TransCode Advances TTX-MC138 into Phase 2a Trial for Colorectal Cancer
Event summary
- TransCode Therapeutics submitted an IND amendment for a Phase 2a trial of TTX-MC138 in colorectal cancer, expanding the PRE-I-SPY platform.
- The trial will enroll up to 45 patients with positive circulating tumor DNA (ctDNA) markers, targeting minimal residual disease (MRD).
- Dr. Paula Pohlmann of MD Anderson Cancer Center will lead the study, set to begin in early 2026.
The big picture
TransCode’s move into colorectal cancer with TTX-MC138 reflects a broader industry shift toward precision oncology, leveraging ctDNA as a prognostic tool. The collaboration with Quantum Leap underscores the growing role of adaptive trial platforms in accelerating drug development for high-risk cancers.
What we're watching
- Clinical Validation
- Whether TTX-MC138 demonstrates meaningful biological and clinical activity in the MRD setting.
- Regulatory Momentum
- The pace at which TransCode advances through Phase 2a, given the FDA's evolving stance on RNA therapeutics.
- Strategic Expansion
- How Quantum Leap’s PRE-I-SPY platform scales into new oncology indications beyond breast cancer.
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