TransCode Therapeutics Announces First Patients Treated in Phase 1 Clinical Trial With First-in-Class Lead Therapeutic Candidate


TransCode Therapeutics, Inc. recently announced dosing of the first two patients in its Phase 1 clinical trial with its lead candidate, TTX-MC138. Several additional patients have been screened for enrollment in the trial, a multicenter, open-label, dose-escalation and dose-expansion study of TTX-MC138.

“We are thrilled to announce the first two patients were administered TTX-MC138 in our Phase 1 clinical trial. This is a significant milestone for the TTX-MC138 clinical development program with our novel approach to treating metastatic cancers,” said Sue Duggan, Senior Vice President of Operations, at TransCode. Duggan added, “TTX-MC138 is a first-in-class therapeutic candidate that showed evidence of delivery to metastatic lesions in our Phase 0 clinical trial.”

TransCode believes that TTX-MC138 is the first therapeutic candidate in clinical development designed to specifically target a molecule responsible for metastatic disease across multiple indications and irrespective of the site of metastasis. It has the potential to positively affect patient outcomes in a range of cancers, including breast, pancreatic, ovarian, colon, lung and others. Successful clinical development of TTX-MC138 could represent a breakthrough approach to effectively treating patients with metastatic cancer.

The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study, designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation phase followed by a dose-expansion phase. The primary objective of the dose-escalation phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase. Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).

TransCode is a clinical-stage oncology company focused on treating metastatic disease. 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 other 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.