Natera, CytoDyn Partner in Colorectal Cancer Study

Natera Inc. and CytoDyn Inc. have entered a strategic collaboration aimed at generating molecular and real-world data to support CytoDyn’s metastatic colorectal cancer program, expanding the use of Natera’s Signatera assay in the CLOVER Phase 2 study.

Under the agreement, Natera will analyze samples from CytoDyn’s CLOVER trial in patients with metastatic colorectal cancer, using Signatera—its personalized molecular residual disease assay—to track circulating tumor DNA dynamics and molecular response patterns tied to leronlimab treatment.

Natera will also provide customized real-world data analyses drawn from its oncology database, combining molecular-response information from its MRD platform with curated electronic medical record data. The companies said the resulting dataset is expected to offer a clearer view of patient populations, treatment patterns, ctDNA response rates and disease progression, with potential implications for trial design, biomarker-based patient selection and future translational research.

The collaboration comes after CytoDyn completed enrollment in the CLOVER study, which is evaluating leronlimab in combination with trifluridine/tipiracil, also known as TAS-102, and bevacizumab in previously treated metastatic colorectal cancer patients. The companies said the effort is expected to complement ongoing translational and biomarker analyses from the trial.

CytoDyn CEO Jacob Lalezari said the company expects the collaboration to add to its understanding of treatment response in colorectal cancer. “Signatera has become an increasingly important tool in precision oncology and clinical development,” he said. “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.”

Natera said the partnership will draw on the scale of its oncology data platform to help inform development decisions. “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, VP, 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.”