Epizyme Presents Preclinical Data on Novel G9a Program and Introduces Next Drug Development Candidate at the American Society...
December 11 2017 - 7:31AM
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company developing
novel epigenetic therapies, announced today new preclinical data
from its novel G9a program for sickle cell disease (SCD). The data
were reported during an oral presentation at the 59th Annual
Meeting & Exposition of the American Society of Hematology
(ASH) in Atlanta, Ga. In addition, the company announced that its
drug development candidate, EZM8266, a G9a inhibitor, will begin
IND-enabling studies in 2018.
It is widely understood within the SCD research community that
elevation of fetal hemoglobin, which is normally silenced after
birth, has disease-modifying potential for patients with
β-globinopathies, such as sickle cell disease and β-thalassemia. To
this end, multiple academic groups have previously discovered that
inhibition of the histone methyltransferase (HMT) G9a leads to
increased levels of fetal hemoglobin in preclinical in vitro
studies. Building upon these findings, scientists from Epizyme
leveraged their expertise in HMT drug discovery to generate potent,
selective inhibitors of G9a with drug-like properties. A tool
compound derived from these efforts induced on-target elevation of
fetal hemoglobin in cell culture assays. Additionally, this
compound elicited significant increases in mouse embryonic
hemoglobin, which is the rodent developmental equivalent of human
fetal hemoglobin. Epizyme believes these findings to be the first
in vivo study to demonstrate reactivation of developmental
hemoglobin with a G9a inhibitor.
“Sickle cell disease is considered one of the first genetically
defined diseases, yet despite all the advances of modern medicine,
it remains an area of significant medical need,” said Richard
Chesworth, DPhil, senior vice president of research at Epizyme.
“There is proof in nature that fetal hemoglobin can have true
disease-modifying potential. Our internally discovered small
molecule further illustrates this disease modifying potential and
differentiates Epizyme in the field of sickle cell disease.”
Based on its research efforts, Epizyme has named the next drug
development candidate in the company’s pipeline, EZM8266—a potent,
selective and orally bioavailable G9a inhibitor. Throughout 2018,
Epizyme will work to advance EZM8266 toward clinical initiation,
completing the necessary pre-IND work, including GLP toxicology
studies. Epizyme holds worldwide development and commercialization
rights to EZM8266.
"We are excited about the potential of our novel, internally
discovered program,” said Robert Bazemore, president and chief
executive officer of Epizyme. “This mechanism, combined with our
data, give us great confidence in targeting G9a. We look forward to
advancing EZM8266 toward clinical development and the continued
execution of our vision through 2020.”
The oral presentation provides details on Epizyme’s tool
compound that supports further study of G9a inhibition and the
reactivation of fetal hemoglobin (abstract #537): Reawakening of
Human Fetal Hemoglobin and an Epigenetic Path to the Clinic for
Sickle Cell Disease and Beta-Thalassemia: Identification of an
Orally-Available, Potent, and Selective Euchromatic Histone Lysine
Methyltransferase 1 and 2 (EHMT1/2) Inhibitor.
About Sickle Cell DiseaseSickle cell
disease (SCD) is an inherited red blood cell disorder. People
with SCD have abnormal hemoglobin, called hemoglobin S
or sickle hemoglobin, in their red blood cells. A monogenic
disease, SCD is most common in people with African ancestry.
Approximately 300,000 people have sickle cell disease globally,
with an estimated 150,000 of those patients located in the U.S. and
Europe. Potential complications include stroke, vaso-occlusive
crises (VOC) associated with pain attacks, acute chest syndrome and
anemia. Recurrent acute pain crises and chronic long-term organ
damage are the hallmarks for SCD. However, symptoms of SCD can vary
significantly in different patients, and better treatments for SCD
patients are needed. Life expectancy of SCD patients still
lags the life expectancy of the general population.
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 is also developing a novel G9a
program and its next development candidate, EZM8266, 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 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.
Contacts:Cheya Pope, Epizyme,
Inc.media@epizyme.com 617-229-7561
Monique Allaire, THRUST IRmonique@thrustir.com 617-895-9511
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