CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced it has earned an $8 million milestone payment from GlaxoSmithKline (GSK). The milestone payment follows GSK’s initiation of patient dosing in a Phase 1 clinical trial of GSK3368715, a first-in-class protein arginine methyltransferase1 (PRMT1) inhibitor discovered by Epizyme and licensed to GSK. PRMT1 has been implicated in a number of human cancers.
“We are very pleased to see the progress that GSK has made with its PRMT1 inhibitor program, which marks the second program under our collaboration agreement to enter the clinic,” said Robert Bazemore, president and chief executive officer of Epizyme. “This milestone reinforces the promising role that epigenetic medicines may play in treating a variety of diseases, and our leadership in the discovery of novel epigenetic targets. It also validates our strategic business model of establishing collaborations that allow us to focus our internal resources on our lead programs, while facilitating the advancement of novel treatments for people with cancer. We look forward to GSK’s continued progress with this clinical program.”
This Phase 1 study by GSK will assess the safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of GSK33368715 in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL) and selected solid tumors with frequent methyl-thioadenosine phosphorylase (MTAP)-deficiency.
About the Epizyme-GSK Collaboration
Under the terms of its
collaboration and license agreement with GSK, Epizyme granted GSK
exclusive worldwide license rights to methyltransferase inhibitors
directed to three targets. Using its proprietary drug discovery
platform, Epizyme discovered and optimized compounds targeting three
methyltransferases. During the research term of the collaboration, which
has been completed, Epizyme was primarily responsible for preclinical
research on such compounds. GSK is responsible for subsequent research,
development and commercialization of each program. Epizyme has earned an
aggregate of $89 million in up-front, research and milestone payments to
date, and may receive up to an additional $375 million from GSK if all
remaining milestones are met. Epizyme is eligible to receive up to
double-digit royalties on worldwide net sales of collaboration products.
About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage
biopharmaceutical company committed to rewriting treatment for cancer
and other serious diseases through novel epigenetic medicines. Epizyme
is broadly developing its lead product candidate, tazemetostat, a
first-in-class EZH2 inhibitor, with studies underway in both solid
tumors and hematological malignancies, as a monotherapy and combination
therapy in relapsed and front-line disease. The company also is
developing a novel G9a program with its next development candidate,
EZM8266, which is targeting sickle cell disease. By focusing on the
genetic drivers of disease, Epizyme's science seeks to match targeted
medicines with the patients who need them. 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: uncertainties relating to the Company’s
ability to resume enrollment in its tazemetostat trials and the timing
of such resumption, and the impact of the safety finding in the
company’s pediatric trial on enrollment of patients in ongoing and
future trials of tazemetostat following the lifting of the partial
clinical hold and the resumption of enrollment; uncertainties inherent
in the initiation of future clinical studies and in the availability and
timing of data from ongoing clinical studies; whether interim results
from a clinical trial will be predictive of the final results of the
trial; whether results from preclinical studies or earlier clinical
studies will be predictive of the results of future trials; 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
Fast Track Designation and Orphan Drug Designations will provide the
benefits for which tazemetostat is eligible; expectations for regulatory
approvals to conduct trials or to market products; 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 potential
of the company's therapeutic candidates; and other factors discussed in
the "Risk Factors" section of the company's most recent 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.