Omega Therapeutics to Present Trial-in-Progress Poster for Phase 1/2 MYCHELANGELO™ I Study at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium
January 17 2023 - 6:00AM
Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage
biotechnology company pioneering the development of a new class of
programmable epigenetic mRNA medicines, today announced that it
will present a trial-in-progress poster at the upcoming American
Society for Clinical Oncology 2023 Gastrointestinal Cancers
Symposium (ASCO-GI), taking place in San Francisco, Calif., and
virtually, January 19–21, 2023. The poster will highlight the
design of the ongoing MYCHELANGELO™ I study, a Phase 1/2 open-label
trial evaluating OTX-2002, a first-in-class Omega Epigenomic
Controller™ (OEC) candidate, for the treatment of hepatocellular
carcinoma (HCC) and other solid tumor types known for association
with the c-Myc (MYC) oncogene.
Details for the ASCO Gastrointestinal
Cancers Symposium Trial-in-Progress poster presentation are as
follows:
Title: A phase 1/2 open-label
study to evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics, and preliminary antitumor activity of OTX-2002 as
a single agent and in combination with standard of care in patients
with hepatocellular carcinoma and other solid tumor types known for
association with the MYC oncogene (MYCHELANGELO I).Abstract
#: TPS627Session Information:
Trials-in-Progress Poster Session B: Cancers of the Pancreas, Small
Bowel, and Hepatobiliary TractLocation: Level 1,
West Hall, Poster N16Date and Time: Friday,
January 20, 2023, from 12:00-1:30 p.m. PST and 4:30-5:30 p.m.
PST
The poster will be made available on the Omega
website at
https://omegatherapeutics.com/our-science/#publications-research at
the same time as the presentation.
About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic
Controller™ in development for the treatment of hepatocellular
carcinoma (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. MYC is a master
transcription factor that regulates cell proliferation,
differentiation and apoptosis and plays a significant role in more
than 50% of all human cancers. OTX-2002 is currently being
evaluated in the Phase 1/2 MYCHELANGELO™ I trial in patients
with relapsed or refractory HCC and other solid tumor types known
for association with the MYC oncogene;
visit clinicaltrials.gov (NCT05497453) for more
details.
About Omega Therapeutics
Omega Therapeutics, founded by Flagship
Pioneering, is a clinical-stage biotechnology company pioneering
the development of a new class of programmable epigenetic mRNA
medicines. The Company's OMEGA 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 unprecedented
precision epigenomic control. Omega’s pipeline of development
candidates span a range of disease areas, including oncology,
regenerative medicine, multigenic diseases including immunology,
and select monogenic diseases.
For more information, visit
omegatherapeutics.com, or follow us on Twitter and LinkedIn.
Forward-Looking StatementsThis
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 the
timing and design of our Phase 1/2 MYCHELANGELOTM I clinical
trial; the potential of the OMEGA platform to engineer programmable
epigenetic mRNA therapeutics that successfully regulate gene
expression by targeting insulated genomic domains; expectations
surrounding the potential of our product candidates, including
OTX-2002; and expectations regarding our pipeline, including trial
design, initiation of preclinical studies and advancement of
multiple preclinical development programs in oncology, immunology,
regenerative medicine, and select monogenic diseases. 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; potential delays in and unforeseen costs arising from
our clinical trials; 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 most recent Quarterly Report on Form
10-Q and our Annual Report on Form 10-K for the year
ended December 31, 2021, 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.
CONTACT
Investor contact:
Eva Stroynowski
Omega Therapeutics
617.949.4370
estroynowski@omegatx.com
Media contact:
Jason Braco
LifeSci Communications
646.751.4361
jbraco@lifescicomms.com
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