TransCode Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the company's Investigational New Drug (IND) application and concluded that the company may proceed with its Phase 1/2 multicenter, open-label, dose-escalation and dose-expansion study of its lead therapeutic candidate, TTX-MC138, in patients with advanced solid tumors. The Phase 1/2 clinical trial includes an initial dose-escalation phase followed by a dose-expansion phase. The dose-escalation portion of the trial is designed to include patients with a variety of metastatic solid cancers.

The primary objective of this phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, certain tumor types will be evaluated based on preliminary results from the dose-escalation phase. The primary objective of the dose-expansion phase is to further evaluate safety as well as tolerability and anti-tumor activity of TTX-MC138 in cancer patients.

The company is committed to defeating cancer through the intelligent design and effective delivery of RNA therapeutics based on its proprietary TTX nanoparticle platform. The company's lead therapeutic candidate, TTX -MC138, is focused on treating metastatic tumors which overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode is developing a portfolio of first-in-class RNA therapeutic candidates designed to overcome the challenges of RNA delivery and thus unlock therapeutic access to a variety of novel genetic targets that could be relevant to treating a variety of cancers.