On April 8, 2022 Omega Therapeutics (NASDAQ: OMGA) (Omega), a development-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, reported that it will present preclinical data highlighting the potential of its lead Omega Epigenomic Controller, OTX-2002, to regulate overexpression of the c-Myc (MYC) oncogene in models of hepatocellular carcinoma (HCC) in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place in New Orleans, Louisiana, April 8-13, 2022 (Press release, Omega Therapeutics, APR 8, 2022, View Source [SID1234611786]).

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"Despite its essential role in a broad range of cancers, MYC has remained undruggable to date," said Thomas McCauley, Ph.D., Chief Scientific Officer of Omega Therapeutics. "However, we believe that targeting the MYC gene pre-transcriptionally within its Insulated Genomic Domain (IGD), and epigenetically tuning it using our epigenomic controller, could overcome the challenges that have limited previous technologies including small molecules, antisense oligos and siRNA. We believe that these data strongly support OTX-2002’s ability to tune and restore MYC expression to a normal range and demonstrate the broader potential of our Epigenomic Programming platform to tackle previously intractable diseases. We are excited to continue advancing OTX-2002 into clinical trials and look forward to filing an Investigational New Drug application in the first half of this year."

Key findings

A single dose of OTX-2002 induced durable changes in the epigenetic profile of the MYC gene
OTX-2002 reduced MYC mRNA expression and protein levels over approximately 2 weeks in vitro
Downregulation of MYC in multiple HCC cell lines resulted in significant loss in viability of MYC-addicted cancer cells while sparing normal cells
In murine xenograft HCC models, OTX-2002 significantly reduced tumor growth and was well-tolerated
Cumulatively, these data support the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for the clinical development of OTX-2002 in the first half of 2022.

The poster can be viewed on the Omega website at View Source

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 designed to modulate levels of c-MYC (MYC) expression by utilizing targeted mRNA-expressed proteins to mediate epigenetic regulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. Omega is currently evaluating OTX-2002 in Investigational New Drug (IND)-enabling studies.