"This collaboration reflects Epizyme's strategy to enhance our development programs through impactful partnerships," said
As part of the CRADA for tazemetostat, CTEP will collaborate with
Under the second CRADA, the safety and efficacy of pinometostat will be evaluated in patients with acute leukemias. Initial studies will evaluate the combination of pinometostat with standard-of-care therapies or targeted agents in acute myeloid leukemia, acute lymphoid leukemia, or mixed lineage leukemia characterized by a rearrangement in the mixed lineage leukemia gene (MLL-r). Preclinical studies of pinometostat in MLL-r cell line models have shown synergy with chemotherapies, including acute leukemia standard-of-care agents and select targeted therapies.
As part of both agreements, additional clinical trials will be considered. NCI will predominantly fund the studies and manage study operations.
About the Tazemetostat Clinical Program
Tazemetostat, a first-in-class EZH2 inhibitor, is being evaluated as a monotherapy and in combination with other agents in multiple cancer indications. Phase 2 studies of tazemetostat as a monotherapy are currently ongoing in patients with non-Hodgkin lymphoma; in adults and children with certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma; and in patients with mesothelioma characterized by BAP1 loss-of-function. Tazemetostat has been granted orphan drug status by the
Additionally, tazemetostat is being evaluated in two combination studies in patients with diffuse large B-cell lymphoma (DLBCL). A first-line Phase 1b/2 trial of tazemetostat in combination with R-CHOP, an immunochemotherapy regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, is being conducted as part of Epizyme's collaboration with the
Pinometostat, a small molecule inhibitor of DOT1L, is under clinical evaluation for the treatment of children with acute leukemias, including a genetically defined leukemia characterized by MLL-r. Pinometostat is being developed in collaboration with Celgene.
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 and in the 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; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; expectations for regulatory approvals to conduct trials or to market products; whether the Company's cash resources will be sufficient to fund 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; and other factors discussed in the "Risk Factors" section of the Company's most recent Form 10-Q filed with the SEC 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.
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