Natera, Inc. and TransCode Therapeutics, Inc. (Nasdaq: RNAZ) announced a strategic collaboration to develop a treatment for colorectal cancer. Under the partnership, TransCode will receive support for enrollment in its Phase 2a colorectal cancer trial of TTX-MC138. Natera, a global leader in cell-free DNA and precision medicine, will leverage its Signatera test to help identify eligible patients. Conversely, TransCode Therapeutics is developing immuno-oncology and RNA-based therapeutics for high risk and advanced cancers.
The colorectal cancer trial will examine TTX-MC138 in patients who have received curative-intent treatment. To be eligible, patients must be positive for molecular residual disease (MRD) on Natera’s Signatera test. They also must not show evidence of disease on radiographs.
Both companies hope to partner with each other to identify the right patients faster. Also the partnership aims to facilitate patient identification at clinical trial sites. Such efforts could also help in the quality of the study’s enrollment, and help improve enrollment timelines.
“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.”
Addressing the Risk of Colorectal Cancer Recurrence
Patients participating in the study face a significant risk of cancer recurrence. However, no approved therapies currently address MRD-positive patients who remain disease-free on imaging. This gap highlights the need for new treatment approaches in colorectal cancer care.
TTX-MC138 aims to address this unmet medical need by targeting cancer earlier in its progression. The therapy focuses on patients who show molecular evidence of residual disease despite having no visible disease on imaging. Therefore, the colorectal cancer trial could contribute to research into earlier intervention strategies.
His statement highlights the importance of detecting molecular signs of cancer recurrence before conventional imaging identifies visible disease. Moreover, earlier identification could help researchers explore treatment options for patients at elevated risk.
Signatera Testing to Support Patient Enrollment
Natera will use its Signatera MRD testing capabilities to support the identification of eligible participants. The test will help identify patients who meet the study’s molecular residual disease criteria. Consequently, researchers aim to connect suitable patients with the investigational treatment more efficiently.
The collaboration also reflects growing interest in MRD-guided approaches to cancer treatment. These strategies help researchers evaluate molecular evidence of residual disease after treatment. In addition, they may support clinical research focused on identifying patients who face a higher risk of recurrence.
“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.”
The companies expect their collaboration to support patient identification for the ongoing study. Furthermore, their approach combines molecular residual disease testing with the development of an investigational RNA-based cancer therapy.
PRE-I-SPY Platform Expands into Colorectal Cancer
Quantum Leap Healthcare Collaborative is conducting TransCode’s study through its PRE-I-SPY program. The program serves as a venue for innovative oncology clinical trials. Interestingly, this study is the first foray of PRE-I-SPY beyond breast cancer into colorectal cancer. PRE-I-SPY builds on the clinically validated I-SPY trial model. This is extending the approach to early feasibility testing to speed up the path of biologically targeted treatments to curative-intent treatment settings. This provides an opportunity to evaluate promising therapies in clinical research.
TTX-MC138 is a first-in-class therapeutic candidate targeting the inhibition of microRNA-10b (miR-10b). This biomarker has been widely associated with the development and progression of metastatic cancers, including colorectal cancer. TTX-MC138 targets a biological mechanism linked to cancer progression by targeting miR-10b. However, the investigational therapy is still under clinical evaluation and the trial will determine the potential of the therapy in the selected patient population.
Thus, the colorectal cancer trial brings together molecular residual disease testing, patient enrollment strategies and RNA-based therapeutic research. This could help researchers explore treatment options for patients who are at risk of recurrence after initial therapy. More information regarding the clinical study can be found on ClinicalTrials.gov under identifier NCT05868226.
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News Source: Businesswire.com
