Personalized Oncology IPO Epizyme

In earlier articles, we discussed several companies involved in personalizing oncology drugs including Foundation Medicine and Champions Oncology. With plans to personalize therapeutics for genetically defined cancers, one recent IPO, Epizyme, is at the forefront of this growing trend.

Business Focus

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Founded in 2007, Epizyme has taken advantage of sequencing of the human genome by developing a small molecular platform aimed at the inhibition of a particular class of enzymes that become oncogenic when genetic alterations occur. The inhibitors work on a 96-member class of enzymes known as histone methytransferases (HMT). Epizyme was founded with a focus on the histone methyltransferase (HMT) class of molecules, recognizing early on that they had oncogenic potential.

The company had a May 2013 IPO which priced at $15.00 per share. They are listed on the NASDQ as EPZM, and at the closing bell of the IPO they had a market price of $29.75. Today the stock has increased just over 20% from the opening price of the IPO.

Epizyme_Stock_Price

The company’s 796 million dollar market cap is due to investor interest in the potential of targeting alterations in DNA.

Management

Epizyme has a management team with extensive experience in pharmaceuticals, including CEO Robert Gould, who was Director of Novel Therapeutics at The Broad Institute of MIT and Harvard. Dr. Gould’s experience prior to that was as Vice President of Licensing and External Research at Merck Research Laboratories. President and Chief Financial Officer Jason P. Rhodes was formerly Vice President of Business Development at Alynylam Pharmaceuticals, Inc., a biopharmaceutical company. Prior to that, he was a founder and partner with Fidelity Investments’ biopharmaceutical venture capital group.

Funding

The company has collaborative partnerships for several of their programs in development, which have provided $120 million in non-equity funding through December of 2012. Therapeutic collaborations with Celegene, Eisai, GSK, Roche, and Abbott yield the potential of a billion dollars in research and development funding. Through March 31 of 2013, the company had $85 million in cash and cash equivalents.

Lead Product

Currently in Phase I clinical trials of a molecular inhibitor, EPZ-5676, which targets the treatment of mixed lineage leukemia, they expect to soon begin a Phase1 and 2 trial for a second molecular inhibitor sometime in 2013. Epizyme received orphan drug designation on August 16, 2013, for EPZ-5676. This allows the corporation special incentives which include tax credits, R & D funding, and reduced filing fees during development or at the time of application for market approval. The drug may qualify for seven years of marketing exclusivity independent of any other intellectual property. Epizyme retains all U.S. rights to EPZ-5676, and Celgene has an exclusive license for the product outside of the United States. Epizyme_Pipeline

Epizyme is in partnership with Abbot to develop a companion diagnostic to identify patients with mixed lineage leukemia-r, an aggressive subtype of two of the most common forms of acute leukemia. This tool will identify the patients who will benefit from early targeted intervention. Currently, the five-year overall survival rates for adult patients with the MLL-r subtype of AML ranges from 5 to 24%.

Investor interest in this company with products so early in development is not surprising given the strong management team with extensive experience both in research and new drug development, which is attractively coupled with the clear interest of several pharmaceutical giants who have committed to fund development in partnership with Epizyme. Epizyme is potentially four or five years away from releasing a viable product.

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