NEW YORK – Omega Therapeutics on Thursday said it signed a clinical supply agreement with Roche for a Phase I/II trial of its lead candidate, OTX-2002, with Roche's anti-PD-L1 therapy, atezolizumab, in MYC-driven hepatocellular carcinoma (HCC).
Under the terms of the agreement, Roche will supply atezolizumab while Omega conducts the ongoing trial. In the first part of the MYCHELANGELO Phase I/II trial, researchers will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OTX-2002 alone in patients with relapsed or refractory HCC or other tumor types commonly driven by MYC. The second part of the trial will evaluate the combination of OTX-2002 and atezolizumab. The Cambridge, Massachusetts-based Omega expects preliminary data from the Phase I portion monotherapy portion of the trial in 2023.
OTX-2002 is designed to downregulate MYC transcription, an approach Omega refers to as epigenomic control. According to the company, OTX-2002 has shown anti-tumor activity in preclinical studies that is synergistic with standard therapies for HCC, including anti-PD-1 and anti-PD-L1 therapies. The company's strategy is to simultaneously disrupt multiple mechanisms of cancer progression.