Infinity Pharmaceuticals, Inc., a biopharmaceutical company, is engaged in the discovery, development, and delivery of medicines to people with difficult-to-treat diseases. Product Candidates IPI-145, the company’s main product candidate, is a potent, oral inhibitor of Class I delta and gamma isoforms of phosphoinositide-3-kinase, or PI3K, which the company is investigating in both hematologic malignancies and inflammatory diseases. 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 and PI3K-gamma isoforms are preferentially expressed in white blood cells, where they have distinct and mostly non-overlapping roles in immune cell development and function. The company has launched DUETTS, a worldwide investigation of IPI-145 in blood cancers. As part of the DUETTS program, the company is conducting DYNAMO, a Phase 2, open-label, single arm study evaluating the safety and efficacy of IPI-145 dosed at 25mg BID in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma (FL), marginal zone lymphoma and small lymphocytic lymphoma (or SLL), whose disease is refractory to radioimmunotherapy or both rituximab and chemotherapy. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IPI-145 for the potential treatment of FL, the most common subtype of iNHL. Also under the DUETTS program, the company is also conducting DUO, a randomized, monotherapy Phase 3 study of IPI-145 in approximately 300 patients with relapsed/refractory chronic lymphocytic leukemia (CLL). The company is also conducting an ongoing Phase 1, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in patients with advanced hematologic malignancies. The dose escalation portion of the trial is complete, with the maximum tolerated dose defined as 75 mg twice daily, or BID. In 2014, the company intends to initiate DYNAMO+R, a Phase 3 study of IPI-145 dosed at 25 mg BID in combination with rituximab in patients with relapsed/refractory iNHL, as well as a Phase 2 study of IPI-145 in treatment-naïve patients with iNHL. Inflammation and Autoimmune Diseases The company has completed a Phase 1, randomized, double-blind, placebo-controlled trial of IPI-145 in healthy adult subjects designed to support the development of IPI-145 in inflammatory and autoimmune diseases. The company is in the process of conducting a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety and pharmacokinetics of IPI-145 in patients with rheumatoid arthritis (RA), which the company refers to as the ASPIRA trial. The company is also conducting a Phase 2a randomized, double-blind, placebo-controlled trial of IPI-145 in patients with mild, allergic asthma. The company is also developing its second PI3K product candidate, a potent, oral inhibitor of PI3K-delta and gamma which the company refers to as IPI-443. Intellectual Property The company has five issued or allowed U.S. patents covering IPI-145 and/or other molecules related to its PI3K program, which expire on various dates between 2029 and 2031, excluding any patent term extension. In addition, the company has approximately 170 patents and patent applications pending worldwide related to its PI3K program. Research and Development The company’s research and development group is focusing on drug discovery, preclinical research, clinical trials and manufacturing technologies. The company’s research and development expenses for the year ended December 31, 2013, included approximately $99.8 million. Strategic Alliances In 2010, the company entered into a development and license agreement with Intellikine, Inc., or Intellikine, under which it obtained rights to discover, develop and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of PI3K, including IPI-145. Significant Events In September 2014, Infinity Pharmaceuticals, Inc. and AbbVie Inc. announced that they have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of patients with cancer.
infinity pharmaceuticals inc
780 Memorial Drive
Cambridge, MA 02139
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