TransCode Therapeutics Initiates Phase 2a Trial of TTX-MC138 in Colorectal Cancer Patients with Minimal Residual Disease

TransCode Therapeutics (NASDAQ: RNAZ) has announced the initiation of a Phase 2a clinical trial evaluating its lead therapeutic candidate, TTX-MC138, in up to 45 colorectal cancer patients who remain circulating tumor DNA-positive following curative-intent therapy despite no radiographic evidence of disease, indicating minimal residual disease. Conducted in collaboration with Quantum Leap Healthcare Collaborative through its PRE-I-SPY clinical trial platform, the study will assess the biological and clinical activity of TTX-MC138 in reducing recurrence risk in this high-risk patient population.

This trial targets a critical unmet need: patients who test positive for circulating tumor DNA after initial treatment have a high likelihood of recurrence, yet no approved therapies exist to address this state. TTX-MC138 is designed to inhibit metastasis by targeting microRNA-10b, a biomarker strongly associated with metastatic progression. By focusing on patients with minimal residual disease, the trial aims to intervene early before overt metastasis occurs.

The collaboration with Quantum Leap Healthcare Collaborative, a nonprofit organization that runs the I-SPY platform, provides an efficient framework for testing novel therapies. The PRE-I-SPY platform uses adaptive trial designs and shared infrastructure to accelerate drug development, potentially reducing the time and cost of bringing new treatments to patients.

TransCode Therapeutics is a clinical stage company pioneering immuno-oncology and RNA therapeutic treatments for high risk and advanced cancers. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells.

The initiation of this Phase 2a trial represents a significant step forward in addressing the challenge of minimal residual disease in colorectal cancer, which accounts for a substantial portion of recurrences and deaths. If successful, TTX-MC138 could offer a new treatment paradigm for patients who currently have no options beyond monitoring for recurrence.

For more information about TransCode Therapeutics and its pipeline, visit the company's newsroom at https://ibn.fm/RNAZ. The full press release is available at https://ibn.fm/wuRri.