Epizyme Announces Tazemetostat to be Evaluated in NCI’s Recently Initiated NCI-COG Pediatric MATCH Trial
July 24 2017 - 4:05PM
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapies, today announced that
the National Cancer Institute (NCI), part of the National
Institutes of Health, has initiated its NCI-COG Pediatric MATCH
study, which includes a phase 2 evaluation of tazemetostat as one
of its treatment arms. Conducted under Epizyme’s Cooperative
Research and Development Agreement (CRADA) executed with NCI in
2016, this multi-institutional study will evaluate tazemetostat as
a monotherapy for pediatric patients with advanced solid tumors,
including CNS tumors, non-Hodgkin lymphoma or histiocytic disorders
that harbor gain of function mutations in EZH2, or loss of function
mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4. The
Pediatric MATCH study, which will be operationalized by the
Children’s Oncology Group (COG), aims to match targeted agents,
such as tazemetostat, with specific molecular changes identified
through genomic sequencing of refractory/recurrent tumors from
children and adolescents with cancer.
“We are very pleased to be participating in the Pediatric MATCH
trial as it will allow us to extend our exploration of
tazemetostat’s potential clinical utility in the treatment of
molecularly targeted tumors,” said Peter Ho, M.D., Ph.D., chief
medical officer of Epizyme. “We look forward to working with the
NCI and COG investigators to advance our understanding of
tazemetostat’s potential against these devastating cancers in
children and adolescents.”
“This trial would not have been possible without the
enthusiastic support of the partnering pharmaceutical companies, as
evidenced by their willingness to provide targeted agents for this
trial,” said NCI study co-chair Nita Seibel, M.D., of NCI’s
Division of Cancer Treatment and Diagnosis.
As part of the CRADA executed between Epizyme and NCI in 2016,
NCI has agreed to collaborate with Epizyme on clinical trials to
evaluate the safety and efficacy of tazemetostat in both adult and
pediatric patients with hematologic malignancies and solid tumors.
As part of the agreement, NCI will fund and sponsor all clinical
trials conducted under this collaboration.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a first-in-class EZH2 inhibitor, is
currently being studied in ongoing Phase 2 programs in both
follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms
of non-Hodgkin lymphoma; certain molecularly defined solid tumors,
including epithelioid sarcoma and other INI1-negative tumors; and
mesothelioma, as well as in combination studies in DLBCL.
Tazemetostat has been granted Fast Track designation by the U.S.
Food and Drug Administration for follicular lymphoma regardless of
EZH2 mutation and for DLBCL with EZH2-activating mutations, as well
as Orphan Drug designation for soft tissue sarcoma and malignant
rhabdoid tumors.
About the NCI-COG Pediatric MATCH
Trial1Pediatric MATCH is a precision medicine cancer
treatment clinical trial that analyzes patients’ tumors to
determine whether they contain genetic abnormalities for which a
targeted drug exists (that is, “actionable mutations”) and assigns
treatment based on the abnormality. This trial seeks to determine
whether treating cancers according to their molecular abnormalities
will show evidence of effectiveness.
About Epizyme, Inc. Epizyme, Inc. is a
clinical-stage biopharmaceutical company committed to rewriting
cancer treatment 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 and in relapsed and front-line disease. Using
the Company’s proprietary platform, Epizyme has pioneered the
identification and development of small molecule inhibitors of
chromatin modifying proteins (CMPs), such as tazemetostat. 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, which can allow cancer cells to
grow and proliferate. By focusing on the genetic drivers of
cancers, Epizyme's science seeks to match targeted medicines with
the specific patients that need it. For more information, visit
www.epizyme.com and connect with us on Twitter at
@EpizymeRx.
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 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 will be predictive of the
results of future studies; whether interim data from clinical
studies will be indicative of the final results of the study;
whether results from clinical studies will warrant meetings with
regulatory authorities or submissions for regulatory approval;
whether submissions for regulatory approval will be made when
anticipated or at all and whether these submissions will be
reviewed under the accelerated approval framework; whether the
Company will receive regulatory approvals to conduct trials or to
market products; whether the Company’s collaborations such as the
collaboration with NCI reported in this release will be successful;
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
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the SEC. In addition, the forward-looking statements included in
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hereof and should not be relied upon as representing the Company's
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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.
1 1. The National Cancer Institute:
http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/pediatric-match
Contacts:
Cheya Pope, Epizyme, Inc.
media@epizyme.com
617-229-7561
Monique Allaire, THRUST IR
monique@thrustir.com
(617) 895-9511
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