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Epizyme Progressing Well on Two Lead Pipeline Candidates
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We issued an updated research report on Epizyme, Inc. on Jun 23, 2017.
Currently, Epizyme is a development-stage biopharmaceutical company, focused on bringing novel epigenetic therapies for the treatment of cancer and other diseases to market.
Key candidates in Epizyme’s pipeline include tazemetostat (selective inhibitor of the EZH2 HMT) and pinometostat (an inhibitor of the DOT1L HMT).
We note that, Epizyme has made significant progress with its lead candidate, tazemetostat for the treatment of multiple types of hematological malignancies and genetically defined solid tumors. Tazemetostat is being evaluated as monotherapy in multiple phase II studies for indications such as relapsed or refractory non-Hodgkin lymphoma and in patients with certain molecularly defined solid tumors.
The company also announced positive interim efficacy data in June 2017 from the its ongoing phase II clinical trial of tazemetostat, as a single-agent treatment for relapsed or refractory patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) grouped by EZH2 mutational status. In fact, these interim data findings represent an important step forward for the tazemetostat program.
In May 2017, Epizyme, announced positive interim data on tazemetostat, from the epithelioid sarcoma cohort of its ongoing phase II study in adult patients with molecularly defined solid tumors. Further, the company announced that it conducted a positive meeting with the FDA and has identified a path to submission for accelerated approval of tazemetostat based on the 60-patient cohort from its phase II study. The company will target a new drug application (NDA) submission in 2018.
Again, in June, the FDA granted Orphan Drug designation to tazemetostat for the treatment of patients with soft tissue sarcoma (STS). This is an important milestone for Epizyme as it advances tazemetostat through clinical development.
Earlier, the FDA granted Fast Track designation to tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), either with type EZH2 or EZH2 activating mutations in April. We note that tazemetostat enjoys orphan drug designation in the U.S. for the treatment of malignant rhabdoid tumors (MRT). The orphan drug designation applies to INI1-negative MRT as well as SMARCA4-negative malignant rhabdoid tumor of ovary (MRTO).
Meanwhile, Epizyme’s second pipeline candidate, pinometostat, is being evaluated in a phase I dose-escalation study on pediatric patients suffering from an acute leukemia with genetic alterations of the MLL gene (MLL-r). It has an agreement with Celgene Corporation for the discovery, development and commercialization of small-molecule HMT inhibitors including pinometostat in the ex-U.S. markets.
Epizyme also has an agreement with Celgene for the discovery, development and commercialization of small-molecule HMT inhibitors including pinometostat in the ex-U.S. markets.
However, Epizyme’s products are still several years from commercialization while several big names like Glaxo, Novartis (NVS - Free Report) and Pfizer (PFE - Free Report) are already developing new epigenetic treatments for cancer.
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Epizyme Progressing Well on Two Lead Pipeline Candidates
We issued an updated research report on Epizyme, Inc. on Jun 23, 2017.
Currently, Epizyme is a development-stage biopharmaceutical company, focused on bringing novel epigenetic therapies for the treatment of cancer and other diseases to market.
Key candidates in Epizyme’s pipeline include tazemetostat (selective inhibitor of the EZH2 HMT) and pinometostat (an inhibitor of the DOT1L HMT).
We note that, Epizyme has made significant progress with its lead candidate, tazemetostat for the treatment of multiple types of hematological malignancies and genetically defined solid tumors. Tazemetostat is being evaluated as monotherapy in multiple phase II studies for indications such as relapsed or refractory non-Hodgkin lymphoma and in patients with certain molecularly defined solid tumors.
The company also announced positive interim efficacy data in June 2017 from the its ongoing phase II clinical trial of tazemetostat, as a single-agent treatment for relapsed or refractory patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) grouped by EZH2 mutational status. In fact, these interim data findings represent an important step forward for the tazemetostat program.
In May 2017, Epizyme, announced positive interim data on tazemetostat, from the epithelioid sarcoma cohort of its ongoing phase II study in adult patients with molecularly defined solid tumors. Further, the company announced that it conducted a positive meeting with the FDA and has identified a path to submission for accelerated approval of tazemetostat based on the 60-patient cohort from its phase II study. The company will target a new drug application (NDA) submission in 2018.
Again, in June, the FDA granted Orphan Drug designation to tazemetostat for the treatment of patients with soft tissue sarcoma (STS). This is an important milestone for Epizyme as it advances tazemetostat through clinical development.
Earlier, the FDA granted Fast Track designation to tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), either with type EZH2 or EZH2 activating mutations in April. We note that tazemetostat enjoys orphan drug designation in the U.S. for the treatment of malignant rhabdoid tumors (MRT). The orphan drug designation applies to INI1-negative MRT as well as SMARCA4-negative malignant rhabdoid tumor of ovary (MRTO).
Meanwhile, Epizyme’s second pipeline candidate, pinometostat, is being evaluated in a phase I dose-escalation study on pediatric patients suffering from an acute leukemia with genetic alterations of the MLL gene (MLL-r). It has an agreement with Celgene Corporation for the discovery, development and commercialization of small-molecule HMT inhibitors including pinometostat in the ex-U.S. markets.
Epizyme also has an agreement with Celgene for the discovery, development and commercialization of small-molecule HMT inhibitors including pinometostat in the ex-U.S. markets.
However, Epizyme’s products are still several years from commercialization while several big names like Glaxo, Novartis (NVS - Free Report) and Pfizer (PFE - Free Report) are already developing new epigenetic treatments for cancer.
The Best & Worst of Zacks
Today you are invited to download the full, up-to-the-minute list of 220 Zacks Rank #1 "Strong Buys" free of charge. From 1988 through 2015 this list has averaged a stellar gain of +25% per year. Plus, you may download 220 Zacks Rank #5 "Strong Sells." Even though this list holds many stocks that seem to be solid, it has historically performed 6X worse than the market. See these critical buys and sells free >>