Epizyme - What's Next?

(RTTNews) - Shares of Epizyme Inc. (EPZM) have lost 50% of their value over the last 7 months compared to the 1.2 % gain of the iShares Nasdaq Biotechnology ETF (IBB) index during the same period.

Epizyme is a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer and other serious diseases. Epigenetic therapy is a novel therapeutic approach that focuses on changes in DNA expression without altering the makeup of the genes themselves.

The Company's lead drug candidate is Tazemetostat, an internally developed first-in-class EZH2 inhibitor.

Tazemetostat as a monotherapy is under phase II studies in the indications of relapsed/refractory Diffuse Large B-Cell Lymphoma & Follicular Lymphoma; in adults with INI1-Negative Tumors like epithelioid sarcoma, synovial sarcoma, malignant rhabdoid tumor and renal medullary carcinoma, and in relapsed/refractory malignant mesothelioma patients with BRCA1-associated protein 1 (BAP1) loss-of-function. It is also being studied in a phase I dose escalation and dose expansion study in pediatric subjects with relapsed or refractory INI1-negative tumors.

As a combination therapy, Tazemetostat is being evaluated in a phase I trial in combination with Prednisolone in subjects with DLBCL, and a phase I trial in combination with Tecentriq in patients with relapsed or refractory DLBCL.

Also in the pipeline are Pinometostat, being developed in collaboration with Celgene, for the treatment of patients with MLL-r, a genetically defined acute leukemia, under phase I clinical trial in pediatric patients, and EZM8266, a G9a inhibitor, for the potential treatment of sickle cell disease, under preclinical testing.

A partial clinical hold on Tazemetostat clinical trials was slapped in April of this year, following a safety report of a pediatric patient who developed a secondary lymphoma in the phase I pediatric study of Tazemetostat.

Late last month, the FDA lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its Tazemetostat clinical trials.

However, the Tazemetostat clinical program continues to be on partial clinical hold in France and Germany, and Epizyme will be engaging with the respective regulators to resolve the issue.

Epizyme has a collaboration and license agreement with GlaxoSmithKline (GSK), under which Epizyme granted GSK exclusive worldwide license rights to methyltransferase inhibitors directed to three targets. GSK3326595 (formerly EPZ015938), developed under this collaboration is under a phase I trial in patients with solid tumors and non-Hodgkin lymphoma.

Near-term Catalysts:

-- Epizyme plans to present updated data from its phase II trial of Tazemetostat as a monotherapy in patients with epithelioid sarcoma at the European Society for Medical Oncology (ESMO) Congress that is scheduled to take place from October 19 to October 23, in Munich, Germany. -- If all goes well as planned, the NDA for Tazemetostat for the treatment of patients with epithelioid sarcoma is expected to be submitted in the first half of 2019.

Key Numbers:

Accumulated deficit: $526.3 million Cash on hand: $215.6 million at June 30, 2018; raised gross proceeds of $86.25 million in a public offering early this month. *Institutional Ownership: 77.30% *Total Shares Outstanding: 78 million

(*Data sourced from Nasdaq)

Shares of Epizyme have traded in a range of $8.61 to $21.40 over the last 1 year. The stock is currently up 3.17% at $9.77.