CytoDyn Highlights CLOVER Progress, Early ctDNA Declines in Colorectal Cancer

CytoDyn Highlights CLOVER Progress, Early ctDNA Declines in Colorectal Cancer

CLOVER enrollment is complete: CytoDyn’s Phase II trial is evaluating leronlimab with LONSURF and Avastin in third-line metastatic colorectal cancer. Safety reviews have raised no concerns, and the company is adding a pembrolizumab salvage-treatment arm. Early ctDNA results were encouraging: Among 28 patients, median circulating tumor DNA declined 86% after as little as two weeks, including approximately 90% in the 700-milligram arm. CytoDyn plans to compare these biomarker changes with clinical outcomes and present additional data at upcoming oncology conferences. CytoDyn is targeting an objective response rate above 10%: Management believes this could exceed the 6.1% response rate reported for the LONSURF–Avastin regimen in the SUNLIGHT study, though CLOVER patients were more heavily pretreated. The company is also advancing breast-cancer studies and exploring FDA expedited-designation pathways.

CytoDyn Chief Financial Officer Robert E. Hoffman outlined the company’s clinical-development plans for leronlimab, a CCR5-targeting humanized monoclonal antibody being studied in metastatic colorectal cancer, triple-negative breast cancer and other solid tumors. Speaking at the Life Sciences Investor Forum, Hoffman described CytoDyn as a clinical-stage oncology company and said its lead program is the Phase II CLOVER study in third-line metastatic colorectal cancer. The trial is evaluating leronlimab in combination with LONSURF and Avastin, or bevacizumab, which Hoffman characterized as the current standard-of-care treatment backbone for those patients.

CLOVER Enrollment Completed, Safety Reviews Continue According to Hoffman, CLOVER dosed its first patient in June 2025 and completed enrollment in April 2026, in less than a year. He said the company’s contract research organization indicated enrollment moved quickly, while physicians provided anecdotal reports that some patients felt better after several weeks and required less pain medication. The study’s primary endpoint is to evaluate the efficacy and safety of leronlimab combined with LONSURF and Avastin. Secondary and exploratory measures include safety and tolerability, circulating tumor DNA, objective response rate, partial responses, stable disease and progression-free survival. Hoffman said the Data Safety Monitoring Board had met three times, including once to permit the opening of a 700-milligram dosing arm. He said no safety concerns were identified in those meetings. CytoDyn expects another DSMB meeting in November. The company also filed an amendment to CLOVER that is being implemented at clinical sites. The amendment provides an extension for stable patients and a salvage-treatment rollover arm for patients with documented progression. That arm will combine leronlimab with pembrolizumab, a checkpoint inhibitor. Hoffman said CytoDyn expected the first two patients in the salvage arm to be dosed within weeks.

ctDNA Collaboration With Natera CytoDyn signed a collaboration with Natera in late May 2026 to incorporate circulating tumor DNA testing into its colorectal cancer program. Hoffman said ctDNA testing, sometimes described as a liquid biopsy, can help monitor whether treatment is working and may provide earlier indications of cancer progression or recurrence. In an early readout involving 28 patients tested through Natera’s Signatera Exome platform, Hoffman said the median ctDNA decline was 86% after as little as two weeks. He said declines were approximately 90% in the 700-milligram arm and 80% in the 350-milligram arm. Hoffman also highlighted a case study from the trial involving a patient treated at City of Hope. The patient’s ctDNA r...