Epizyme To Present New Data In Support Of Tazemetostat Clinical Development Program

Five posters comprising preclinical and clinical investigations of tazemetostat to be presented at American Association for Cancer Research Annual Meeting 2016

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, today announced that data from five accepted abstracts of tazemetostat (EPZ-6438), its clinical stage inhibitor of EZH2, will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2016 being held April 16-20 in New Orleans.

“We are pleased to be able to present these important new data, including mechanism of action and biomarker studies that continue to guide us in developing patient selection criteria for tazemetostat”

Tazemetostat is a first-in-class EZH2 inhibitor currently in phase 2 studies in advanced B-cell non-Hodgkin lymphoma (NHL) and certain genetically defined solid tumors. Among the data to be presented at the meeting are studies on the food effect and drug interaction characteristics of tazemetostat.

“We are pleased to be able to present these important new data, including mechanism of action and biomarker studies that continue to guide us in developing patient selection criteria for tazemetostat,” said Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. “Additionally, the clinical pharmacology studies being presented have helped to more fully inform the dosing of patients in our ongoing clinical programs.”

Planned Presentations:

Evidence of EZH2 Dependent and Independent Mechanisms of Tazemetostat Treatment Emergent Resistance in Models of Diffuse Large B Cell Lymphoma

Speaker: Carly T. Campbell, Epizyme, Inc.
Session Title: Mechanisms of Drug Resistance 1
Abstract Number: 312
Poster Number: 23
Presentation Time: Sunday, April 17, 2016, 1:00 PM - 5:00 PM

Development and Application of a 62-gene Panel for Assessment of Somatic Sequence and Structural Variants in Tumor DNA Derived from non-Hodgkin Lymphoma Patients Treated in a Phase 1 Clinical Trial with the EZH2 Inhibitor Tazemetostat

Speaker: Scott R. Daigle, Epizyme, Inc.
Session Title: Genomic Profiling of Cancers
Abstract Number: 137
Poster Number: 21
Presentation Time: Sunday, April 17, 2016, 1:00 PM - 5:00 PM

The Effect of Tazemetostat on CYP3A-mediated Metabolism of Midazolam in Patients with Solid Tumors

Speaker: Sherri Smith
Session Title: Phase I Clinical Trials in Progress
Abstract Number: CT029
Poster Number: 10
Presentation Time: Monday April 18, 2016 8:00 AM - 12:00 PM

The Effect of Food on the Pharmacokinetics of Tazemetostat in patients with Cancer

Speaker: Benjamin Suttle
Session Title: Phase I Clinical Trials in Progress
Abstract Number: CT031
Poster Number: 12
Presentation Time: Monday April 18, 2016 8:00 AM - 12:00 PM

The Effect of EPZ011989, an Enhancer of Zeste Homolog 2 Inhibitor, in Acute Myeloid Leukemia

Speaker: Sydney Fobare, Hendrix College, Conway, AR
Session Title: Histone Modifications and Chromatin Dynamics
Abstract Number: 4520
Poster Number: 7
Presentation Time: Wednesday, April 20, 8:00 AM – 12:00 PM

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-negative cancers such as malignant rhabdoid tumors and epithelioid sarcomas, certain SMARCA4-negative solid tumors, synovial sarcoma, and a range of other solid tumors.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and for patients with certain genetically defined 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 dysregulation 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 tazemetostat, including clinical trial information, can be found here.

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 chromatin modifying proteins (CMPs), such as histone methyltransferases or HMTs. CMPs 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 CMPs, 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 from a clinical trial 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-K filed with the SEC on March 9, 2016 and in the Company's 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 and should not be relied upon as representing the Company's views as of any date subsequent to 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.