CytoDyn (CYDY) Study update summary

Study background and design

• CLOVER Phase II study in metastatic colorectal cancer enrolled 60 patients, all with advanced, heavily pretreated disease.

• Patients received leronlimab plus Lonsurf and Avastin, randomized to 350 mg or 700 mg doses.

• 100% of screened patients were CCR5 positive, expediting enrollment and broadening eligibility.

• No grade 3/4 adverse events or dose-limiting toxicities attributed to leronlimab.

• Two data safety monitoring board reviews found no safety concerns.

Key efficacy and biomarker findings

• All 19 initial patients showed ctDNA declines, with a median 70% decrease at week 2.

• 68% of 22 patients with RECIST data at week 8 had tumor shrinkage or stable disease.

• ctDNA reductions were observed even in patients with KRAS mutations, typically hard to treat.

• Four patients achieved undetectable ctDNA during follow-up, three on the lower dose.

• Numeric increases in PD-L1 were observed in most patients, suggesting immune activation.

Clinical and patient-reported outcomes

• Early clinical improvements included reduced pain and improved performance status.

• Some patients returned to work due to improved well-being.

• Repeat biopsies showed decreased tumor cellularity and increased PD-L1 expression.

• Liquid biopsy (ctDNA) provided rapid, sensitive response readouts, often preceding scan changes.

• The backbone regimen alone historically yields low response rates (<6%).