TransCode Therapeutics (NASDAQ: RNAZ) announced the submission of an Investigational New Drug (“IND”) application amendment to the U.S. Food and Drug Administration for a planned Phase 2a clinical trial of its lead candidate, TTX-MC138, to be conducted by Quantum Leap Healthcare Collaborative within the PRE-I-SPY program. The dose-expansion study is expected to enroll up to 45 colorectal cancer patients who have completed standard curative-intent therapy and test positive for circulating tumor DNA (“ctDNA”), a marker associated with minimal residual disease (“MRD”) and cancer recurrence, with the trial planned to begin in the first half of 2026 under the leadership of Dr. Paula Pohlmann of MD Anderson Cancer Center.
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About TransCode Therapeutics
TransCode Therapeutics is a clinical stage company pioneering immuno-oncology and RNA therapeutic treatments for high risk and advanced cancers. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. For more information, visit www.transcodetherapeutics.com
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