Epizyme, Inc. (EPZM)

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Epizyme, Inc. (EPZM)

32nd Annual JPMorgan Healthcare Conference Call

January 16, 2014 3:00 PM ET


Robert J. Gould Ph.D. – President and CEO


Unidentified Analyst

Good morning everyone, thank you for joining us. It is my pleasure to introduce Epizyme. Speaking on behalf of Epizyme will be CEO, Dr. Robert Gould. I just like to remind everyone that the breakout session will take place in the Olympic Room which is just down the hall and right around the corner. So with that turn it over to you.

Robert J. Gould

Thank you very much. It is my pleasure to present to you today the progress that Epizyme has made in the last year and hope we anticipate looking forward to in 2014. Epizyme is a biopharmaceutical company creating personalized therapeutics for patients with genetically-defined cancers. We create proprietary first-in-class small molecule inhibitors of a number of a class of enzymes called histone methyltransferases. This family of enzymes comprises 96 members and these enzymes control gene expression through a phenomenon called Epigenetics.

When these enzymes are misregulated or genetically altered they can be the direct drivers of a variety of both solid and hematologic malignancies as well as other diseases. We currently have two programs that are in clinical development for these genetically-defined cancers. The first molecule goes by the name EPZ-5676 and it is an inhibitor of an enzyme called DOT1L, one of the histone methyltransferases. The second program that’s in clinical development is a net compound EPZ-6438, which is an inhibitor of an enzyme called EZH2. We are very excited that in the last year in 2013, we were able to demonstrate objective responses in our first clinical trial in the Phase I dose escalation study. These two programs are generated by a product platform that we put together a number of years ago, that creates a pipeline of novel personalized therapeutic programs and continues to be a productive source of novel chemical entities for us as inhibitors of these enzymes. All of the intellectual property at Epizyme is generated in-house and our earliest composition of matter patents expire in 2032. We’ve developed therapeutic collaborations with Celgene, Eisai and GSK over the last few years.

And importantly companion diagnostic collaboration with Abbott and Roche to facilitate the identification of patients with the genetic alterations that are driving their diseases. In 2013 we completed enrollment of the Phase I dose escalation stage of EPZ-5676 a DOT1L inhibitor. We achieved a $25 million proof-of-concept milestone in our – from our partner Celgene. As we saw objective responses in the target patient population a form of leukemia called mixed lineage leukemia in which there is a chromosomal rearrangement.

We also identified a potential expansion indication in 2013, a form of leukemia called MLL-PTD. In our EZH2 program compound EPZ-6438 we achieved a $6 million Phase I study initiation milestone from our partner Eisai and it also identified a new potential expansion indication in a solid tumors in which there is deficiencies of a protein called INI1. In our GSK collaboration we achieved a 4 million mile, $4 million development candidate milestone for one of our GSK targets.

5676 and 6438 have strong patent protection, composition of matter patents were granted last year for those two compounds as well as two other granted patents last year. And we continue our scientific leadership in this field of HMT or histone methyltransferases. During 2013, we had a successful IPO which raised $89 million and we finished our 2013 with cash and receivables or receivables of approximately $145 million, this puts us in a robust position through 2015. This is important to us because during the next few years we intend to move our two lead programs, DOT1L for acute leukemias, and EZH2 for non-Hodgkin lymphoma and solid tumors forward through clinical development, as well as continuing the preclinical development of our three targets that are partnered with GSK as well as novel histone methyltransferase targets in our platform.

Key events in 2014 include five clinical proof-of-concept programs as well as clinical data disclosure for major medical conferences. Three of those proof-of-concept programs will be in the DOT1L arena an adult study with mixed lineage leukemia, a pediatric study in which there is a similarly a genetic alteration driving that pediatric leukemia and an adult form of leukemia called MLL-PTD. EZH2 program we will have two plan proof-of-concept programs, a study in a genetically defined subset of non-Hodgkin lymphoma and synovial sarcoma in which there is a genetic drivers due to deficiency of a protein called INI1.

As I have mentioned these HMT target class that we are working in regulates gene expression by the addition of methyl groups and hence the name histone methyltransferases. This transfer of these methyl groups control gene expression and when misregulated, when the enzymes are misregulated, gene expression is misregulated and disease can result. Out of the 96 enzymes we’ve identified 20 that we prioritized based on their oncogenic mechanism and based on the demonstration that they appear to be drivers of a variety of hematologic and solid malignancies. This early focus on patients with genetically-defined cancers enables us to have a very focused clinical development strategy.

Two of our programs are currently in the dose escalation phase in which we determine safety, tolerability and pharmacokinetic parameters. The DOT1L program has moved to an expansion phase, which gives us an initial assessment of therapeutic effect, as we study only patients with the genetically-defined cancers as identified with companion diagnostic.

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