Natera, CytoDyn to Use ctDNA Testing in Metastatic Colorectal Cancer Drug Study
Natera's Signatera assay will analyze tumor DNA dynamics in CytoDyn's Phase II trial of leronlimab.
Natera and CytoDyn have collaborated to evaluate circulating tumor DNA (ctDNA) dynamics in patients enrolled in CytoDyn’s Phase 2 study of leronlimab, an antibody therapy, in metastatic colorectal cancer (mCRC).
Under the agreement, announced June 4, Natera will apply its Signatera assay — a tumor-informed, sequencing-based test for minimal residual disease (MRD) — to clinical samples from CytoDyn’s CLOVER study, which is evaluating leronlimab in combination with trifluridine/tipiracil and bevacizumab in previously treated mCRC patients.
“Signatera has become an increasingly important tool in precision oncology and clinical development,” CytoDyn CEO Jacob Lalezari said in a statement. “Through this collaboration, we expect to gain valuable insights into ctDNA response kinetics and disease progression that may help guide future development strategies for leronlimab in colorectal cancer and potentially other solid tumor indications.”
Financial details of the deal were not disclosed.
Natera will also conduct real-world data analyses using its oncology database, which the company says contains more than 2 million plasma timepoints alongside clinical and imaging records. By combining MRD testing data with electronic medical record information, Natera aims to generate analyses of patient populations, treatment patterns, ctDNA response rates, and response dynamics across clinical settings.
The companies said the collaboration is intended to generate molecular insights that could inform future development of leronlimab, including clinical trial design, biomarker-driven patient selection, and translational research.