Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapeutics, today announced
that the Company has entered into a collaboration agreement with
Foundation Medicine, Inc. to support patient identification and
enrollment for Epizyme’s ongoing Phase 2 clinical trial of
tazemetostat in patients with non-Hodgkin lymphoma (NHL).
Foundation Medicine’s SmartTrials™ Precision Enrollment Program and
FoundationOne® Heme panel will assist in identifying a population
of individuals with NHL who harbor EZH2 mutations and constitute
specific cohorts in the Epizyme trial.
Tazemetostat is Epizyme’s oral, first-in-class EZH2
inhibitor being investigated in multiple ongoing clinical trials.
Early clinical data suggest tazemetostat has encouraging clinical
activity and a favorable safety profile in patients with relapsed
and refractory NHL.
“This agreement exemplifies our commitment to
execute enrollment in our ongoing Phase 2 NHL study, particularly
patients with EZH2 mutations,” said Robert Bazemore, president and
chief executive officer of Epizyme. “We are pleased to partner with
Foundation Medicine, an industry leader and innovator in molecular
information and comprehensive genomic profiling, to advance our
tazemetostat clinical program and accelerate identification of
patients who may benefit from this therapy.”
FoundationOne Heme is Foundation Medicine’s
validated, comprehensive genomic profiling assay, specifically
designed for hematological malignancies and sarcomas, which
identifies the unique genomic alterations in an individual’s cancer
and matches the findings with relevant targeted therapy and
clinical trial treatment options for patients. Through this
collaboration, Foundation Medicine’s SmartTrials Precision
Enrollment program will identify individuals across the U.S. living
with NHL who harbor EZH2 mutations as detected by FoundationOne
Heme in the course of routine clinical care. The treating
physicians of these identified patients will be contacted and
informed of Epizyme’s ongoing Phase 2 study of tazemetostat,
including relevant details about the trial, to assist the physician
in evaluating tazemetostat as a potential treatment option.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a first-in-class EZH2 inhibitor, is
currently being studied in ongoing Phase 2 programs in patients
with NHL. It is also being studied in adult and pediatric patients
with certain genetically defined solid tumors, including
INI1-negative and SMARCA4-negative tumors and synovial sarcoma, and
in patients with mesothelioma.
The company plans to initiate additional clinical
trials of tazemetostat in 2016, including a combination with R-CHOP
in collaboration with the Lymphoma Study Association and a
combination with Tecentriq™ (atezolizumab) in collaboration with
Genentech, a member of the Roche Group.
About SmartTrials Precision Enrollment
Program and FoundationOne®
HemeFoundation Medicine’s SmartTrials Precision
Enrollment program leverages the company’s unique combination of
broad collaborations with biopharma, industry-leading clinical
assays and the FoundationCORE™ genomic knowledgebase with more than
90,000 real-world genomic profiles to overcome the major roadblocks
to today’s clinical trial system, namely patient identification and
access to trials.
FoundationOne® Heme, an integrated DNA/RNA platform
using targeted hybrid-capture next-generation sequencing, is a
comprehensive genomic profile developed to detect genomic
alterations with therapeutic relevance, including single-nucleotide
substitutions, insertions and deletions, copy number alterations
and rearrangements, which are not fully evaluated using
conventional diagnostic assays. FoundationOne® Heme simultaneously
detects all classes of genomic alterations in the DNA of 405
cancer-related genes and employs RNA sequencing across 265 genes to
capture a broad range of gene fusions, a type of alteration that is
a common driver of hematologic cancers. It is designed to provide
physicians with clinically actionable information to guide
treatment options for patients based on the genomic profile of
their cancer.
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, 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 or the results of future trials, expectations
for regulatory approvals, whether the Company's collaborations will
be successful, including the collaboration with Foundation
Medicine, 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.
Foundation Medicine® and FoundationOne Heme® are
registered trademarks, and SmartTrials™ is a trademark, of
Foundation Medicine, Inc.
Tecentriq™ is a trademark of Genentech, Inc.,
(South San Francisco, CA, USA), a member of the Roche Group.
Epizyme Investors and Media Contact:
Julie DiCarlo, Epizyme, Inc.
jdicarlo@epizyme.com
(617) 401-0721
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