Company Overview of Epizyme, Inc.
Epizyme, Inc., a clinical stage biopharmaceutical company, discovers and develops personalized therapeutics for patients with genetically defined cancers. It identifies the genetic alterations that create cancer causing genes, known as oncogenes; selects patients in whom the identified genetic alteration is found; and designs small molecule therapeutic product candidates to inhibit the oncogene. The company has two histone methyltransferases (HMT) inhibitors in clinical development for the treatment of patients with genetically defined cancers. It is conducting a Phase I clinical trial of its product candidate, EPZ-5676, an inhibitor targeting the DOT1L HMT for the treatment of acute leukemi...
400 Technology Square
Cambridge, MA 02139
Founded in 2007
Key Executives for Epizyme, Inc.
Chief Executive Officer
Total Annual Compensation: $564.7K
Chief Scientific Officer and Executive Vice President
Total Annual Compensation: $487.5K
Total Annual Compensation: $513.2K
Total Annual Compensation: $463.5K
Compensation as of Fiscal Year 2013.
Epizyme, Inc. Key Developments
Epizyme, Inc. Announces Results from the Phase 1 Dose Escalation Study of Investigational EZH2 Inhibitor EPZ-6438
Nov 19 14
Epizyme, Inc. announced results from the Phase 1 dose escalation study of the investigational EZH2 inhibitor EPZ-6438 (referred to as E7438 by Eisai) administered orally as a single agent in patients with advanced solid tumors and B-cell non-Hodgkin lymphomas. This open-label, multicenter, Phase 1 study investigated EPZ-6438 as a single agent in patients with advanced B-cell non-Hodgkin lymphomas (diffuse large B-cell lymphoma = 6, follicular lymphoma = 5, marginal zone lymphoma = 1) or advanced solid tumors (colorectal = 4, INI1-deficient malignant rhabdoid tumor = 1, INI1-deficient synovial sarcoma = 1, other solid tumors = 6). The study objectives included establishment of the maximum tolerated or recommended Phase 2 dose, safety, tolerability, pharmacokinetics and preliminary evaluation of anti-tumor activity. Patients on study were heavily pre-treated, with fourteen patients having received between two and four prior therapies and nine having received more than four prior therapies. Five dosing cohorts were studied: 100 mg (n=6), 200 mg (n=3), 400 mg (n=3), 800 mg (n=6) and 1600 mg (n=6). As of October 20, 2014, the following activity was observed in the 20 patients with advanced B-cell NHL or advanced solid tumors who were evaluable for efficacy; four of 10 evaluable NHL patients achieved a partial response (PR) or better, including one complete response (CR); among five evaluable DLBCL patients, three achieved a PR or better: one patient with a PR reported in August 2014 subsequently evolved to a CR upon continued treatment and remains on study at 41 weeks of treatment; one of the two patients who achieved a PR remains on study; among four evaluable patients with follicular lymphoma (FL), one achieved a partial response and remains on study; three achieved stable disease (SD) and of these, two remain on study; confirmatory sequencing in a central laboratory showed all 10 NHL patients evaluable for efficacy had wild-type EZH2, and responses were observed in both germinal center origin and non-germinal center origin disease; one patient with an INI1-deficient malignant rhabdoid tumor achieved a PR and remains on study; 10 patients with solid tumors were evaluable for efficacy, including two patients with INI1-deficient solid tumors; EPZ-6438 was well tolerated, and the majority of adverse events were Grade 1 or Grade 2; responses were seen across a range of doses to 800 mg BID.
Epizyme, Inc. Announces Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014
Nov 6 14
Epizyme, Inc. announced unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the third quarter, the company reported collaboration revenue of $8,177,000 against $8,444,000 a year ago. Loss from operations was $19,736,000 against $9,727,000 a year ago. Loss allocable to common stockholders was $19,700,000 or $0.58 per diluted share against $9,704,000 or $0.34 per diluted share a year ago.
