TransCode Receives FDA Approval to Launch Phase 1/2 Study of TTX-MC138 for Advanced Solid Tumor Patients

April 15, 2024 — TransCode Therapeutics, an RNA oncology company, has received approval from the U.S. Food and Drug Administration (FDA) to commence a Phase 1/2 clinical trial for its lead therapeutic candidate, TTX-MC138. The trial aims to evaluate the safety and potential efficacy of TTX-MC138 in patients with advanced solid tumors that overexpress microRNA-10b, a biomarker associated with metastasis. 

The study will involve an initial dose-escalation phase to assess safety and tolerability, followed by a dose-expansion phase focusing on specific tumor types based on preliminary results. The company anticipates that TTX-MC138 could positively impact patient outcomes across various cancer types, including breast, pancreatic, ovarian, colon, and glioblastoma. Previous animal models have shown significant reductions in metastatic burden and extended survival rates with TTX-MC138 treatment. TransCode Therapeutics is dedicated to developing RNA therapeutics for metastatic diseases using its proprietary TTX nanoparticle platform. The company's focus is on intelligent design and effective delivery to unlock therapeutic access to novel genetic targets for a range of cancers. The FDA's clearance of the IND application for TTX-MC138 is a significant milestone, allowing TransCode to progress its clinical development. 

The company's forward-looking statements include the potential of TTX-MC138 and the expected outcomes of the Phase 1/2 trial. However, these statements are subject to risks and uncertainties, including those related to drug development, clinical trial results, regulatory submissions, intellectual property enforcement, competition, financial conditions, third-party dependencies, and global events such as pandemics. TransCode's financial information and risk factors are detailed in their Annual Report on Form 10-K for 2023 and subsequent SEC filings.

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