On October 13, 2026 Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, and 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, reported a strategic collaboration in colorectal cancer (CRC).
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The collaboration will support enrollment for TransCode’s Phase 2a trial evaluating TTX-MC138 in patients with CRC. Patients will be eligible for enrollment if they have completed curative-intent therapy and remain positive for molecular residual disease (MRD), as detected by Natera’s Signatera test, with no radiographic evidence of disease. The collaboration aims to surface patient populations who meet the trial’s MRD-positive eligibility criteria more efficiently, streamline site-level identification, and optimize the pace and quality of enrollment for the study.
The patient population studied in the trial faces a significant risk of recurrence, yet there are currently no approved therapies for MRD-positive patients who remain disease-free on imaging. TTX-MC138 works to address this critical treatment gap by intervening earlier in the disease course.
"Identifying recurrence of colorectal cancer before it becomes clinically apparent, when it is potentially much easier to treat, is one of the central challenges in developing breakthrough therapies that help to answer unmet medical needs for this setting," said Philippe P. Calais, PharmD, Ph.D., chairman and CEO, TransCode Therapeutics. "Leveraging one of the most established MRD testing footprints will help us identify high-risk patients faster and potentially intervene earlier, advancing a new treatment paradigm focused on addressing cancer at the molecular residual disease stage before recurrence becomes clinically apparent."
"We are pleased to collaborate with TransCode to bring the power of Signatera to bear on one of the most difficult problems in clinical development: finding the right patients at the right time," said Eric Matthews, general manager, biopharma, Natera. "By identifying Signatera MRD-positive patients for enrollment, we aim to support the advancement of this promising therapy for patients and build on the growing clinical and scientific momentum supporting MRD-guided strategies in colorectal cancer."
TransCode’s study is being conducted by Quantum Leap Healthcare Collaborative within its PRE-I-SPY program, a leading platform for innovative oncology clinical trials. This trial represents the program’s first expansion beyond breast cancer into CRC. The PRE-I-SPY platform extends the clinically validated I-SPY trial model into early feasibility testing to accelerate biologically targeted therapies into the curative-intent setting. TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b (miR-10b), a biomarker widely linked to the emergence and progression of metastatic cancers, including CRC. More information can be found at clinicaltrials.gov (NCT05868226).
(Press release, Natera, OCT 13, 2026, View Source [SID1234673368])