TransCode Therapeutics, Inc. (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. This trial is 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.
The announcement marks a significant step for TransCode as it advances its pipeline targeting metastatic tumors. TTX-MC138 is designed to treat tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis. By focusing on patients with minimal residual disease—those who have completed curative therapy but still show signs of cancer through circulating tumor DNA—the trial addresses a critical unmet need. These patients are at high risk of recurrence, and current standard of care often involves monitoring without active intervention until radiographic evidence of disease appears.
The Phase 2a trial's primary endpoints will evaluate biological activity and clinical efficacy, potentially providing a new therapeutic option for colorectal cancer patients. If successful, TTX-MC138 could change the treatment paradigm for minimal residual disease, offering a proactive approach to prevent recurrence. This is particularly important because colorectal cancer is one of the most common cancers worldwide, and recurrence after curative-intent therapy remains a major challenge.
TransCode Therapeutics is a clinical-stage company pioneering immuno-oncology and RNA therapeutic treatments for high-risk and advanced cancers. The company's lead candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b. 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.
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