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TransCode Therapeutics announced further results of the Phase 1a dose escalation clinical trial. The trial met its primary endpoint of safety, with positive tolerability, combined with disease stabilization in multiple patients, and the absence of dose-limiting toxicities with its lead therapeutic candidate TTX-MC138. TTX-MC138, an investigational inhibitor of the key metastatic driver, microRNA-10b, has shown durable disease control. These findings support advancing TTX-MC138 into Phase 2a clinical development to assess efficacy in patients with circulating tumor DNA, or ctDNA, positive colorectal cancer following curative-intent therapy. TTX-MC138 has been administered to 16 patients who received 86 doses. The median treatment duration was 11.3 weeks, with a range of four to 52.4 weeks, representing 2 to 20 cycles of treatment. Notably, three patients remain on trial, and continue to receive TTX-MC138. One patient is at 21 cycles of treatment, another is at 16 cycles, and the third one is at 14 cycles of treatment. TransCode believes these results support its selection of the recommended Phase 2a dose of 4.8mg/kg. In addition, the assessment of the trial patient population underscored the potential for durable disease control in participants with metastatic cancer. A clinical study report is in process. Several presentations are planned at future scientific congresses.

TransCode Therapeutics announced 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 positive colorectal cancer following curative-intent therapy. The trial is being conducted in collaboration with Quantum Leap Healthcare Collaborative, 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 in colorectal cancer. 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.

Transcode Therapeutics files to sell 15.96M shares of common stock for holders