Updated clinical data reinforces evidence of antitumor activity in heavily pretreated patients with advanced solid tumors
- In the 14 efficacy-evaluable patients:
- 71.4% stable disease rate
- 57.1% of patients had disease control through three months of therapy
- 36.7% maintained disease control through six months of therapy
- Three efficacy-evaluable patients remain progression-free at one year
- Exploratory blood RNA-sequencing showed treatment-associated antitumor immune activation and biological features associated with stable disease.
- The primary endpoint of the study was met
- No dose-limiting toxicities were reported across the evaluated dose levels
BOSTON, Sept. 28, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ:RNAZ), a clinical stage company pioneering immuno-oncology and RNA-based therapeutics for the treatment of high risk and advanced cancers, today announced updated clinical data from its Phase 1a clinical trial of TTX-MC138, its novel anti-miR-10b therapeutic candidate, in patients with relapsed or refractory, unresectable locally advanced, or metastatic solid tumors.
At the data cutoff date of September 1, 2026, 10 of 14 efficacy-evaluable patients, or 71.4%, achieved stable disease as their best overall response by investigator assessment. In the context of a first-in-human, dose-escalation study enrolling patients with advanced, heavily pretreated cancers, the Company believes the consistency, breadth, and durability of disease control observed thus far are promising and warrant continued clinical evaluation.
The disease control rate was 57.1% (95% confidence interval, 28.9% to 82.3%) at Cycle 3 Day 1 and 35.7% (95% confidence interval, 12.8% to 64.9%) at Cycle 6 Day 1.
The durability of responses was also notable. Six of 14 efficacy-evaluable patients were progression-free at three months, three of 14 at six months, and three of 14 at nine and 12 months. Together, these findings show that the efficacy signal was not limited to a single assessment and included prolonged disease control in a subset of patients.
As of the September 1, 2026, a total 98 doses have been administered. In this pre-specified data snapshot, TTX-MC138 demonstrated an acceptable tolerability profile in subjects with advanced solid tumors. No dose-limiting toxicities were reported, no treatment-emergent adverse events led to treatment discontinuation, including the highest evaluated dose level of 4.8 mg/kg. Of note, administration of TTX-MC138 for over a year was well tolerated and not associated with any dose-limiting toxicities.