TLDR
- RNAZ jumps as TransCode files IND amendment for Phase 2a colorectal trial
- TransCode expands PRE-I-SPY into colorectal cancer with TTX-MC138 study
- RNAZ holds gains as Phase 2a trial targets ctDNA-positive MRD patients
- IND amendment clears path for TTX-MC138 dose-expansion trial in 2026
- TransCode sets Phase 2a plan with Quantum Leap and MD Anderson lead site
TransCode (RNAZ) shares trade at $10.80, up 23.29%, after sharp swings that left the stock holding gains above $10. The move follows news tied to an FDA submission and a new colorectal cancer trial plan.
TransCode Therapeutics, Inc., RNAZ
TransCode submitted an FDA Investigational New Drug amendment for a planned Phase 2a study of TTX-MC138. Quantum Leap Healthcare Collaborative will run the trial within its PRE-I-SPY clinical platform. The submission also marks PRE-I-SPY’s first expansion into colorectal cancer.
The planned Phase 2a dose-expansion portion targets colorectal cancer patients after curative-intent standard therapy. It will enroll up to 45 patients with positive circulating tumor DNA markers. Therefore, the trial centers on a population linked to recurrence risk and minimal residual disease.
Trial design targets ctDNA-positive MRD after standard therapy
The study focuses on circulating tumor DNA because research links it to prognosis and relapse risk. Positive ctDNA can signal minimal residual disease that persists after initial treatment. As a result, the trial positions intervention at an earlier clinical window than metastatic care.
The Phase 2a trial is scheduled to begin in the first half of 2026. Dr. Paula Pohlmann of MD Anderson Cancer Center will serve as principal investigator. Multiple PRE-I-SPY network sites will participate in patient enrollment and trial operations.
Sites include several centers associated with major cancer research networks. The program also plans engagement with the Colorectal Cancer Alliance to support outreach. Trial documentation appears on a public registry under identifier NCT05868226.
Company background and pipeline focus shape the expansion
TransCode operates as a clinical-stage developer in immuno-oncology and RNA-based therapeutics. The company positions TTX-MC138 as its lead therapeutic candidate. It targets metastatic tumors that overexpress microRNA-10b, a biomarker linked to metastasis.
TTX-MC138 now moves into a colorectal cancer setting tied to ctDNA-defined minimal residual disease. This approach aligns trial selection with measurable biomarkers and recurrence risk. The program seeks early signals of biological and clinical activity in a focused patient group.
TransCode also maintains additional therapeutic candidates designed to activate immune responses against cancer cells. The company frames its portfolio around first-in-class RNA and immune-focused mechanisms. With the IND amendment submitted, TransCode advances a near-term clinical step tied to its lead asset.
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