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CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer at AACR Annual Meeting 2026

  • CytoDyn Inc. presented early clinical & biomarker data from an ongoing Phase 2 study of leronlimab combined with TAS-102 & bevacizumab for metastatic colorectal cancer (mCRC) at the AACR Annual Meeting 2026.
  • CCR5 expression was detected in 100% of the 33 pre-screened patients with evaluable samples, validating CCR5 as a therapeutic target in mCRC.
  • Evaluable patients (N=19) showed rapid & substantial declines in circulating tumor DNA (ctDNA) with a median reduction of approximately 70% by week 2.
  • The combination regimen was well tolerated with no leronlimab-related dose-limiting toxicities (DLTs) observed, & dosing escalation to 700 mg is currently underway.
  • The study continues to enroll patients to address the unmet need for effective treatments in heavily pretreated mCRC populations.
  • Researchers utilized real-time liquid biopsy biomarkers including circulating tumor cells, ctDNA, & cancer-associated macrophage-like cells to assess tumor microenvironment modulation.
  • The findings support CCR5 inhibition as a strategy to enhance immune engagement & overcome treatment resistance in solid tumors.