TransCode Therapeutics (NASDAQ: RNAZ) 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, conducted in collaboration with Quantum Leap Healthcare Collaborative through its PRE-I-SPY clinical trial platform, will assess the biological and clinical activity of TTX-MC138 in reducing recurrence risk in this high-risk patient population.
This trial addresses a significant unmet need in colorectal cancer care. Patients with minimal residual disease, as detected by circulating tumor DNA, face a high risk of recurrence, yet no approved therapies specifically target this state. TTX-MC138 is designed to inhibit microRNA-10b, a biomarker associated with metastasis. By targeting this microRNA, the therapy aims to prevent or delay the emergence of overt metastatic disease.
The collaboration with Quantum Leap Healthcare Collaborative leverages the PRE-I-SPY platform, which is designed to efficiently evaluate multiple investigational agents in parallel, potentially accelerating the development of effective treatments. The Phase 2a trial will enroll participants across multiple sites and will monitor outcomes such as clearance of circulating tumor DNA and recurrence-free survival.
TransCode Therapeutics is a clinical-stage company focused on immuno-oncology and RNA therapeutics for high-risk and advanced cancers. Beyond TTX-MC138, the company has a portfolio of first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. The company’s newsroom provides updates on RNAZ at https://ibn.fm/RNAZ.
This announcement is important because it represents a potential step forward in treating minimal residual disease, a condition that often leads to recurrence and metastasis. If TTX-MC138 proves effective, it could offer a new option for colorectal cancer patients who currently lack targeted therapies after curative-intent treatment. The use of the PRE-I-SPY platform may also expedite the development process, bringing promising therapies to patients more quickly.
