 600 patients. The company requested advice from the U.S. Food and Drug Administration (FDA) to determine if BRAVURA, as designed, could serve as a confirmatory study if DYNAMO supports an accelerated approval. FRESCO is a Phase 2 randomized study in patients with relapsed or refractory follicular lymphoma that is designed to evaluate the safety and efficacy of duvelisib plus rituximab compared to rituximab plus a combination of chemotherapies referred to as ‘CHOP’ in approximately 230 patients. The chemotherapies included in CHOP are cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone. The primary endpoint of FRESCO is progression-free survival. DYNAMO+R, a Phase 3 randomized, placebo-controlled study evaluating duvelisib dosed at 25 mg BID in combination with rituximab compared to placebo plus rituximab in patients with previously treated follicular lymphoma has been identified for closure and is no longer enrolling patients. As part of the DUETTS investigation in CLL, the company is conducting DUO and SYNCHRONY. DUO is a randomized, Phase 3 monotherapy study designed to evaluate the safety and efficacy of duvelisib dosed at 25 mg BID compared to ofatumumab, a monoclonal antibody treatment, in 319 patients with relapsed or refractory CLL. SYNCHRONY is a Phase 1b trial of duvelisib in combination with obinutuzumab in CLL patients whose disease has progressed following treatment with a Bruton’s tyrosine kinase inhibitor. IPI-549 In 2015, the company expanded its pipeline to include IPI-549, an orally administered, selective PI3K-gamma inhibitor that the company intends to evaluate as a potential treatment in solid tumors. Preclinical data from studies investigating IPI-549 indicates that IPI-549 has the potential to heighten an anti-cancer response by targeting macrophages in the immune-suppressive tumor microenvironment and might have the potential to treat a range of solid tumors. IPI-549 has demonstrated dose-dependent, single-agent, anti-tumor activity in multiple solid tumor models, including mouse models of lung cancer, colon cancer and breast cancer. Based on the company’s preclinical data generated, the company has initiated a Phase 1 first-in-human study that includes a dose-escalation phase to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 as a monotherapy, as well as a dose-escalation phase evaluating IPI-549 in combination with a ‘checkpoint inhibitor’ therapy that targets a receptor in the human body called programmed death receptor 1. If supported by data from the initial portion of the study, a Phase 1b portion would investigate IPI-549 in patients with selected solid tumors, including non-small cell lung cancer and melanoma. Strategic Alliances The company has a development and license agreement with Intellikine, Inc., under which the company obtained rights to discover, develop, and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of PI3K, including duvelisib and IPI-549. In 2012, Intellikine, Inc. was acquired by Takeda Pharmaceutical Company Limited, acting through its Millennium business unit. Intellectual Property The company has eight issued or allowed U.S. patents related to its duvelisib program, which expire on various dates between 2029 and 2032, excluding any patent term extension. The company has three issued or allowed U.S. patents related to its PI3K gamma program, which expire on various dates between 2033 and 2034, excluding any patent term extension. In addition, the company has approximately 275 patents and patent applications pending worldwide related to its PI3K programs. Any patents that might issue from the company’s pending patent applications would expire between 2029 and 2035, excluding any patent term extension. Research and Development The company’s research and development expense was approximately $199.1 million for the year ended December 31, 2015.
infinity pharmaceuticals inc
784 Memorial Drive
Cambridge, MA 02139
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