For the nine months period, the company reported collaboration revenue of $31,062,000 against $32,165,000 a year ago. Loss from operations was $39,959,000 against $19,381,000 a year ago. Loss allocable to common stockholders was $39,970,000 or $1.23 per diluted share against $17,677,000 or $1.49 per diluted share a year ago.
Epizyme Reports Publication of Preliminary Findings from Phase 1 Study of DOT1L Inhibitor EPZ-5676
Nov 6 14
Epizyme, Inc. announced the publication of preliminary data from the Phase 1 trial of EPZ-5676, a potent and selective inhibitor of the DOT1L histone methyltransferase (HMT). EPZ-5676 is being developed for the treatment of acute leukemia with alterations in the MLL gene (MLL-r) or partial tandem duplications within MLL (MLL-PTD). The data in the abstract show that EPZ-5676 was safe and well tolerated in the 36 patients who were evaluable for safety across all dosing cohorts as of the abstract data cut-off on July 15. Adverse events were predominantly Grade 1 or Grade 2 in severity, and there were only two patients who discontinued treatment due to possibly drug-related adverse events. Of the 28 patients who were evaluable for efficacy, two MLL-r patients in the 54 mg/m(2) dosing cohort achieved complete responses, and biological activity was seen in several patients who experienced resolution of cutaneous leukemia or leukemia cell differentiation effects. The patients who achieved complete responses were the same two patients whose objective responses were reported by Epizyme in January 2014. The DOT1L Inhibitor EPZ-5676: Safety and Activity in Relapsed/Refractory Patients with MLL-Rearranged Leukemia (ASH Abstract #387). The Phase 1 clinical trial of EPZ-5676 is an open label, multi-center trial that has two stages. The first is a dose escalation stage in adult patients with advanced hematologic malignancies, including MLL-r patients. The second is an expansion stage that is only enrolling MLL-r and MLL-PTD patients. Study objectives included safety and tolerability, dose identification, pharmacokinetics, pharmacodynamics and early evidence of anti-leukemic activity. At the data cut-off for the ASH abstract submission, 36 patients had received at least one dose of EPZ-5676 via continuous intravenous infusion and were evaluable for safety. Thirty-one of these patients had acute myeloid leukemia (AML; 21 MLL-r, 5 MLL-PTD), four had acute lymphocytic leukemia (ALL; 3 MLL-r) and one had a myeloproliferative disorder (MPD; MLL-r). The median age at time of enrollment was 53 years (range: 20 to 81 years) and the median number of prior systemic therapies was two (range: 1 to 6 therapies). Fourteen patients had a prior allogeneic stem cell transplant. Adverse events reported in more than 15% of patients, independent of relationship to study drug, were largely Grade 1 or Grade 2 in severity and included anemia, fever/neutropenia, thrombocytopenia, constipation, diarrhea, nausea, chills, fatigue, mucosal inflammation, peripheral edema, hypomagnesemia, dyspnea and sepsis. Adverse events assessed by investigators to be drug related were leukocytosis, nausea and hypomagnesemia, and PR prolongation. The maximum tolerated dose has not been reached. Two patients discontinued treatment due to adverse reactions that were potentially study drug related. There were no deaths attributed to study drug treatment. Among 23 patients with MLL-r or MLL-PTD who had at least one post-baseline evaluation, one MLL-r patient achieved a morphologic complete response and one MLL-r patient achieved a cytogenetic complete response. Several patients experienced resolution of leukemia cutis or a treatment-related increase in neutrophils (PMN) and/or monocytes, consistent with a differentiation effect. The identification of the MLL-r by split signal FISH in mature PMN suggests a differentiation effect on the leukemic clone. Pharmacokinetic exposures were dose proportional, and steady state plasma concentrations were reached on the first day of dosing. The preliminary pharmacodynamic data show reduced histone H3K79 methylation from baseline in marrow and peripheral blood mononuclear cells after 15 days of treatment at doses above 36 mg/m(2) /day. H3K79 rebounded towards baseline levels by day 28 in patients who received treatment for 21 of 28 days, whereas among patients who received treatment for 28 of 28 days, methyl-mark inhibition was maintained throughout the cycle.
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