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.
Colorectal cancer is the third most common cancer worldwide, and minimal residual disease (MRD) is a significant predictor of recurrence. Patients who test positive for circulating tumor DNA (ctDNA) after curative treatment have a high likelihood of relapse, yet there are no approved therapies specifically targeting this state. TransCode's TTX-MC138 aims to address this unmet need by targeting microRNA-10b, a biomarker of metastasis that is overexpressed in many aggressive tumors, including those of colorectal origin.
The Phase 2a trial is designed to evaluate the safety, tolerability, and preliminary efficacy of TTX-MC138 in patients with ctDNA-positive MRD. The study will also explore biomarkers of response and resistance, which could inform future development. The collaboration with Quantum Leap Healthcare Collaborative provides access to the PRE-I-SPY platform, a novel adaptive trial design that allows for efficient evaluation of multiple investigational agents.
TransCode Therapeutics is a clinical stage company pioneering immuno-oncology and RNA therapeutic treatments for high risk and advanced cancers. Beyond 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 company's focus on RNA therapeutics represents a promising approach to targeting previously undruggable targets in oncology.
The initiation of this trial is a critical step for TransCode, as it moves forward in clinical development. If successful, TTX-MC138 could become the first approved therapy for MRD in colorectal cancer, potentially changing the standard of care. The use of the PRE-I-SPY platform may also accelerate the trial's timelines and provide robust data for regulatory discussions.
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.
