On March 15, 2022 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, reported a clinical update as well as the appointment of Jerald Korn as Chief Operating Officer, reporting to President and Chief Executive Officer, Grant Bogle (Press release, Epizyme, MAR 15, 2022, View Source [SID1234610129]).
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"We are excited to welcome Jerald to Epizyme at a pivotal time for the organization," said Mr. Bogle. "Jerald’s breadth of experience leading a wide range of functions and working in biotech companies at our stage of development will be a welcomed addition to our senior executive team as we look to drive growth for TAZVERIK (tazemetostat) as a monotherapy, as well as advance the tazemetostat clinical development program across both hematologic and solid tumor malignancies."
"I am thrilled to be joining Epizyme at such an important time for the company," said Mr. Korn. "I have a passion for working in the oncology space and am excited by the opportunity to help execute on the continued launch of TAZVERIK and to fulfill Epizyme’s vision of developing transformative epigenetic medicines. I look forward to working alongside this incredible team as we focus on the strategic priorities where we believe we can make a meaningful impact for people living with cancer."
With more than 15 years in the biotech industry, Mr. Korn most recently served as the Chief Operating Officer and General Counsel at Kaleido Biosciences, where he oversaw legal, human resources, program management, quality, regulatory and other operations, as well as supporting the company with corporate strategy, including two financings, a pipeline prioritization and transition to a new laboratory and manufacturing facility. Prior to Kaleido, Mr. Korn held several leadership positions at TESARO, as well as senior positions at Cubist Pharmaceuticals, Millennium Pharmaceuticals (part of Takeda) and AMAG Pharmaceuticals. Mr. Korn began his career as an associate at the law firm Ropes & Gray and holds a bachelor’s degree with honors in economics from Harvard University and a J.D. with honors from Boston University School of Law.
SYMPHONY-1 Clinical Update
Epizyme also reported today that the first patient has been dosed in the Phase 3 portion of the SYMPHONY-1 (EZH-302) study, a confirmatory study assessing tazemetostat in combination with rituximab + lenalidomide (R2) compared with R2 plus placebo in patients with relapsed or refractory follicular lymphoma (R/R FL) previously treated with at least one systemic therapy, including those who are rituximab-refractory and/or have experienced progression of disease within two years.
"Dosing the first patient in the Phase 3 portion of the SYMPHONY-1 study is an important milestone for Epizyme and our clinical development of tazemetostat in R/R FL," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "As we enroll patients in the Phase 3 randomized portion of the study, we plan to continue to report longer term follow-up data from the Phase 1b safety run-in portion of the study as well as data from other combination studies of tazemetostat in both hematological and solid tumor malignancies that we are conducting."
Epizyme previously announced the completion of the 30-day waiting period for its protocol amendment submitted to the U.S. Food and Drug Administration in December 2021 with 800 mg twice-daily as the recommended Phase 3 dose. The Company is now engaged in global start-up activities, including sites in greater China with its collaboration partner HUTCHMED. The latest results of the Phase 1b safety run-in portion of the study were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021 and can be accessed here.
About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:
Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory studies.
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.