- Represents First Ever Epigenomic Controller, a New
Class of Programmable mRNA Therapeutics, to Receive IND
Clearance
- Phase 1/2 Clinical Trial Expected to Launch in 2H'22 and
Will Evaluate the Safety and Preliminary Antitumor Activity of
OTX-2002
CAMBRIDGE, Mass., July 14,
2022 /PRNewswire/ -- Omega Therapeutics, Inc.
(Nasdaq: OMGA) ("Omega"), today announced
that it has received clearance of its Investigational New Drug
(IND) application from the U.S. Food and Drug
Administration (FDA) to initiate a Phase 1/2, first-in-human,
clinical study of OTX-2002 for the treatment of
hepatocellular carcinoma (HCC). OTX-2002, an
Omega Epigenomic Controller (OEC), is
designed to downregulate c-Myc (MYC)
expression pre-transcriptionally through epigenetic modulation
while potentially overcoming MYC
autoregulation.
"We are thrilled to obtain clearance to advance OTX-2002 into
the clinic and are excited about the prospects of what this new
class of medicines may mean for patients in need," said
Mahesh Karande, President and Chief
Executive Officer of Omega Therapeutics. "This is an important
milestone for our company, representing our first program to
receive FDA clearance to enter the clinic and the first ever
clinical trial to evaluate an epigenomic controller. This new class
of programmable mRNA therapeutics leverages our groundbreaking
science and has broad potential applicability in many therapeutic
areas."
About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic Controller™ in
development for the treatment of HCC. OTX-2002 is an mRNA
therapeutic delivered via lipid nanoparticles (LNPs) and is
designed to downregulate MYC expression pre-transcriptionally
through epigenetic modulation while potentially overcoming MYC
autoregulation. The MYC oncogene is associated with aggressive
disease in up to ~70% of patients with HCC. An IND application for
OTX-2002 has been cleared by the FDA.
About Omega Therapeutics
Omega Therapeutics, founded by Flagship Pioneering, a
clinical-stage biotechnology company pioneering the first
systematic approach to use mRNA therapeutics as a new class of
programmable epigenetic medicines. The company's OMEGA Epigenomic
Programming™ platform harnesses the power of epigenetics, the
mechanism that controls gene expression and every aspect of an
organism's life from cell genesis, growth, and differentiation to
cell death. Using a suite of technologies, paired with Omega's
process of systematic, rational, and integrative drug design, the
OMEGA platform enables control of fundamental epigenetic processes
to correct the root cause of disease by returning aberrant gene
expression to a normal range without altering native nucleic acid
sequences. Omega's modular and programmable mRNA medicines, Omega
Epigenomic Controllers™, target specific epigenomic loci within
insulated genomic domains, EpiZips™, from amongst thousands of
unique, mapped, and validated genome-wide DNA-sequences, with high
specificity to durably tune single or multiple genes to treat and
cure diseases through Precision Genomic Control™. Omega is
currently advancing a broad pipeline of development candidates
spanning a range of disease areas, including oncology, regenerative
medicine, multigenic diseases including immunology, and select
monogenic diseases, including alopecia.
For more information, visit omegatherapeutics.com, or follow us
on Twitter and LinkedIn
Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding our product candidate pipeline, including efficacy, trial
design, regulatory submissions, approvals and timing thereof, the
launch of a clinical trial of OTX-2002 and timing thereof, and the
filing of future IND applications and timing thereof. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: the novel
technology on which our product candidates are based makes it
difficult to predict the time and cost of preclinical and clinical
development and subsequently obtaining regulatory approval, if at
all; the substantial development and regulatory risks associated
with epigenomic controller machines due to the novel and
unprecedented nature of this new category of medicines; our limited
operating history; the incurrence of significant losses and the
fact that we expect to continue to incur significant additional
losses for the foreseeable future; our need for substantial
additional financing; our investments in research and development
efforts that further enhance the OMEGA platform, and their impact
on our results; uncertainty regarding preclinical development,
especially for a new class of medicines such as epigenomic
controllers; the fact that our product candidates may be associated
with serious adverse events, undesirable side effects or have other
properties that could halt their regulatory development, prevent
their regulatory approval, limit their commercial potential, or
result in significant negative consequences; the impact of
increased demand for the manufacture of mRNA and LNP based vaccines
to treat COVID-19 on our development plans; difficulties
manufacturing the novel technology on which our OEC candidates are
based; our ability to adapt to rapid and significant technological
change; our reliance on third parties for the manufacture of
materials; our ability to successfully acquire and establish our
own manufacturing facilities and infrastructure; our reliance on a
limited number of suppliers for lipid excipients used in our
product candidates; our ability to advance our product candidates
to clinical development; and our ability to obtain, maintain,
enforce and adequately protect our intellectual property rights.
These and other important factors discussed under the caption "Risk
Factors" in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2022, and our other filings
with the SEC could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change.
Contacts
Investor contact:
Kevin
Murphy
Argot Partners
212.600.1902
ArgotOmega@argotpartners.com
Media contact:
Jason
Braco
LifeSci Communications
646.751.4361
jbraco@lifescicomms.com
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SOURCE Omega Therapeutics