Omega Therapeutics' Cancer Program Shows Encouraging Anti Tumor Activity In Liver Cancer

Omega Therapeutics Inc OMGA announced preliminary data from the initial two dose level cohorts (n=8) from Part 1 of its Phase 1/2 MYCHELANGELO I study of OTX-2002 in hepatocellular carcinoma and other solid tumors associated with the c-MYC (MYC) gene. 

OTX-2002, the company's lead development candidate, is designed to pre-transcriptionally downregulate MYC, a master oncogene implicated in more than 50% of all cancers and approximately 70% of HCC cases.

MYCHELANGELO I is an ongoing Phase 1/2 open-label trial evaluating OTX-2002 as a monotherapy (Part 1) and in combination with standard-of-care therapies (Part 2).

Highly specific on-target engagement and intended epigenetic changes at the target genomic loci were observed for all eight patients across both dose levels, as evidenced by a robust increase in cell-free DNA MYC methylation signal following administration with OTX-2002. 

The increased methylation signal persisted throughout the two-week dosing interval.

Epigenetic modulation of MYC translated to rapid, robust, and durable downregulation of MYC expression in all eight patients, with mean reductions across both dose levels of approximately 55% observed seven days following administration with OTX-2002.

The increased methylation and corresponding downregulation of MYC expression observed clinically are within the ranges that led to anti-tumor activity in preclinical xenograft models.

Consistent pharmacokinetic (PK) data across both dose levels with rapid clearance and minimal variability observed within and between patients.

No accumulation was observed following repeat administration and low, transient levels of immune response were observed with no related adverse events or impact on PK.

OTX-2002 was generally well tolerated, with no dose-limiting toxicities.

Price Action: OMGA shares are down 14.70% at $2.56 on the last check Tuesday.