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. 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 trial represents a significant step for TransCode, as it targets patients with minimal residual disease—a condition where cancer cells persist at levels undetectable by standard imaging but detectable via liquid biopsy. These patients are at high risk for recurrence, and current standard of care offers no treatment options. TTX-MC138 is designed to inhibit metastasis by targeting microRNA-10b, a biomarker overexpressed in metastatic tumors. By intervening at the minimal residual disease stage, the therapy aims to prevent overt metastasis.
According to the press release, the Phase 2a trial will enroll up to 45 patients across multiple sites. The primary endpoint is the rate of circulating tumor DNA clearance, with secondary endpoints including recurrence-free survival and safety. The collaboration with Quantum Leap Healthcare enables efficient trial execution through the PRE-I-SPY platform, which uses adaptive trial design and shared infrastructure to accelerate drug development. This partnership may reduce costs and timelines compared to traditional trials.
The implications of this trial are far-reaching. If successful, TTX-MC138 could become a first-in-class treatment for minimal residual disease in colorectal cancer, addressing an unmet medical need. It may also validate the therapeutic approach of targeting microRNA-10b, paving the way for applications in other metastatic cancers. For TransCode, positive results could bolster its pipeline and attract further investment. The company is a clinical stage firm focused on RNA therapeutics for high-risk cancers, with a portfolio including other candidates designed to mobilize the immune system against cancer cells.
Investors and stakeholders can find the latest news and updates relating to RNAZ in the company’s newsroom at https://ibn.fm/RNAZ. For more details on the press release, visit https://ibn.fm/wuRri.
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