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Epizyme Announces Collaboration with Lymphoma Study Association to Evaluate Combination of Tazemetostat with R-CHOP in Front-line Non-Hodgkin Lymphoma

May 9, 2016 6:35 AM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that it has entered into a collaboration agreement with the Lymphoma Study Association (LYSA) to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in patients with diffuse large B-cell lymphoma (DLBCL). LYSA is a premier cooperative group in France dedicated to clinical and translational research for lymphoma, and is certified by the French National Cancer Institute. Under the agreement, the phase 1b/2 trial will be jointly conducted with the Lymphoma Academic Research Organisation (LYSARC), the operational arm of LYSA.

“We are pleased to have established a collaboration with LYSA and to conduct the first investigation of tazemetostat in the front-line treatment setting,” said Robert Bazemore, President and Chief Executive Officer, Epizyme. “This study agreement aligns with Epizyme’s strategy of partnering with world-class research organizations to accelerate our development programs. The planned combination trial builds on preclinical evidence of synergy between tazemetostat and R-CHOP, and will add to what we know about the utility of tazemetostat in patients with non-Hodgkin lymphoma.”

The open-label, clinical study will be sponsored by LYSARC and conducted at multiple sites in France. The study will enroll elderly, high-risk patients with newly diagnosed DLBCL, the most common form of non-Hodgkin lymphoma. Patients will receive tazemetostat in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), a standard treatment in newly diagnosed DLBCL. Epizyme and LYSARC jointly designed the study, which is expected to begin enrolling patients mid-year.

About the Tazemetostat Clinical Trial ProgramTazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing phase 2 programs in both non-Hodgkin lymphoma and certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma.

The company has announced plans to initiate additional clinical evaluations of tazemetostat in 2016, including a combination study with an immune checkpoint inhibitor in patients with NHL and a monotherapy study in adults with mesothelioma.

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 StatementsAny 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," "plans," "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 preclinical data and results from clinical trials will be predictive of the results of future trials, whether the Company’s collaborations will be successful, expectations for regulatory approvals, 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 our Form 10-K most recently filed with the SEC, 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.

Investors:
Rebecca Cohen, 617-401-0722
Epizyme, Inc.
Investor Relations and Corporate Communications
[email protected]
Media:
Michael Lampe, 484-575-5040
Scient Public Relations
[email protected]

Source: Epizyme, Inc.



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