CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, announced today that data from the ongoing phase 1 study of tazemetostat (EPZ-6438) will be presented during the American Society of Hematology Meeting being held December 5 – 8 in Orlando, Florida. Tazemetostat is a first-in-class EZH2 inhibitor that is currently being studied in relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL) and solid tumors. The company will also present an update on its phase 1 study of pinometostat (EPZ-5676) in adult patients with MLL-r acute leukemia and a preliminary report on its phase 1 study of pinometostat in children with MLL-r acute leukemia.
“Tazemetostat has demonstrated significant potential in early clinical testing in patients with NHL,” said Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. “Based on the clinical activity and acceptable safety profile observed with tazemetostat, we believe there is potential for tazemetostat to treat both late-stage NHL as a monotherapy and also earlier-stage disease as a combination therapy. We are continuing to advance tazemetostat in a registration-supporting Phase 2 study in five subtypes of relapsed or refractory NHL, and look forward to beginning investigation of tazemetostat as a combination agent in patients with NHL in the first half of 2016.”
Planned presentations:
Phase 1 Study of Tazemetostat (EPZ-6438), an Inhibitor of Enhancer of
Zeste-Homolog 2 (EZH2): Preliminary Safety and Activity in Relapsed or
Refractory Non-Hodgkin Lymphoma (NHL) Patients
Speaker: Vincent
Ribrag, M.D., Institut Gustave Roussy, Villejuif, France.
Session
title: 624. Lymphoma: Therapy with Biologic Agents, excluding
Pre-Clinical Models: Biologic Agents in B Cell Lymphoma (Oral Session)
Presentation
time: Monday, December 7, 2015 at 8:00am ET
A Phase 1 Study of the DOT1L Inhibitor Pinometostat, EPZ-5676, in
Advanced Leukemia: Safety, Activity and Evidence of Target Inhibition
Presenter:
Eytan M. Stein, M.D., Memorial Sloan Kettering Cancer Center
Session
title: Poster Session II
Presentation time: Sunday,
December 6, 2015 from 6:00 – 8:00pm ET
Preliminary Report of the Phase 1 Study of the DOT1L Inhibitor
Pinometostat (EPZ 5676) in Children with MLL-r Acute Leukemia: Safety,
Exposure and Evidence of Target Inhibition
Presenter: Neerave
Shukla, M.D., Memorial Sloan Kettering Cancer Center
Session
title: Poster Session III
Presentation time: Monday,
December 7, 2015 from 6:00 – 8:00pm ET
About EZH2 in Cancer
EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include Non-Hodgkin Lymphoma, INI1-deficient cancers such as malignant rhabdoid tumors, epithelioid sarcomas and synovial sarcoma; and a range of other solid tumors.
About Tazemetostat
Epizyme is developing tazemetostat for the treatment of Non-Hodgkin Lymphoma patients and patients with INI1-deficient solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.
Additional information about this program, including clinical trial information, may be found here: https://clinicaltrials.gov/ct2/show/NCT01897571
About Pinometostat
Epizyme is developing pinometostat, a small molecule inhibitor of DOT1L created with Epizyme's proprietary product platform, for the treatment of patients with acute leukemia in which the MLL gene is rearranged due to a chromosomal translocation (MLL-r). Due to these rearrangements, DOT1L is misregulated, resulting in the increased expression of genes causing leukemia. Pinometostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-5676.
Epizyme believes that pinometostat was the first HMT inhibitor to enter
human clinical development. Epizyme initiated a phase 1b study of
pinometostat in pediatric patients with MLL-r in May 2014. Additional
information about this ongoing phase 1 study can be found here:
https://clinicaltrials.gov/ct2/show/NCT02141828.
Pinometostat has been granted orphan drug designation for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) by the Food and Drug Administration in the U.S. and by the European Commission in Europe.
Epizyme retains all U.S. rights to pinometostat and has granted Celgene an exclusive license to pinometostat outside of the U.S.
About Epizyme, Inc.
Epizyme, Inc. is a clinical stage biopharmaceutical company creating novel epigenetic therapeutics for cancer patients. Epizyme has built a proprietary product platform that the Company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic (cancer-causing). By focusing on the genetic drivers of cancers, Epizyme's targeted science seeks to match the right medicines with the right patients.
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies or expansion of ongoing clinical studies; availability and timing of data from ongoing clinical studies; whether interim results will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products; development progress of the Company's companion diagnostics, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates or companion diagnostics; and other factors discussed in the "Risk Factors" section of the company's Form 10-Q filed with the SEC on August 6, 2015, and in our other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
