CytoDyn Highlights CLOVER Progress, Early ctDNA Declines in Colorectal Cancer

Key Points

• 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 OTCMKTS: CYDY 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 reportedly declined 97% after eight weeks, while tumor volume in liver scans declined 21%. He said the company intends to correlate ctDNA changes with clinical outcomes as the study progresses.

The Natera collaboration also gives CytoDyn access to a database of 144,000 colorectal cancer patients, including a subset with ctDNA data for treatment with the LONSURF and bevacizumab backbone. Hoffman said the company expects to use those real-world data to assess leronlimab’s contribution when added to the standard regimen.

Company Sees Opportunity Against Existing Third-Line Results

Hoffman cited the SUNLIGHT study of LONSURF plus bevacizumab, which reported a 6.1% objective response rate, with no complete responses. He also referenced a subsequent real-world meta-analysis that he said found an objective response rate closer to 2.7%.

CytoDyn’s stated objective response-rate target for CLOVER is more than 10%. Hoffman said the company believes its early data support optimism about exceeding the 6.1% result reported in SUNLIGHT, though he noted CLOVER includes a more heavily pretreated population. He said 52% of CLOVER participants had received more than three prior lines of therapy, compared with 13% in SUNLIGHT.

The company plans to present additional clinical and ctDNA findings at the European Society for Medical Oncology meeting in October, followed by further clinical and biomarker updates at ASCO GI in San Francisco in January 2027.

Breast Cancer and Additional Studies

In triple-negative breast cancer, Hoffman discussed retrospective data involving patients whose PD-L1 levels increased after treatment with leronlimab and who subsequently received a checkpoint inhibitor. He said five of five such patients were alive more than five years later, with three reporting no evidence of disease. Hoffman contrasted those results with 23 patients who did not upregulate PD-L1 or receive a checkpoint inhibitor and had died by the time of the analysis.

CytoDyn is considering a dose-escalation and contribution-of-component study through PRE-I-SPY, as well as a neoadjuvant study in HER2-negative breast cancer. The company also expects a City of Hope Phase I study, called CHAMP, to begin in the third or fourth quarter of 2026 for colorectal cancer patients in earlier treatment lines.

Hoffman said CytoDyn plans to engage the FDA in the second half of 2026 regarding potential expedited pathways, including breakthrough therapy designation, fast track designation or an accelerated pathway. He added that the company is discussing potential partnerships and plans to attend the BIO-Europe partnering conference in November.

About CytoDyn (OTCMKTS:CYDY)

CytoDyn Inc is a biotechnology company focused on developing leronlimab, an investigational monoclonal antibody designed to target and block CCR5, a receptor involved in immune-cell signaling. The company is headquartered in Vancouver, Washington.

Leronlimab has been studied as a potential treatment for HIV infection and other diseases in which CCR5 may play a role. CytoDyn has also explored the compound in oncology and inflammatory conditions, including certain forms of cancer and other immune-related disorders.

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