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Epizyme is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative personalized therapeutics for patients with genetically defined cancers. We systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found, and then design small molecule therapeutic product candidates to inhibit the oncogene. The clinical development plan for each of our therapeutic product candidates is directed towards patients with a particular genetically defined cancer. Our approach is part of a broader trend towards personalized therapeutics based on first identifying the underlying cause of a disease affecting specific patient populations, applying rational drug design tools to create a therapeutic to inhibit a molecular target in the identified disease pathway, and using a companion diagnostic to select the right patients for treatment. We have built a proprietary product platform that we use to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic. When Epizyme was founded, we recognized that the HMT class of enzymes might contain many potential oncogenes and presented the opportunity to discover, develop and commercialize multiple personalized therapeutics. We have prioritized 20 of the 96 HMTs as attractive targets for personalized therapeutics based on their oncogenic potential. Our two most advanced therapeutic product programs target the HMTs DOT1L (for the treatment of acute leukemias with genetic alterations of MLL) and EZH2 (for a genetically defined subtype of non-Hodgkin lymphoma and solid tumors including INI1-deficient tumors). We believe that our ongoing Phase 1 adult trial for EPZ-5676, targeting DOT1L, is the first clinical trial of an HMT inhibitor. In May 2014, we initiated a Phase 1b clinical trial for EPZ-5676 in pediatric patients with MLL-r leukemia, which is considered to be the last largely untreatable pediatric acute leukemia. We are also conducting a Phase 1/2 clinical trial of EPZ-6438, which is being developed for the treatment of non-Hodgkin lymphoma and solid tumors including INI1-deficient tumors such as synovial sarcoma and malignant rhabdoid tumors, or MRT. We were founded in 2007 and are led by a management team with extensive experience in the pharmaceutical industry. We have entered into therapeutic collaborations with Celgene, Eisai and GSK that have provided us with approximately $184 million in non-equity funding. As of June 30, 2014, we had $232.1 million in cash, cash equivalents and accounts receivables.
MEI Pharma (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. Our approach to building our pipeline is to license promising cancer agents and create value in programs through development and commercialization, or strategic partnerships, as appropriate. Our portfolio contains four clinical-stage drug candidates, including one candidate in an ongoing global registration trial and another candidate that is anticipated to advance into a registration trial this year. Our drug candidate pipeline includes: Pracinostat, an oral HDAC inhibitor that is in a Phase 3 pivotal study in combination with azacitidine for the treatment of acute myeloid leukemia. Pracinostat is also being evaluated in a clinical study in patients with myelodysplastic syndrome. Pracinostat is licensed to Helsinn Healthcare SA, a Swiss pharmaceutical corporation. ME-401, a selective oral inhibitor of phosphatidylinositol 3-kinase (“PI3K”) delta. ME-401 is anticipated to progress into a single-agent registration study in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. Voruciclib, an orally administered and selective cyclin-dependent kinase (“CDK”) inhibitor differentiated by its potent in vitro inhibition of CDK9 in addition to CDK6, 4 and 1. Initiation of a Phase I dose-escalation study in patients with relapsed and/or refractory B-cell malignancies after failure of prior standard therapies is scheduled to being in the second calendar quarter of 2018. ME-344, a novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate, has demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study. In preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death. It is currently being evaluated in an investigator-initiated study in combination with the VEGF inhibitor bevacizumab (marketed as Avastin®) in patients with HER2 negative breast cancer.
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