Omega Therapies reveal new candidate for development of an epigenomic controller targeting non-small cell lung cancer led by MYC

OTX-2101 is the second candidate to develop the leading OMEGA Epigenomic Programming™ platform

Cambridge, Massachusetts.And the October 12, 2022 /PRNewswire/ – Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), the clinical-stage biotechnology company pioneering the first systematic approach to using mRNA therapies as a new class of programmable epigenetic drug by leveraging OMEGA Epigenomic™ programming, today announced that it has selected OTX-2101 as the candidate Following the development of the Omega Epigenomic Controller™ (OEC) to advance in new drug-enabling (IND) studies for the treatment of non-small cell lung cancer (NSCLC).

Omega scientists rationally designed OTX-2101 to control the expression of the c-Myc oncogene (MYC), a historically indestructible target in NSCLC. MYC is a key transcription factor that regulates cell proliferation, differentiation and apoptosis and plays an important role in more than 50% of all human cancers. Genetic analysis showed that MYC overexpression is present in approximately 60% of NSCLC1. Preclinical data Foot At the 2022 American Society for Genetic and Cell Therapy (ASGCT) Annual Meeting, it was shown that OTX-2101 effectively regulates MYC in several NSCLC cell lines. OTX-2101 effectively reduced tumor growth in vivo It was well tolerated in xenograft models of mice, further supporting its clinical potential. IND enablement activities for OTX-2101 are ongoing.

“NSCLC accounts for approximately 25% of cancer deaths worldwide and despite its high prevalence, treatment options are limited. Our epigenomic programming approach has the potential to address NSCLC by targeting one of the major oncogenes implicated in a broad patient population.” Studies, OTX-2101 have demonstrated clear anticancer activity that supports its clinical potential and our general approach to targeting MYC,” Thomas McCauley, Ph.D., chief scientific officer of Omega Therapeutics. “We look forward to advancing OTX-2101 through IND-enabled studies and continuing to leverage the power of our platform to realize the promise of epigenetics to treat diseases.”

The OTX-2101 Clinical Development Program will use lung tissue-targeting lipid nanoparticle (LNP) technology licensed exclusively from Nitto Denko Corporation (“Nitto”). This is the company’s first option as part of an existing arrangement that provides Omega with the option to exclusively license Nitto LNP technology for therapeutic development across multiple tissue types and targets.

“This achievement for OTX-2101, which comes on the heels of the initiation of the MYCHELANGELO™ I trial of OTX-2002 for the treatment of hepatocellular carcinoma, highlights the power of the OMEGA Epigenomic Programming™ platform to design candidate mRNA therapies customized for the biology of the disease” Mahesh KarandiPresident and CEO of Omega Therapeutics. “Our data-driven platform enables us to rapidly design new drugs that address the root cause of disease and adapt our delivery strategy to target related cells and tissues. By leveraging internal development efforts and strategic external partnerships, we are able to accelerate the clinical development of our OECs, with the goal of delivering new and innovative therapies. to patients sooner. We are excited to continue to deliver robust implementation of our strategy, meet committed milestones, and create a deep line of promising candidates to treat a wide range of indications.”

About OTX-2101

OTX-2101 is a first-of-its-kind Omega Epigenomic Controller™ in development for the treatment of non-small cell lung cancer (NSCLC). OTX-2101 is an mRNA therapy delivered via lipid nanoparticles (LNPs) that is designed to pre-regulate MYC expression through genetic modification with the potential to overcome MYC self-regulation. Genetic analysis by others has shown that MYC overexpression is present in approximately 60% of NSCLC1. Omega is currently evaluating OTX-2101 in New Drug Enablement (IND) studies.

About Omega Therapies

Omega Therapeutics, founded by Flagship Pioneering, is a clinical-stage biotechnology company pioneering the first systematic approach to using mRNA therapies as a new class of programmable epigenetic drugs. 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 formation, growth and differentiation to cell death. Using a combination of technologies, combined with the Omega process for systematic, rational and integrative drug design, the Omega platform enables control of essential genetic processes to correct the root cause of disease by returning aberrant gene expression to the normal range without altering the original DNA sequences. Omega modular and programmable mRNA drugs, Omega Epigenomic™ controllers, targeting specific gene sites within isolated genomic domains, EpiZips™, among thousands of unique, specific, genome-wide-dependent DNA sequences, with high specificity to permanently tune single or multiple genes to treat Diseases and their treatment with Precision Genomic Control™ technology. Omega is currently developing a wide range of development candidates covering a range of disease areas, including oncology, regenerative medicine, polygenic diseases including immunology, and specific single-gene diseases, including alopecia.

For more information visit omegatherapeutics.comor follow us Twitter And the 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 in this press release that are not related to matters of historical facts should be considered forward-looking statements, including but not limited to statements regarding the line Our product filter tubes, including efficacy, trial design, regulatory submissions and approvals, and timing, launch and timing of a clinical trial for OTX-2101, and submission and timing of future IND requests. These statements are neither promises nor warranties, but involve known and unknown risks, uncertainties and other significant factors that may cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements. Data, including, but not limited to, the following: the new technology on which our product candidate is based makes it difficult to predict the time and cost of preclinical and clinical development and thus obtain regulatory approval, if any; The intrinsic developmental and regulatory risks associated with epigenomic control machinery due to the novel and unprecedented nature of this new class of drugs; Our limited operating history; significant losses incurred and the fact that we expect to incur significant additional losses for the foreseeable future; Our need for significant additional funding; our investments in research and development efforts that further enhance the Omega platform and its impact on our results; Uncertainty regarding preclinical development, especially for a new class of drugs such as epigenomic controllers; the fact that our candidate products may be associated with serious adverse events or unwanted side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or lead to significant negative consequences; Impact of the growing demand for manufacturing mRNA and LNP-based vaccines for the treatment of COVID-19 on our development plans; Difficulties in manufacturing the new technology on which our ECO candidates depend; our ability to adapt to rapid and significant technological changes; our reliance on third parties to manufacture the materials; Our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for the lipid excipients used in our filter products; Our ability to take our product candidates to clinical development; and our ability to appropriately acquire, maintain, enforce and protect our intellectual property rights. These and other significant 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 Securities and Exchange Commission, could cause actual results to differ materially from those indicated. to them by the forward-looking statements contained in this press release. Any forward-looking statements represent management’s estimates as of the date of this press release. While we may choose to update these forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause us to change our views.

Investor contact and media:
Eva Stronovsky

Media contact:
Jason Bracco
LifeSci . Communications

(PRNewsfoto/Omega Remedies)

(PRNewsfoto/Omega Remedies)



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