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Epizyme and Celgene Advance EPZ-5676 DOT1L Inhibitor Clinical Program to Benefit Cancer Patients with Acute Leukemias, Achieving $25 Million Clinical Proof of Concept Milestone
Date:1/6/2014

eted enrollment and the adult MLL-r expansion stage that is now enrolling patients, at a medical conference in 2014."

Additionally, the European Medicines Agency's Committee for Orphan Medicinal Products recommended orphan drug designation for EPZ-5676 to the European Commission in December 2013. EPZ-5676 was granted orphan drug designation by the U.S. Food and Drug Administration in May 2013.

Including the Celgene POC milestone and the GSK development candidate milestone, Epizyme estimates a 2013 end-of-year cash and account receivables position of approximately $145 million versus previous guidance of an end-of-year cash position of more than $115 million.

Epizyme plans to have as many as five clinical proof of concept programs ongoing in 2014. For EPZ-5676, Epizyme's first-in-class DOT1L inhibitor, these include the ongoing adult MLL-r expansion stage, MLL-r in pediatric patients, and adult MLL-PTD patients. For EPZ-6438, Epizyme's first-in-class EZH2 inhibitor, these include adult non-Hodgkin lymphoma patients and also pediatric and young adult patients with synovial sarcomas, pending completion of the ongoing Phase 1 study.

About EPZ-5676 and Epizyme's Collaboration with Celgene
Epizyme is developing EPZ-5676, 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) or a partial tandem duplication (MLL-PTD). Due to these rearrangements, DOT1L is misregulated, resulting in the increased expression of genes causing leukemia.

Epizyme believes that EPZ-5676 was the first HMTi to enter human clinical development. Epizyme is currently conducting a two-stage Phase 1 study. The dose escalation stage has completed enrollment, and the adult MLL-r expansion stage is now enrolling patients. Additional information about this ongoing Phase 1 study can be found here:

SOURCE Epizyme, Inc.
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