TransCode Therapeutics filed an Investigational New Drug amendment with the U.S. Food and Drug Administration to launch a Phase 2a study of its lead RNA therapeutic, TTX‑MC138, in patients with colorectal cancer who have completed curative‑intent therapy and exhibit circulating tumor DNA, a marker of minimal residual disease.
The trial will enroll up to 45 patients and will be conducted through Quantum Leap Healthcare Collaborative’s PRE‑I‑SPY platform, marking the first expansion of that platform into colorectal cancer and the first dose‑expansion phase for TTX‑MC138. Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center will lead the study.
Senior Vice President of Operations Sue Duggan said the IND submission “marks a pivotal step in TransCode’s clinical development program, positioning TTX‑MC138 where its mechanism of action has the potential to deliver meaningful benefit to patients.” She added that the partnership with Quantum Leap’s PRE‑I‑SPY program “supports the expansion of this platform into new indications such as colorectal cancer.”
The regulatory milestone is significant because it moves TTX‑MC138 beyond pre‑clinical and early‑phase studies into a higher‑risk, post‑treatment population. Success in this setting could validate the platform’s reported 98 % RNA uptake in metastatic tumors and open the door to broader oncology applications, strengthening TransCode’s competitive position in the RNA therapeutics space.
TTX‑MC138 targets microRNA‑10b, a biomarker associated with metastasis, and the trial’s focus on minimal residual disease addresses a high‑risk population with limited treatment options. The PRE‑I‑SPY platform’s established infrastructure and Dr. Pohlmann’s expertise further enhance the study’s credibility and potential for meaningful clinical data.
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