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Last $15.95 USD
Change Today +0.52 / 3.37%
Volume 159.6K
EPZM On Other Exchanges
As of 8:10 PM 11/25/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

400 Technology Square

4th Floor

Cambridge, MA 02139

United States

Phone: 617-229-5872

Fax: 617-349-0707

Epizyme, Inc., a clinical stage biopharmaceutical company, discovers, develops and plans to commercialize novel epigenetic therapies for cancer patients. The company has built a proprietary product platform that it uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases (HMTs). HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations could result in changes to the activity of HMTs, making them oncogenic. The company’s therapeutic strategy is to treat the underlying causes of specific cancers by blocking the misregulated activity of oncogenic HMTs. HMTs regulate gene expression by adding marks, called methyl groups, to specific locations on the proteins of human chromosomes, or histones, a process known as methylation. EPZ-6438—EZH2 Inhibitor The company is developing EPZ-6438 as an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients and for the treatment of patients with INI1-deficient solid tumors, such as synovial sarcoma, a soft tissue sarcoma, and malignant rhabdoid tumor, a primarily pediatric cancer with high unmet medical need. The company is conducting a Phase 1/2 clinical trial of EPZ-6438 in patients with relapsed or refractory B-cell lymphoma or advanced solid tumors. In 2014, the company and its collaboration partner Eisai Co. Ltd. (Eisai) completed enrollment in the dose escalation portion of this Phase 1/2 clinical trial and disclosed the first clinical responses to treatment with EPZ-6438 from this ongoing Phase 1/2 clinical trial. In March 2015, the company reacquired global rights to develop, manufacture, and commercialize EPZ-6438 outside of Japan from Eisai. In March 2015, the company entered into an amended and restated collaboration and license agreement with Eisai, under which the company reacquired worldwide rights, excluding Japan, to its EZH2 program, including EPZ-6438. The company plans to launch the Phase 2 portion of its EPZ-6438 trial in non-Hodgkin B-cell lymphoma in the second quarter of 2015 in the European Union. In the second half of 2015, the company plans to initiate a Phase 1 trial of EPZ-6438 for the treatment of INI1-deficient tumors, such as MRT, in pediatric patients and a Phase 2 trial of EPZ-6438 for the treatment of INI1-deficient tumors, such as synovial sarcoma, in adult patients. The company is working with Roche to develop an in vitro based diagnostic for use as a companion diagnostic with EPZ-6438 for non-Hodgkin lymphoma patients with EZH2 point mutations and plan to use this diagnostic in the prospective screening of patients for stratification in the Phase 2 portion of its EPZ-6438 clinical trial. The agreement with Roche calls for the development of a diagnostic to test for the presence of an oncogenic point mutation in EZH2. Under the agreement, Roche would have the right to commercialize the companion diagnostic with EPZ-6438. The company anticipates that the company and Roche would coordinate its marketing and sales activities for EPZ-6438 and the companion diagnostic. EPZ-5676—DOT1L Inhibitor The company is developing EPZ-5676 as an intravenously administered small molecule inhibitor of DOT1L for the treatment of acute leukemias with alterations in the MLL gene, specifically rearrangements of MLL as a consequence of chromosomal translocation, referred to as MLL-r, which includes partial tandem duplications of the MLL gene, referred to as MLL-PTD. The company invented EPZ-5676 using its proprietary product platform and initiated a Phase 1 clinical trial of this product candidate in 2012. In 2014, the company initiated a Phase 1 trial of EPZ-5676 in pediatric patients with MLL-r. This Phase 1 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of EPZ-5676 in patients between the ages of 3 months and 18 years. This trial is also designed to provide a preliminary assessment of efficacy. The company retains all U.S. rights to EPZ-5676. It has granted Celgene an exclusive license to EPZ-5676 outside of the United States


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