TransCode Therapeutics (NASDAQ: RNAZ) has released updated clinical data from its Phase 1a trial of TTX-MC138, an investigational therapy for patients with relapsed or refractory, unresectable locally advanced or metastatic solid tumors. The results, current as of September 1, show that 10 of 14 efficacy-evaluable patients, or 71.4%, achieved stable disease as their best overall response. Six patients remained progression-free at three months, and three continued to be progression-free at six, nine, and twelve months. The disease control rate was 57.1% at Cycle 3 Day 1 and 35.7% at Cycle 6 Day 1.
A post-hoc Growth Modulation Index (GMI) analysis found that six of 15 evaluable patients, or 40%, achieved a GMI greater than 1.3, indicating a progression-free interval at least 30% longer than with their immediately preceding therapy. A total of 98 doses had been administered as of September 1, with no dose-limiting toxicities reported and no treatment-emergent adverse events leading to treatment discontinuation, including at the highest evaluated dose of 4.8 mg/kg. Exploratory RNA-sequencing analysis also identified treatment-associated immune effects that the company said support the observed clinical activity, although the small-sample biomarker findings require confirmation in larger studies.
TransCode is evaluating dose-expansion strategies and plans to continue assessing safety, pharmacokinetics, pharmacodynamics, and antitumor activity. The company’s lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a documented biomarker of metastasis. TransCode also has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells.
For investors, the updated data may signal progress in a difficult-to-treat patient population. The absence of dose-limiting toxicities and treatment discontinuations at the highest dose could support further dose escalation or expansion. The GMI results, while based on a small sample, suggest a potential benefit over prior therapies for some patients. However, the exploratory biomarker findings require validation, and the trial remains early-stage.
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