TransCode Therapeutics Announces First Patients Treated with First-in-Class Therapeutic Agent in Phase 1 Clinical Trial Page 1

• Two patients dosed; several additional patients screened for participation
• Study to evaluate the 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 release and pharmacodynamic activity in previous first-in-human Phase 0 clinical trial of 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 therapies, today announced the dosing of the first two patients in its Phase 1 clinical trial of its lead candidate, TTX-MC138. Multiple additional patients have been screened for enrollment in the study, a multicenter, open-label, dose-escalation and dose-expansion study of TTX-MC138.

“We are pleased to announce that the first two patients have received TTX-MC138 in our Phase 1 clinical trial. This is an important milestone for the TTX-MC138 clinical development program with our novel approach to the treatment of metastatic cancers,” said Sue Duggan, Senior Vice President of Operations at TransCode. Duggan added, “TTX-MC138 is a first-in-class therapeutic candidate that demonstrated evidence of administration to metastatic lesions in our Phase 0 clinical trial.”

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

About the process
The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study designed to generate critical data to support the evaluation of the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers. Although not an endpoint, the study may provide early evidence of clinical activity of TTX-MC138. The study includes 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 increasing dose levels of TTX-MC138. The dose-expansion phase will further evaluate the safety, tolerability, and antitumor activity of TTX-MC138 in select tumor types selected based on preliminary results from the dose-escalation phase.