TransCode Therapeutics Reports Positive Phase 1a Results for TTX-MC138, Paving Way for Phase 2a Trial
TransCode Therapeutics announced positive Phase 1a results for its investigational microRNA-10b inhibitor TTX-MC138, showing durable disease stabilization and no dose-limiting toxicities, supporting advancement to Phase 2a clinical development.
TransCode Therapeutics (NASDAQ: RNAZ) has reported additional positive results from its Phase 1a dose-escalation trial of TTX-MC138, an investigational microRNA-10b inhibitor for advanced cancer, moving the program closer to Phase 2a development. The study met its primary safety endpoint with no dose-limiting toxicities observed across 16 patients who received a total of 86 doses, according to a company announcement.
The results showed durable disease stabilization in multiple patients, including three participants who remain on treatment after 14, 16, and 21 cycles. Among 14 evaluable patients, nine (64%) achieved stable disease lasting at least six months based on RECIST criteria. Pharmacokinetic data demonstrated drug bioavailability consistent with preclinical findings. Notably, a metastatic thyroid cancer patient experienced a significant decline in thyroglobulin levels and has maintained stable disease for 12 months.
These findings support the selection of a recommended Phase 2a dose of 4.8 mg/kg and provide a rationale for continued clinical development in patients with limited treatment options. The company highlighted that TTX-MC138 targets microRNA-10b, a unique biomarker of metastasis, which could address a significant unmet need in advanced cancers.
TransCode Therapeutics is a clinical stage company focused on immuno-oncology and RNA therapeutic treatments for high-risk and advanced cancers. The company's lead candidate, TTX-MC138, is designed to treat metastatic tumors that overexpress microRNA-10b. In addition, TransCode has a portfolio of other first-in-class therapeutic candidates aimed at mobilizing the immune system to recognize and destroy cancer cells.
For more information, visit the company's newsroom at https://ibn.fm/RNAZ. The full press release is available at https://ibn.fm/4WzoX.
The implications of these results are significant for patients with advanced cancers who have limited treatment options. TTX-MC138's ability to induce durable stable disease and its favorable safety profile suggest it could offer a new therapeutic avenue. The advancement to Phase 2a will further evaluate efficacy and bring the therapy closer to potential regulatory approval.