TransCode Therapeutics, Inc. (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. The study is being conducted in collaboration with Quantum Leap Healthcare Collaborative through its PRE-I-SPY clinical trial platform and will assess the biological and clinical activity of TTX-MC138 in reducing recurrence risk in this high-risk patient population.
This trial is significant because it targets a critical unmet need: patients who have undergone curative-intent therapy but still harbor molecular evidence of disease are at high risk of relapse. By intervening early, TTX-MC138 may prevent or delay recurrence, potentially improving survival outcomes. The use of circulating tumor DNA as a biomarker allows for identification of patients with minimal residual disease who might otherwise be considered disease-free, offering a window for therapeutic intervention before overt metastasis.
TTX-MC138 is designed to target metastatic tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis. TransCode Therapeutics is a clinical-stage company pioneering immuno-oncology and RNA therapeutic treatments for high-risk and advanced cancers. In addition to TTX-MC138, the company has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells.
The collaboration with Quantum Leap Healthcare Collaborative leverages the PRE-I-SPY platform, which is known for its adaptive trial design and ability to efficiently evaluate multiple therapies. This partnership may accelerate the development of TTX-MC138 by providing access to a robust infrastructure and patient network.
For more information about the trial, visit the full press release at https://ibn.fm/wuRri. The latest news and updates relating to RNAZ are available in the company’s newsroom at https://ibn.fm/RNAZ.
