TransCode Therapeutics, Inc. (NASDAQ: RNAZ) has announced the commencement of its Phase 1 clinical trial for TTX-MC138, a first-in-class therapeutic candidate targeting microRNA-10b, a known driver of metastasis in multiple cancers. The first two patients have been dosed, marking a significant step forward in the development of RNA-based therapies for metastatic disease.
The Phase 1 trial (NCT06260774) is a multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers. The trial aims to determine the optimal dose of TTX-MC138 and assess its potential anti-tumor activity.
Targeting microRNA-10b
TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system. It is designed to inhibit microRNA-10b, a regulatory molecule implicated in the emergence and progression of metastatic cancer. Preclinical studies and a Phase 0 clinical trial have demonstrated the ability of TTX-MC138 to reach metastatic lesions and exert pharmacodynamic activity, even at low doses.
Sue Duggan, Senior Vice President of Operations at TransCode, stated, "We are thrilled to announce the first two patients were administered TTX-MC138 in our Phase 1 clinical trial...TTX-MC138 is a first-in-class therapeutic candidate that showed evidence of delivery to metastatic lesions in our Phase 0 clinical trial."
Trial Design and Objectives
The Phase 1 trial consists of two phases: a dose-escalation phase and a dose-expansion phase. The primary objective of the dose-escalation phase is to evaluate the safety and tolerability of escalating doses of TTX-MC138. The dose-expansion phase will further evaluate the safety, tolerability, and anti-tumor activity of TTX-MC138 in selected tumor types based on preliminary results from the dose-escalation phase.
Metastatic Cancer and Unmet Needs
Metastatic cancer remains a significant challenge in oncology, with limited treatment options available for many patients. TransCode believes that TTX-MC138 has the potential to positively affect patient outcomes in a range of cancers, including breast, pancreatic, ovarian, colon, and lung cancers. Successful clinical development of TTX-MC138 could represent a breakthrough approach to effectively treating patients with metastatic cancer.
Initial Cohort Dosing Complete
TransCode has also announced the completion of initial dosing for all patients in the first cohort of the Phase 1a dose-escalation trial. Patients remain on the study for continued treatment with TTX-MC138. No significant safety or dose-limiting toxicities have been reported to date.
Duggan added, "The rapid enrollment of the first cohort is extremely encouraging. The absence of dose limiting toxicities thus far supports continued dosing and assessment of TTX-MC138 for safety and tolerability."
