Core Insights - TransCode Therapeutics has received unanimous approval from the Safety Review Committee (SRC) to open the fourth cohort of its Phase I clinical trial for TTX-MC138, a first-in-class RNA therapeutic targeting metastatic cancers [1][3] - The fourth cohort will receive a dose approximately fifty percent higher than that administered in the third cohort, indicating a planned escalation in dosage [1][2] - The trial has shown no dose limiting toxicities or disease progression in the first three cohorts, with six out of nine patients continuing treatment [2][7] Company Overview - TransCode Therapeutics is focused on developing RNA therapeutics for cancer treatment, particularly targeting metastatic diseases through its proprietary TTX nanoparticle platform [8] - TTX-MC138 specifically targets microRNA-10b, which is associated with metastatic disease, and has shown promising results in preclinical and early clinical trials [4][8] Clinical Trial Details - The Phase I clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial consists of an initial dose-escalation stage followed by a dose-expansion stage, with the primary objective of assessing safety and tolerability [5] - Preliminary pharmacokinetic (PK) and pharmacodynamic (PD) analyses from Cohorts 1 and 2 are consistent with preclinical results, suggesting an efficacious dose range of 0.8-1.6 mg/kg [2][7]
TransCode Therapeutics Announces Safety Review Committee Approval to Open Fourth Cohort in Phase I/II Clinical Trial