TTX-MC138's Phase 2a ctDNA clearance readout in colorectal MRD will determine whether a miRNA-10b inhibitor can become a registrational asset

TransCode Therapeutics is a clinical-stage company developing a targeted cancer drug for colorectal cancer patients with residual disease after surgery, which is not yet approved.

TTX-MC138 is a lipid nanoparticle-delivered anti-miR-10b oligonucleotide targeting Stage I–III colorectal cancer patients with detectable ctDNA after curative-intent therapy, a high-recurrence MRD population with no approved standard of care. The thesis turns on whether the Phase 2a single-arm trial demonstrates statistically meaningful ctDNA clearance sufficient to support an FDA-agreed registration design. The primary competitive and regulatory risk is that ctDNA clearance as a surrogate endpoint lacks regulatory precedent as a registration-enabling primary endpoint, and approved adjuvant checkpoint inhibitors like pembrolizumab are actively expanding into earlier-stage colorectal settings.