Epizyme, Inc., a clinical stage biopharmaceutical company, discovers, develops and plans to commercialize novel epigenetic therapies for cancer patients. The company engages in discovering and developing small molecule inhibitors of a class of enzymes known as histone methyltransferases, or HMTs. The company is also expanding its development efforts beyond HMTs and is developing small molecule inhibitors of other chromatin modifying proteins, or CMPs. The company’s major product candidate, tazemetostat, is a potent and selective inhibitor of the EZH2 HMT, an enzyme that plays an important role in various cancers. In its ongoing phase 1 clinical trial of tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma, or NHL, or in patients with advanced solid tumors, tazemetostat has shown meaningful clinical activity as a monotherapy, with an acceptable safety profile, in both NHL and in certain genetically-defined solid tumors. The company is evaluating tazemetostat in a phase 2 study in adults with relapsed or refractory NHL, and one phase 2 study in adults and one phase 1 study in children with certain genetically-defined solid tumors. In addition, in mid-2016, the company plans to initiate clinical trials of tazemetostat in combination with other therapies being used or investigated for the treatment of NHL. The company owns the global development and commercialization rights to tazemetostat outside of Japan. Eisai Co. Ltd, or Eisai, holds the rights to develop and commercialize tazemetostat in Japan, and holds a limited right of first negotiation for the rest of Asia. Tazemetostat is protected by the U.S. composition of matter patents, which are expected to expire in 2032. In February 2016, tazemetostat was granted orphan drug designation by the FDA for the treatment of malignant rhabdoid tumors, or MRT. The orphan drug designation applies to INI1-negative MRT, as well as SMARCA4-negative malignant rhabdoid tumor of the ovary, or MRTO, also known as small cell carcinoma of the ovary hypercalcemic type, or SCCOHT. The company has various additional programs in development, including a phase 1 clinical trial of pinometostat, an inhibitor of the DOT1L HMT, for the treatment of children with MLL-r, an acute leukemia with genetic alterations of the MLL gene. Under its collaboration with Celgene Corporation and Celgene RIVOT Ltd., an affiliate of Celgene Corporation, which the company collectively refers to as Celgene, the company owns commercialization rights to pinometostat in the United States and Celgene owns commercialization rights to pinometostat outside the United States. Along with Celgene, the company is also investigating in preclinical studies combinations of pinometostat with other targeted therapies for the treatment of adults with MLL-r. The company has additional small molecule HMT inhibitors that are being developed under its collaborations with Glaxo Group Limited (an affiliate of GlaxoSmithKline), or GSK, and Celgene. Under the company’s collaboration with GSK, GSK is developing small molecule inhibitors against three novel HMT targets, including protein arginine methyltransferase 5, or PRMT5. Under the company’s collaboration with Celgene, the company is developing small molecule inhibitors directed to three other HMT targets in addition to pinometostat. Under the collaboration, the company is responsible for all preclinical discovery work, as well as phase 1 clinical development for all three targets. Celgene has the option to license worldwide rights to inhibitors directed at two of the three targets, and the option to license ex-U.S. rights to inhibitors directed to the third target. The company retains rights to develop and commercialize the third target in the United States. Beyond its two clinical stage programs and the partnered programs with GSK and Celgene, the company has also identified five novel epigenetic targets for which the company is developing small molecule inhibitors in preclinical drug discovery. The company owns the global development and commercialization rights to these programs. Strategy The key elements of the company’s strategy are to ra
(EPZM:Consolidated Issue Listed on NASDAQ Global Select )
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