Appointment of Jerald Korn as Chief Operating
Officer
First Patient Dosed in the Randomized Portion
of SYMPHONY-1 (EZH-302), Epizyme’s Phase 1b/3 Confirmatory Study of
Tazemetostat in Combination with R2
Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage
biopharmaceutical company developing and delivering transformative
therapies for cancer patients against novel epigenetic targets,
today announced a clinical update as well as the appointment of
Jerald Korn as Chief Operating Officer, reporting to President and
Chief Executive Officer, Grant Bogle.
“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) 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.
View the U.S. Full Prescribing Information here: Epizyme.com
About Epizyme, Inc.
Epizyme, Inc. is a fully integrated, commercial-stage
biopharmaceutical company committed to its mission of rewriting
treatment for cancer through novel epigenetic medicines. The
Company is focused on creating medicines that are targeted at
specific causes of diseases, that are orally administered,
tolerable, easy to take and based on a deep understanding of the
patients that may benefit from them. The Company aspires to change
the standard-of-care for patients and physicians by developing
medicines with fundamentally new mechanisms of action. For more
information, visit www.epizyme.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Epizyme, Inc. and other statements
containing the words “anticipate," “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: whether commercial sales of TAZVERIK for
epithelioid sarcoma and follicular lymphoma in the approved
indications will be successful or will increase to the levels
anticipated or at all; whether the prioritization of the company’s
development activities and cost reductions will achieve the
company’s objectives or forecasted cost savings; whether
tazemetostat will receive marketing approval for epithelioid
sarcoma or follicular lymphoma in other jurisdictions, full
approval in the United States or approval in any other indication;
uncertainties inherent in the initiation of future clinical studies
and in the availability and timing of data from ongoing clinical
studies; whether results from preclinical studies or earlier
clinical studies of the company’s product candidates will be
predictive of the results of future trials, such as the ongoing
confirmatory trials of TAZVERIK; whether results from clinical
studies will warrant meetings with regulatory authorities,
submissions for regulatory approval or review by governmental
authorities under the accelerated approval process; whether the
company will receive regulatory approvals, including accelerated
approval, to conduct trials or to market products; whether the
company’s collaborations and licensing agreements with third
parties will be successful; uncertainties as to the impact of the
COVID-19 pandemic on the company’s business, results of operations
and financial condition; whether the company's cash resources will
be sufficient to fund the company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements; other
matters that could affect the availability or commercial success of
tazemetostat; and other factors discussed in the “Risk Factors”
section of the company’s most recent Form 10-K or Form 10-Q filed
with the SEC and in the company's other filings from time to time
with the SEC. In addition, the forward-looking statements included
in this press release represent the company’s views as of the date
hereof and should not be relied upon as representing the company’s
views as of any date subsequent to the date hereof. The company
anticipates that subsequent events and developments will cause the
company’s views to change. However, while the company may elect to
update these forward-looking statements at some point in the
future, the company specifically disclaims any obligation to do
so.
TAZVERIK® is a registered trademark of Epizyme, Inc.
Revlimid + Rituximab (R2) is a registered trademark of Celgene
Corporation, a Bristol Myers Squibb company.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220315005094/en/
For More Information:
Media: Erin Graves media@epizyme.com (617) 500-0615
Investors: Caitlin Stern cstern@realchemistry.com
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