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Epizyme, Inc. (EPZM)
Morgan Stanley Global Healthcare Conference Call
September 11, 2013; 08:00 a.m. ET
Jason Rhodes - President & Chief Financial Officer
Sara Slifka - Morgan Stanley
[No presentation session for this event.]
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And I wanted to welcome you all this morning.
Okay let me go ahead and get started. So welcome to day three. I’m Sara Slifka, one of the biotech analysts at Morgan Stanley and I am up here with Jason Rhodes, President and CFO of Epizyme, welcome.
Just before we get started the disclosures, the statement holding disclosures, the Morgan Stanley disclosures are on the Morgan Stanley website.
So with that to start, since Epizyme is relatively new to the public world, can you just give us a brief overview of the company and its view and recent development.
Sure. Thanks Sara. Its great to be here and to have the opportunity to talk to everyone about Epizyme. Epizyme is a clinical stagy biopharmaceutical company. We are developing personalized therapeutic with patients with genetically defined cancers and we are specifically applying that strategy to a class of Epigenetic enzymes called Histone Methyltransferases.
The HMT are a very large product class. There are 96 members as we can define it and within that 96-member target class, we’ve actually prioritized 20 targets based on very clear oncogenic hypothesis. We then developed those drugs and its rapidity as possible in clinical development.
We actually focused clinical developments specifically on those patients with the genetically defined cancers and in order to do that, we developed companion diagnostics and we are doing that through partnerships with Abbott and Roche.
For example, our lead program is for genetically defined subtypes of acute leukemia called MLL-r or Mixed Lineage Leukemia. That product or compound is called 5676 and our second program that is also in the clinic currently and is called 6438, is targeting a genetically defined subtype of non-Hodgkin lymphoma that’s caused by point mutation in an HMT called EZH2.
Okay, great. So maybe to start, your interest in personalized medicine for oncology has really grown over the past two years. Can you talk about how your technology is different from others out there?
Sure. So obviously increasingly we are identifying and understating the specific rule, the genetic alternations play in driving very specific cancers and solutions. There’s some very good recent examples of that. Probably everyone here is familiar is zalco (ph) and the zalverath (ph) for example.
GSK just this year had a B-Raf inhibitor and also a MEK inhibitors and approved that had a similar kind of focus. So this idea of pointing targeted therapeutics to specific patients with genetically defined cancers is an approach that’s relatively new, but that’s becoming I think very well understood.
As I mentioned during the introduction, we are specifically applying that product strategy, which we think is very powerful, in a number of ways to this type of genetic target class.
And so our particular expertise at Epizyme is in the definition and understanding of this target class, the oncogenic role is genetically altered in HMT’s comply in cancer and we’ve done over the past 5.5 years, just build a propriety product platform that allows us to first understand the biology around these targets that interrogate and experiment, which is much easier said than done; to identifying novel chemistry and then ultimately as we have novelty programs, to move them into clinical development.
And so that overall product strategy I think is something that is increasingly understood in the oncology space and we are doing it in a very unique way and we certainly think when a leadership role is applying for this particular genetic target class.
Okay. So now we can move on to talk about 5676, the Phase I trial. Can you update us on where you are on enrolment and when we expect to see data in that trail?
Sure. So 5676 again is an inhibitor of an HMT called DOT1L. Due to a translocation, DOT1L becomes oncogenic and it drives the up regulation, the discretion of a set of leukemogenic gene and so it’s a very clear ontogenic driver for the subset of patients and they represent about 10% of all leukemia. So that initial population is about 5,000 patients for the year in terms of the annual incidence.
We entered a Phase I dose escalation stage in late 2012 and that study is ongoing. Really importantly that Phase I study has two stages. It has in dose escalation, which for practical purposes you can think of it being an all-comers within a few leukemia’s and so it doesn’t require the inclusion of the patients with the specific genetic alteration of these MLL-r patients, but in fact may and as of our IPO, which also is a May be disclosed as seeing one MLL-r patient and its actually selectively seen a biological response in that one patient, whereas we did not see a biological response in the non MLL patients in this study.
In terms of the specific status, we have six sites that are currently in the ruling. The dose escalation is continuing. We are on track to disclose top line results in the dose escalation study this year and also to initiate a second portion of that Phase I study, which we’re calling an expansion cohort. The expansion cohort will exclusively enroll MLL-r patients and so we expect to initiate that cohort also later this year.