Epizyme Gains on Positive Phase I Data on EPZ-6438
Epizyme, Inc.’s (EPZM) shares were up 4.6% following the company’s announcement of positive phase I study data on its oncology candidate, EPZ-6438. The open label, multi-center, phase I dose escalation study is evaluating EPZ-6438 (administered twice-daily orally) as a single agent for the treatment of advanced solid tumors and B-cell non-Hodgkin lymphomas (:NHL).
On the basis of the data as of Oct 20, 2014, Epizyme stated that EPZ-6438 had showed positive evidence of anti-tumor activity in both indications. Moreover, the company said that there remains potential for improved response to continued treatment. Five doses were evaluated in this study – 100 mg, 200 mg, 400 mg, 800 mg and 1600 mg. EPZ-6438 was well-tolerated.
In the study, EPZ-6438 showed either a partial or better response in four out of ten patients suffering from NHL. Three out of five patients with diffuse large B-cell lymphoma showed partial response, and one of them eventually achieved complete response upon continued treatment. One patient suffering from follicular lymphoma achieved partial response while three others with the same indication achieved stable disease. Additionally, a patient suffering from INI1-deficient malignant rhabdoid tumor achieved partial response under treatment with EPZ-6438.
Detailed data from the phase I study are expected in Dec 2014.
Meanwhile, Epizyme intends to conduct its first phase II study on EPZ-6438 in NHL patients with and without EZH2 mutation including diffuse large B-cell lymphoma and follicular lymphoma. Currently, the Data Monitoring Committee is reviewing the 800 mg oral dose of EPZ-6438 as the phase II study dose.
We remind investors that Epizyme has a collaboration and license agreement with Eisai Co., Ltd. (ESALY) for the development of small molecule HMT inhibitors including EPZ-6438. Under this agreement, Epizyme retains an opt-in right to co-develop and co-commercialize the products licensed to Eisai in the U.S. and share profits from sale of these products.
Epizyme currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Cytokinetics, Inc. (CYTK) and Biogen Idec Inc. (BIIB). Both carry a Zacks Rank #1 (Strong Buy).
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