Infinity Pharmaceuticals, Inc., a biopharmaceutical company, engages in the discovery, development, and delivery of medicines to people with difficult-to-treat diseases. 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. The company is conducting DUETTS (Duvelisib Trials in Hematologic Malignancies), a worldwide investigation of duvelisib 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 duvelisib dosed at 25 mg twice daily, or BID, in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma, marginal zone lymphoma and small lymphocytic lymphoma (SLL), whose disease is refractory to radioimmunotherapy or both rituximab and chemotherapy. The the U.S. Food and Drug Administration has granted orphan drug designation to duvelisib for the potential treatment of follicular lymphoma, the most common subtype of iNHL; DYNAMO+R, a Phase 3 randomized, placebo-controlled study evaluating duvelisib dosed at 25 mg BID in combination with rituximab, a monoclonal antibody treatment, compared to placebo plus rituximab in approximately 400 patients with previously treated follicular lymphoma; DUO, a Phase 3 randomized, monotherapy study evaluating duvelisib dosed at 25 mg BID compared to ofatumumab, a monoclonal antibody treatment, in approximately 300 patients with relapsed or refractory chronic lymphocytic leukemia, or CLL; A Phase 1b trial of duvelisib in combination with obinutuzumab, a monoclonal antibody treatment, in CLL patients whose disease has progressed following treatment with a Bruton’s tyrosine kinase, inhibitor; and A Phase 1b/2 clinical study of duvelisib in combination with obinutuzumab or rituximab in patients with previously untreated follicular lymphoma. The company is also conducting an ongoing Phase 1, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of duvelisib in patients with advanced hematologic malignancies. The company is pursuing duvelisib in oncology through a strategic collaboration with AbbVie Inc. In 2014, the company completed two Phase 2 studies of duvelisib in inflammation and concluded its investigation of duvelisib in this therapeutic area. In 2014, the company licensed rights to its fatty acid amide hydrolase, or FAAH program, to FAAH Pharma Inc., or FAAH Pharma, a company pursuing the clinical development of IPI-940 to investigate its potential to treat neuropathic pain. Research and Development The company’s research and development expenses for the year ended December 31, 2014, included approximately $143.6 million. Intellectual Property The company has 13 issued or allowed U.S. patents covering duvelisib and/or other molecules related to its PI3K programs, which expire on various dates between 2029 and 2033, excluding any patent term extension. In addition, it has approximately 200 patents and patent applications pending worldwide related to its PI3K program. Agreements The company has a development and license agreement with Intellikine, under which it obtained rights to discover, develop and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of PI3K, including duvelisib.
infinity pharmaceuticals inc
(INFI:Consolidated Issue Listed on NASDAQ Global Select )
780 Memorial Drive
Cambridge, MA 02139
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