Collaboration Advances ctDNA-Guided Development in Metastatic Colorectal Cancer

(Austin, TX, USA) and CytoDyn Inc. (Vancouver, WA, USA) announced a strategic collaboration focused on metastatic colorectal cancer (mCRC). Under the agreement, Natera will evaluate circulating tumor DNA (ctDNA) from clinical trial samples collected in CytoDyn’s CLOVER Phase 2 study. The trial is assessing leronlimab, a humanized monoclonal antibody targeting the CCR5 receptor, for patients with previously treated mCRC in combination with trifluridine/tipiracil (TAS-102) and bevacizumab.

The collaboration centers on Signatera, Natera’s personalized assay for detection of molecular residual disease (MRD). Signatera will be used to evaluate ctDNA dynamics and molecular response patterns associated with leronlimab treatment. Natera will also deliver customized real-world data (RWD) analyses using its proprietary oncology database, described as the largest multi-timepoint early- and late-stage oncology dataset with more than 2 million plasma timepoints and enriched clinical and imaging records.

Natera develops cell-free DNA–based testing and precision medicine tools across oncology, women’s health, and organ health, with its molecular diagnostics portfolio supported by more than 400 peer-reviewed publications. CytoDyn is a clinical-stage oncology company advancing leronlimab, a humanized monoclonal antibody that targets the CCR5 receptor, an immune system regulator implicated in cancer as well as infectious and autoimmune diseases.

By integrating MRD testing results with curated electronic medical record (EMR) data, the multimodal dataset enables analyses of patient populations, treatment patterns, ctDNA response rates, and response dynamics across diverse clinical settings. These analyses are expected to generate insights into molecular response and disease progression. The effort aims to inform future clinical development of leronlimab, including study design, biomarker-driven patient selection strategies, and translational research.

The collaboration follows completion of enrollment in the CLOVER study. It is also expected to complement ongoing translational and biomarker analyses from the trial that are aimed at further characterizing treatment response and informing subsequent development strategies. The companies indicated that the combined approach of longitudinal MRD assessment and linked clinical data is intended to provide real-world molecular insights specific to mCRC.

“Signatera has become an increasingly important tool in precision oncology and clinical development,” said Jacob Lalezari, M.D., chief executive officer, CytoDyn. “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.”

“We are pleased to partner with CytoDyn and provide their team with insights derived from one of the largest and most comprehensive real-world molecular oncology data platforms,” said Matt Love, vice president, biopharma data & AI partnering, Natera. “Our platform enables biopharma partners to better understand disease biology, treatment response, and patient outcomes, helping inform key development decisions throughout the drug development lifecycle.”

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