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TransCode Therapeutics Announces Safety Review Committee Approval of Opening Third Cohort and Preliminary Results from First Cohort in Phase 1 TTX-MC138 Clinical Trial
RNAZTransCode Therapeutics(RNAZ) Prnewswire·2024-12-18 13:00

Core Viewpoint - TransCode Therapeutics has received approval to open the third cohort of its Phase 1 clinical trial for TTX-MC138, a therapeutic candidate targeting microRNA-10b, after a favorable safety review of Cohort 2 data [1][3] Group 1: Clinical Trial Progress - The Safety Review Committee (SRC) has unanimously approved the opening of Cohort 3 based on the safety data from Cohort 2, which reported no significant safety or dose-limiting toxicities [1][3] - New patients are currently being evaluated for eligibility in Cohort 3, with the dose for this cohort being approximately double that of Cohort 2 [1] - Several patients from Cohort 1 and Cohort 2 remain on study for continued treatment, with ongoing analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data [2] Group 2: Pharmacokinetic and Pharmacodynamic Data - Cohort 1 data suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results, showing 66% inhibition of miR-10b at 24 hours post-infusion [2] - The concentration of TTX-MC138 in blood plasma was found to be higher than in nonclinical studies, indicating a favorable pharmacokinetic profile [2] Group 3: About TTX-MC138 - TTX-MC138 is a first-in-class therapeutic candidate targeting microRNA-10b, which is believed to drive metastatic disease [4] - The Phase 0 clinical trial provided evidence of the drug's delivery to metastatic lesions and pharmacodynamic activity, even at microdoses, suggesting a broad therapeutic window [4] Group 4: Trial Design - The Phase 1 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 includes an initial dose-escalation phase followed by a dose-expansion phase, with the primary objective of assessing safety and tolerability [5]