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TransCode Therapeutics, in collaboration with Quantum Leap Healthcare Collaborative, announced the submission to the U.S. FDA of an Investigational New Drug application amendment for a planned Phase 2a clinical trial with TransCode's lead therapeutic candidate, TTX-MC138. The study will be conducted by Quantum Leap within their PRE-I-SPY program, a leading platform for innovative oncology clinical trials, and represents the program's first expansion into colorectal cancer.

TransCode Therapeutics announced the publication of preclinical research supporting the application of its lead candidate, TTX-MC138, for the treatment of glioblastoma multiforme. The article was published in the peer-reviewed Journal of Functional Biomaterials. The study, entitled "Nanotherapy Targeting miR-10b Improves Survival in Orthotopic Glioblastoma Models," resulted from a collaboration between TransCode and Michigan State University. The study was led by Dr. Anna Moore, Professor, Director of the Precision Health Program, and Associate Dean for Research Development at the College of Human Medicine at Michigan State University and scientific co-founder of TransCode. The study demonstrated delivery of TTX-MC138 to human GBM tumors implanted into the brains of murine models after intravenous injection, resulting in sustained target engagement within the tumor. TTX-MC138 also induced apoptotic activity in tumors by five-fold, consistent with observed induction of tumor cell death. Importantly, treatment with TTX-MC138 resulted in a statistically significant increase in survival.

Transcode Therapeutics files $150M mixed securities shelf

TransCode Therapeutics and Quantum Leap Healthcare Collaborative announce a new collaboration to evaluate TransCode's therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform. The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and are ctDNA positive. The Phase 2a portion of the trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center.