OTX-2101 is the Second Development Candidate
Arising from the Company's Pioneering OMEGA Epigenomic Programming™
Platform
CAMBRIDGE, Mass., Oct. 12,
2022 /PRNewswire/ -- Omega Therapeutics, Inc.
(Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company
pioneering the first systematic approach to use mRNA therapeutics
as a new class of programmable epigenetic medicines by leveraging
its OMEGA Epigenomic Programming™ platform, today announced that it
has selected OTX-2101 as the next Omega Epigenomic Controller™
(OEC) development candidate to advance into Investigational New
Drug (IND)-enabling studies for the treatment of non-small cell
lung cancer (NSCLC).
Omega scientists rationally engineered OTX-2101 to control the
expression of the c-Myc (MYC) oncogene, a historically undruggable
target in NSCLC. 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.
Genetic analysis has revealed that MYC overexpression is present in
approximately 60% of NSCLC1. Preclinical data presented
at the 2022 American Society of Gene & Cell Therapy (ASGCT)
Annual Meeting showed that OTX-2101 potently down-regulates MYC in
multiple NSCLC cell lines. OTX-2101 effectively reduced tumor
growth in vivo and was well tolerated in murine xenograft
models, further supporting its clinical potential. IND-enabling
activities for OTX-2101 are underway.
"NSCLC accounts for nearly 25% of cancer deaths worldwide and
despite its high prevalence, treatment options are limited. Our
approach to epigenomic programming has the potential to address
NSCLC by targeting a key oncogene implicated in a broad segment of
the patient population. In preclinical studies, OTX-2101 has
demonstrated clear anticancer activity supporting its clinical
potential and our overall approach to targeting MYC," said
Thomas McCauley, Ph.D., Chief
Scientific Officer of Omega Therapeutics. "We look forward to
advancing OTX-2101 through IND-enabling studies and to continuing
to leverage the power of our platform to realize the promise of
epigenetics to treat disease."
The OTX-2101 clinical development program will utilize a lung
tissue-targeting lipid nanoparticle (LNP) technology exclusively
licensed from Nitto Denko Corporation ("Nitto"). This represents
the first option exercised by the Company as part of an existing
arrangement that provides Omega the option to exclusively license
Nitto's LNP technology for therapeutic development across multiple
targets and tissue types.
"This milestone for OTX-2101, which comes on the heels of the
MYCHELANGELO™ I trial initiation for OTX-2002 for the treatment of
hepatocellular carcinoma, highlights the power of our OMEGA
Epigenomic Programming™ platform to engineer candidate mRNA
therapeutics customized to the biology of the disease," said
Mahesh Karande, President and Chief
Executive Officer of Omega Therapeutics. "Our data-driven platform
enables us to rapidly design novel medicines addressing the root
cause of disease and tailor our delivery strategy to target the
relevant cells and tissues. By leveraging both our internal
development efforts and strategic external partnerships, we are
able to accelerate clinical development of our OECs, with the goal
of bringing innovative new therapies to patients sooner. We are
excited to continue to deliver strong execution of our strategy,
meet committed milestones, and establish a deep pipeline of
promising candidates to treat a broad range of indications."
About OTX-2101
OTX-2101 is a first-in-class Omega Epigenomic Controller™ in
development for the treatment of non-small cell lung cancer
(NSCLC). OTX-2101 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. Genetic analysis
conducted by others has revealed that MYC overexpression is present
in approximately 60% of NSCLC1. Omega is currently
evaluating OTX-2101 in Investigational New Drug (IND)-enabling
studies.
About Omega
Therapeutics
Omega Therapeutics, founded by Flagship Pioneering, is 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-2101 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 June 30, 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.
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1Expression
and clinical significance of PD-L1 and c-Myc in non-small cell lung
cancer. J Cancer Res Clin Oncol, 2019 Nov; 145(11):
2663-2674. https://pubmed.ncbi.nlm.nih.gov/31541338/
|
Investor and Media Contact:
Eva Stroynowski
617.949.4370
estroynowski@omegatx.com
Media Contact:
Jason
Braco
LifeSci Communications
646.751.4361
jbraco@lifescicomms.com
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SOURCE Omega Therapeutics