Omega Therapeutics, Inc. announced a clinical supply agreement with Roche to evaluate OTX-2002, its lead candidate in development for the treatment of MYC-driven hepatocellular carcinoma (HCC), in combination with Roche's anti-PD-L1 therapy, atezolizumab, as part of Omega's Phase 1/2 MYCHELANGELO™ I clinical trial. The ongoing Phase 1/2 MYCHELANGELO I trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy (Part 1) and in combination with standard of care therapies (Part 2), in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study are anticipated in 2023.

Under the terms of this agreement, Roche will supply atezolizumab and Omega will evaluate the combination as part of the overall conduct of the trial. OTX-2002 is a first-in-class Omega Epigenomic Controller™ in development for the treatment of hepatocellular carcinoma (HCC). OTX-2002 is a programmable epigenetic mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

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. OTX-2002 is currently being evaluated in the Phase 1/2 MYCHELANGELO™ I trial in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene.