Prnewswire·2026-02-05 13:04Core Insights - TransCode Therapeutics has submitted an Investigational New Drug (IND) application amendment to the FDA for a Phase 2a clinical trial of its lead candidate TTX-MC138, in collaboration with Quantum Leap Healthcare Collaborative [1][3] Group 1: Clinical Trial Details - The Phase 2a trial will enroll up to 45 patients with colorectal cancer who have completed standard therapy and have positive circulating tumor DNA (ctDNA) markers [2] - The trial aims to evaluate the biological and clinical activity of TTX-MC138 in the minimal residual disease (MRD) setting, which is believed to offer significant opportunities for improving long-term outcomes [2] - The trial is set to begin in the first half of 2026 and will be led by Dr. Paula Pohlmann from MD Anderson Cancer Center [2] Group 2: Collaboration and Program Expansion - The IND submission is a significant step in TransCode's clinical development program, enhancing the potential benefits of TTX-MC138 for patients [3] - The collaboration with Quantum Leap's PRE-I-SPY program marks the first expansion of this platform into colorectal cancer [3][4] - The clinical trial will be conducted at various sites within the PRE-I-SPY Platform Network, which includes members of the National Cancer Center Network [4] Group 3: Company Overview - TransCode Therapeutics is focused on immuno-oncology and RNA therapeutics for high-risk and advanced cancers, with TTX-MC138 targeting metastatic tumors that overexpress microRNA-10b [5] - The company has a portfolio of first-in-class therapeutic candidates aimed at mobilizing the immune system to combat cancer cells [5]