TransCode Therapeutics (NASDAQ: RNAZ) has begun a Phase 2a dose‑expansion study of its lead RNA oncology candidate, TTX‑MC138, in partnership with the non‑profit Quantum Leap Healthcare Collaborative. The trial will enroll up to 45 patients who have completed curative‑intent therapy for colorectal cancer and are ctDNA‑positive, a biomarker that identifies minimal residual disease (MRD) and predicts recurrence.
TTX‑MC138 is a synthetic RNA molecule that inhibits microRNA‑10b (miR‑10b), a driver of metastasis. In the Phase 1a study, the drug was well tolerated across four dose cohorts, with no dose‑limiting toxicities and evidence of durable clinical benefit, including stable disease lasting beyond 12 months in several patients. The safety profile and target engagement data provide a strong foundation for the next‑stage trial.
The Phase 2a study, scheduled to start in the first half of 2026, is strategically positioned to test whether early intervention in MRD‑positive patients can prevent recurrence. If successful, TTX‑MC138 could become the first preventive therapy for high‑risk colorectal cancer, a field with a 40‑percent recurrence rate within five years. The collaboration with Quantum Leap, known for its adaptive platform trials, adds operational expertise and a robust data infrastructure that can accelerate patient enrollment and biomarker validation.
TransCode’s financial position remains a critical backdrop. The company has a modest cash runway and has recently completed a reverse stock split to meet Nasdaq’s minimum bid price requirement. While the Phase 2a trial will require additional capital, the progression of its lead asset reduces clinical risk and could unlock future funding opportunities, potentially improving the company’s valuation and investor confidence.
Historically, positive clinical data from TransCode’s Phase 1a trial has attracted significant investor attention, with a 39‑percent surge in the company’s market value following the announcement of durable benefit data. Analysts have highlighted the trial’s potential to address a high‑unmet need and the novelty of the miR‑10b inhibition mechanism as key drivers of interest. The partnership with Quantum Leap is viewed as a strategic advantage that may streamline trial execution and enhance data quality.
Management emphasized the significance of the milestone. Dr. Daniel Vlock, TransCode’s consulting clinician, said, “The safety and durable clinical benefit observed in Phase 1a provide the basis for proceeding to Phase 2a. The data are consistent with the drug’s mechanism of action and give us confidence to evaluate efficacy in a larger cohort.” Dr. Laura Esserman, co‑founder of Quantum Leap, added, “Detecting and treating micrometastatic disease before it becomes visible is one of the biggest unmet challenges in cancer, and this collaboration positions us to tackle that challenge.”
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