On May 27, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported the initiation of its Phase 2a clinical trial. The study is to evaluate TransCode’s lead therapeutic candidate, TTX‑MC138, in patients with circulating tumor DNA (ctDNA) positive colorectal cancer following curative‑intent therapy. The trial is being conducted in collaboration with Quantum Leap Healthcare Collaborative (QLHC), sponsor of the PRE‑I‑SPY clinical trial platform. The trial builds on growing clinical and scientific momentum supporting ctDNA‑guided strategies targeting minimal residual disease (MRD) in colorectal cancer.
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The Phase 2a clinical trial is expected to enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have no radiographic evidence of disease, but remain or become ctDNA-positive, indicating the presence of minimal residual disease.
Principal investigators are Dr. Emil Lou of the University of Minnesota and Dr. Zhaohui Jin of the Mayo Clinic Comprehensive Cancer Center. The trial is chaired by Dr. Paula Pohlmann of the MD Anderson Cancer Center.
The trial leverages clinical sites currently participating and actively recruiting in QLHC’s PRE‑I‑SPY platform trial. Several of those clinical sites are part of the National Comprehensive Cancer Network (NCCN). Those centers have considerable expertise and are at the forefront defining standard-of-care practices for the treatment of cancer.
It is anticipated that the trial will produce new data about the importance of ctDNA testing and the role of TTX-MC138 in reducing the risk of cancer recurrence in this at-risk patient population. The trial has been submitted to the U.S. Food and Drug Administration and received Institutional Review Board approval, enabling site activation and commencement of patient enrollment.
This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the minimal residual disease setting where therapeutic intervention may have the greatest opportunity to improve long-term outcomes. ctDNA testing is becoming increasingly important in oncology, particularly in colorectal cancer, because it provides a highly sensitive, real-time measure of residual disease and information about tumor biology that traditional methods often fail to detect. This approach has recently been successfully employed in the treatment of patients with muscle invasive bladder cancer.
"TTX-MC138’s safety profile, coupled with the durability of its anti-tumor effects, observed in TransCode’s Phase 1a clinical trial is particularly encouraging. These findings are consistent with the drug’s mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions TransCode and its collaborators to potentially intervene earlier in a patient’s disease, and may in the future offer a new therapeutic option for patients at risk of developing metastatic disease" noted Daniel Vlock, MD, TransCode’s Consulting Clinician.
About TTX-MC138
TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO (Free ESMO Whitepaper) 2025.
(Press release, TransCode Therapeutics, MAY 27, 2026, View Source [SID1234666118])