On December 11, 2025, TransCode Therapeutics, Inc. (RNAZ) announced the launch of a Phase 2a dose-expansion trial for its lead drug candidate. The 8-K filing disclosed a collaboration with Quantum Leap Healthcare Collaborative to study TTX-MC138 in colorectal cancer patients with minimal residual disease (MRD).

The Phase 2a trial follows successful Phase 1a results where TTX-MC138 achieved its primary safety endpoint and established a recommended Phase 2 dose. According to the filing, the Phase 1a trial enrolled patients with metastatic tumors overexpressing microRNA-10b, a biomarker targeted by the drug.

"The safety and durable clinical benefit observed in TransCode's Phase 1a trial with TTX-MC138 provide the basis for TransCode's decision to proceed with Phase 2a clinical testing." — Daniel Vlock, Consulting Clinician, TransCode Therapeutics

TransCode Therapeutics plans to begin the Phase 2a trial in the first half of 2026, according to the SEC filing. The trial will evaluate safety and biological activity as primary endpoints in colorectal cancer patients with MRD, a condition where cancer cells remain after treatment but are undetectable by standard imaging.

Laura Esserman, M.D., co-founder of Quantum Leap Healthcare Collaborative, commented on the trial's significance in addressing unmet medical needs. The filing includes her statement about the challenges of detecting and treating micrometastatic disease before it becomes visible.

"Detecting and treating micrometastatic disease before it becomes visible is one of the biggest unmet challenges in cancer." — Laura Esserman, M.D., co-founder of Quantum Leap Healthcare Collaborative

The 8-K filing includes nine risk factors related to drug development, clinical trial conduct, and financial conditions. These risks mention that TransCode Therapeutics may need additional funding and that trial results may not match preclinical expectations, according to the SEC document.