TransCode Therapeutics Successfully Completes Initial Dosing of Patients in Cohort 4 of Phase 1a Clinical Trial; No Dose Limiting Toxicities Reported

Core Viewpoint - TransCode Therapeutics is advancing its Phase 1a clinical trial for TTX-MC138, a novel RNA therapeutic aimed at treating metastatic cancers, with positive safety and pharmacokinetic data supporting further development [1][3][5]. Group 1: Clinical Trial Progress - The third patient in Cohort 4 has received the initial dose of TTX-MC138, with all cohorts having at least three patients dosed [1]. - A total of 15 patients have been treated across four dose levels (0.8 mg/kg to 4.8 mg/kg), with no significant safety or dose-limiting toxicities reported [2][8]. - Ten patients remain on study, receiving doses every 28 days, with two patients showing stable disease after seven doses over approximately seven months [2][8]. Group 2: Safety and Efficacy Data - Preliminary pharmacokinetic (PK) and pharmacodynamic (PD) analyses indicate a predictable dose-response relationship, with evidence of miR-10b target engagement at 24 hours post-infusion [2][4][8]. - The observed tolerability profile supports the advancement of the trial into the Phase 1b dose expansion stage to further evaluate safety and potential anti-tumor activity [3]. Group 3: About TTX-MC138 - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of many metastatic cancers, and has shown promising delivery and activity in preclinical studies [4][7]. - The drug candidate has demonstrated a broad therapeutic window, suggesting potential for effective treatment of metastatic tumors [4]. Group 4: Trial Design - The Phase 1 clinical trial is a multicenter, open-label 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 to further assess safety, tolerability, and anti-tumor activity [5].