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September 02, 2015 4:07 AM ET

Biotechnology

Company Overview of Epizyme, Inc.

Company Overview

Epizyme, Inc., a clinical stage biopharmaceutical company, discovers and develops epigenetic therapies for cancer patients. Its proprietary product platform creates small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases (HMTs). The company has two HMTs inhibitors in clinical development for the treatment of patients with cancers. It is conducting a Phase II clinical trial of tazemetostat (EPZ-6438), an inhibitor that targets the EZH2 HMT for the treatment of non-Hodgkin lymphoma and INI1-deficient solid tumors; and two Phase I clinical trials of pinometostat (EPZ-5676), an inhibitor targeting the DOT1L HMT for the treatment of acute leukemia with geneti...

400 Technology Square

4th Floor

Cambridge, MA 02139

United States

Founded in 2007

86 Employees

Phone:

617-229-5872

Fax:

617-349-0707

Key Executives for Epizyme, Inc.

Chief Executive Officer, President, Secretary and Director
Age: 60
Total Annual Compensation: $652.8K
Chief Scientific Officer and President of Research
Age: 58
Total Annual Compensation: $531.7K
Chief Development Officer
Age: 53
Total Annual Compensation: $163.7K
Compensation as of Fiscal Year 2014.

Epizyme, Inc. Key Developments

Epizyme, Inc. Announces Acceptance of Investigational New Drug Application for Tazemetostat in Patients with INI1-Negative Tumors or Synovial Sarcoma

Epizyme, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for tazemetostat for the treatment of adults and pediatric patients with INI1-negative tumors or synovial sarcoma. In the second half of 2015, Epizyme plans to initiate a multi-center phase 2 study in adults and a multi-center phase 1 study in children to evaluate tazemetostat in patients with relapsed or refractory INI1-negative tumors or synovial sarcoma. INI1 is a critical component of the SWI/SNF regulatory complex, a chromatin remodeler that acts in opposition to EZH2. INI1-negative tumors have altered SWI/SNF function, resulting in aberrant and oncogenic EZH2 activity. This activity can be targeted by small molecule inhibitors of EZH2 such as tazemetostat. INI1-negative tumors are generally aggressive and are poorly served by current treatments. For example, current treatment of MRT, a well-studied INI1-negative tumor, consists of surgery, chemotherapy and radiation therapy, which are associated with limited efficacy and significant treatment-related morbidity. The annual incidence of patients with INI1 'negative tumors and synovial sarcoma in major markets, including the U.S., E.U. and Japan, is approximately 2,400.1 The adult phase 2 multicenter study will enroll up to 90 patients in three cohorts. The first cohort will be comprised of patients with malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK) and atypicalteratoid /rhabdoid tumor (ATRT). The second cohort will be comprised of patients with other INI1-negative tumors including epithelial sarcoma, epithelioid malignant peripheral nerve sheath tumor, extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma, and renal medullary carcinoma. The third cohort will be comprised of patients with synovial sarcoma. Dosing in all three cohorts will be at the recommended phase 2 dose of 800 mg twice per day (BID) with a tablet formulation, which Epizyme is also using in its ongoing phase 2 trial in non-Hodgkin lymphoma. The primary endpoint is overall response rate (ORR) for patients with INI1-negative tumors and progression-free survival (PFS) for patients with synovial sarcoma. Secondary endpoints include duration of response, overall survival (OS), PFS for patients with INI1-negative tumors, safety and pharmacokinetics (PK). The pediatric phase 1 multicenter study will enroll approximately 40 patients in a dose escalation design, followed by dose expansion, with an oral suspension of tazemetostat. The study will enroll subjects with INI1-negative tumors or synovial sarcoma. INI1-negative tumors include MRT, ATRT, RTK, and other INI1-negative tumors as previously described. The primary endpoint of study is safety with the objective of establishing the recommended phase 2 dose in pediatric patients. Secondary endpoints include PK, ORR, duration of response, PFS and OS. Epizyme will present a clinical update for the phase 1 portion of the ongoing phase 1/2 trial of tazemetostat at ESMO’s European Cancer Conference on September 26, 2015. This update will include safety data from the entire cohort and efficacy data from patients with solid tumors including INI1-negative tumors. EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include non-Hodgkin lymphomas, INI1-negative cancers such as malignant rhabdoid tumors, epithelioid sarcomas, and a range of other solid tumors including synovial sarcoma. In addition to the aforementioned studies in patients with INI1-negative tumors and synovial sarcoma, Epizyme is evaluating tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and solid tumors in a phase 1/2 study. The dose escalation and dose expansion cohorts from the ongoing phase 1 part of the study are fully enrolled. The phase 2 NHL study is the phase 2 portion of the phase 1/2 study. This trial is a five-arm, multi-center, international study that will assess the safety and activity of tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma. The study will enroll up to 30 patients in each arm, prospectively stratified for EZH2 mutation status and cell-of-origin, assuming each arm of the study achieves its primary response rate goal in its first stage. The company also plans to initiate additional clinical evaluations of tazemetostat, including a combination with R-CHOP in patients with DLBCL, and a combination with a B-cell signaling agent or other emerging targeted therapies for B-cell lymphomas.

Epizyme, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

Epizyme, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported collaboration revenue of $736,000 against $9,494,000 a year ago. Loss from operations was $25,785,000 against $13,311,000 a year ago. Net loss was $25,759,000 compared to $13,386,000 for the same period a year ago. Loss allocable to common stockholders was $0.63 per basic and diluted share against $0.40 per basic and diluted share a year ago. Loss before income taxes was $25,759,000 compared to $13,273,000 for the same period a year ago. For the six months, the company reported collaboration revenue of $1,647,000 against $22,885,000 a year ago. Loss from operations was $87,162,000 against $20,223,000 a year ago. Net loss was $87,085,000 compared to $20,270,000 for the same period a year ago. Loss allocable to common stockholders $2.29 per basic and diluted share against $0.63 per basic and diluted share a year ago. Loss before income taxes was $87,085,000 compared to $20,157,000 for the same period a year ago.

Epizyme, Inc. Announces Management Changes, Effective from September 10, 2015

Epizyme, Inc. announced that Robert Bazemore will succeed Robert Gould, Ph.D. as President and Chief Executive Officer of the company, effective from September 10, 2015. Robert Bazemore will also join the Epizyme board of directors. Dr. Gould has served on the Epizyme board of directors since 2008 and as CEO for the past five-and-a-half years. Following the transition, he will continue to serve on the board and will serve as a consultant to the company. Prior to joining Epizyme, Rob Bazemore served as Chief Operations Officer of Synageva. At Synageva, Rob was responsible for establishing the company's global commercial and medical organization to support the first product launch, as well as for leading the broader transition to a sustainable commercial enterprise.

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