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

• Two patients dosed; several additional patients screened for enrollment
• Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer
• TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers
• Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior first-in-human Phase 0 clinical trial with radiolabeled TTX-MC138

BOSTON, Sept. 17, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today 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,” commented 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.

About the Trial
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.