TransCode Therapeutics (NASDAQ: RNAZ) has released updated clinical data from its Phase 1a trial of TTX-MC138 in patients with relapsed or refractory, unresectable locally advanced or metastatic solid tumors. The results, as of September 1, showed that 10 of 14 efficacy-evaluable patients, or 71.4%, achieved stable disease as their best overall response. Six patients were progression-free at three months, and three remained progression-free at six, nine, and 12 months. The disease control rate was 57.1% at Cycle 3 Day 1 and 35.7% at Cycle 6 Day 1. These findings are particularly significant for a patient population that has exhausted standard treatment options, as stable disease can translate into prolonged survival and improved quality of life.
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. This suggests that TTX-MC138 may slow tumor progression compared to prior treatments, a critical consideration in advanced cancers where rapid progression is common. The GMI metric is increasingly recognized as a valuable tool in early-phase oncology trials to assess potential efficacy.
Safety data were also encouraging. 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. The absence of dose-limiting toxicities is a positive signal for the drug's tolerability, which is essential for maintaining patient adherence and enabling combination with other therapies. Exploratory RNA-sequencing analysis identified treatment-associated immune effects that support the observed clinical activity, though the company noted that the small-sample biomarker findings require confirmation in larger studies. Understanding the immune mechanisms could guide future development and patient selection.
TransCode is evaluating dose-expansion strategies and plans to continue assessing safety, pharmacokinetics, pharmacodynamics, and antitumor activity. For a clinical-stage company, these data provide a foundation for advancing TTX-MC138 into later-stage trials and potentially attracting partnerships or investment. The full press release can be viewed at https://ibn.fm/mIBZR. For ongoing updates, investors can visit the company's newsroom at https://ibn.fm/RNAZ.
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