Epizyme Earns $6 Million Milestone Payment from GlaxoSmithKline for Initiation of Clinical Development with First-in-Class PR...
September 15 2016 - 6:30AM
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapeutics, today announced it
has earned a $6 million milestone payment from GlaxoSmithKline
(GSK). The milestone payment follows GSK’s initiation of patient
dosing in a Phase 1 clinical trial of GSK3326595 (formerly
EPZ015938), a first-in-class protein arginine methyltransferase-5
(PRMT5) inhibitor discovered by Epizyme and licensed to GSK. PRMT5
is a protein methyltransferase that is associated with a number of
human cancers.
“Epizyme has pioneered the discovery and
development of epigenetic therapies for the treatment of cancer,
with three agents discovered by Epizyme now in clinical
development,” said Robert Bazemore, President and Chief Executive
Officer, Epizyme. “Our collaboration with GSK represents an
important part of our strategy of partnering with industry leaders
to extend the breadth of our epigenetic therapies while providing
resources to help us accelerate our portfolio of assets. We look
forward to GSK’s continued progress with this program.”
GSK has initiated a Phase 1, dose-escalation study
to investigate the safety, pharmacokinetics, pharmacodynamics and
clinical activity of GSK3326595 in patients with solid tumors and
non-Hodgkin lymphoma.
“The introduction of this PRMT5 inhibitor into the
clinic by GSK is an exciting scientific achievement for Epizyme,”
said Robert A. Copeland, Ph.D., President of Research and Chief
Scientific Officer, Epizyme. “This milestone reinforces the
strength of our scientific capabilities, which have enabled us to
expand our platform into new epigenetic target classes of
potentially high importance in oncology. Through our collaborations
with GSK and other biopharmaceutical companies, as well as our
in-house research efforts, we have developed a number of novel
epigenetic programs that we believe hold tremendous potential,
including this first-in-class PRMT5 inhibitor.”
About the Epizyme-GSK
CollaborationUnder the terms of its collaboration and
license agreement with GSK, Epizyme granted GSK exclusive worldwide
license rights to methyltransferase inhibitors directed to three
targets. During the research term of the collaboration, Epizyme was
primarily responsible for pre-clinical research, and now GSK is
responsible for subsequent research, development and
commercialization of the three programs. Using its proprietary drug
discovery platform, Epizyme discovered and optimized compounds
targeting three methyltransferases, including PRMT5. GSK3326595 is
the first of these to enter the clinic. GSK holds worldwide rights
to all three programs. Epizyme has earned $59 million in up-front,
research, and milestone payments to date, and may receive up to an
additional $617 million from GSK if all milestones are met for all
three programs. Epizyme is eligible to receive up to double-digit
royalties on worldwide net sales of collaboration products.
About PRMT5 and GSK3326595PRMT5 is
a protein arginine methyltransferase (PRMT) that is reported to
have a role in diverse cellular processes, including tumorigenesis.
PRMT5 overexpression is observed in cell lines and primary patient
samples derived from a number of cancers, including lymphomas, lung
cancer, breast cancer and colorectal cancer. GSK3326595 (formerly
EPZ015938), a highly selective and orally bioavailable small
molecule, is the first PRMT5 inhibitor and the third epigenetic
investigational therapy derived from Epizyme’s proprietary
discovery platform to enter the clinic.
About Epizyme, Inc.Epizyme, Inc.
is a clinical-stage biopharmaceutical company creating novel
epigenetic therapeutics for people with cancer. Epizyme has built a
proprietary product platform to create small molecule inhibitors of
chromatin modifying proteins (CMPs), such as histone
methyltransferases (HMTs). CMPs are part of the system of gene
regulation, referred to as epigenetics, that controls gene
expression. Genetic alterations can result in changes to the
activity of CMPs, making them oncogenic (cancer-causing). By
focusing on the genetic drivers of cancers, Epizyme's targeted
science seeks to match the right medicines with the right patients.
For more information, visit www.epizyme.com.
Cautionary Note on Forward-Looking
StatementsAny 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," "plans," "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: uncertainties
inherent in the initiation of future clinical studies, whether the
Company’s collaborations such as its collaboration with
GlaxoSmithKline will be successful, availability of funding
sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements, other
matters that could affect the availability or commercial potential
of the Company’s therapeutic candidates or companion diagnostics
and other factors discussed in the "Risk Factors" section of our
Form 10-Q most recently filed with the SEC, and in our 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. 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. These
forward-looking statements should not be relied upon as
representing the Company's views as of any date subsequent to the
date hereof.
Investors and Media Contact:
Julie DiCarlo
Epizyme, Inc.
jdicarlo@epizyme.com
(617) 401-0721
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