Omega Therapeutics Announces Submission of Investigational New Drug Application for OTX-2002, an Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma

Investigational New Drug Application Submitted by Omega Represents the First Epigenomic Controller in a New Class of Programmable mRNA Therapeutics

CAMBRIDGE, MA, USA I June 15, 2022 I Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega") today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC). OTX-2002, an Omega Epigenomic Controller, is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

"This is an important milestone for our Company, an IND achieved in approximately 26 months since we started working on the early constructs in discovery which culminated in OTX-2002. We are excited that this represents the first of many anticipated IND applications and the transition of the company to its next stage," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This also marks a milestone regulatory submission for the first epigenomic controller, a new class of programmable mRNA therapeutics enabled by our OMEGA platform. We believe our approach to engineering epigenomic controllers has immense potential across a broad range of diseases, including HCC, which carries a 5-year survival rate of only 10%. We look forward to advancing OTX-2002 into the clinic and bringing it one step closer to patients in need."

The Company plans to initiate a Phase 1 clinical trial in the U.S. to evaluate OTX-2002, following FDA clearance.

About OTX-2002

OTX-2002 is a first-in-class Omega Epigenomic Controller™ in development for the treatment of HCC. OTX-2002 is a mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate c-Myc (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 has been submitted to the FDA. 

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, is a development-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 deterministic 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. 

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SOURCE: Omega Therapeutics

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