On June 15, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega") reported 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) (Press release, Omega Therapeutics, JUN 15, 2022, View Source [SID1234616023]). OTX-2002, an Omega Epigenomic Controller, is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

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"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.