TransCode Therapeutics (NASDAQ: RNAZ) has announced additional positive results from its Phase 1a dose-escalation trial evaluating TTX-MC138, an investigational microRNA-10b inhibitor for advanced cancer. The study met its primary safety endpoint, with no dose-limiting toxicities observed across 16 patients who received a total of 86 doses. The company reported durable disease stabilization in multiple patients, including three participants who remain on treatment after 14, 16, and 21 cycles, supporting the advancement of TTX-MC138 into Phase 2a clinical development.
Among 14 evaluable patients, nine (64%) achieved stable disease lasting at least six months based on RECIST criteria. TransCode also reported pharmacokinetic data demonstrating 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. The company said the results 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.
TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, a well-documented biomarker of metastasis. TransCode Therapeutics is a clinical-stage company pioneering immuno-oncology and RNA therapeutic treatments for high-risk and advanced cancers. The company’s lead candidate focuses on treating metastatic tumors that overexpress microRNA-10b, and it also has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells.
These results are significant because they offer hope for patients with advanced cancers who have limited treatment options. The durable disease stabilization observed in multiple patients, including one with metastatic thyroid cancer, suggests that TTX-MC138 could potentially alter the course of the disease. The lack of dose-limiting toxicities also indicates a favorable safety profile, which is crucial for a patient population that often cannot tolerate aggressive therapies.
The advancement to Phase 2a marks a critical step toward validating the efficacy of this novel approach. If successful, TTX-MC138 could become a targeted therapy for metastatic tumors, addressing a significant unmet medical need. Investors and the medical community will be watching closely as the program progresses.
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