CytoDyn Files for FDA Breakthrough Therapy Status for Leronlimab for Metastatic TNBC

CytoDyn Files for FDA Breakthrough Therapy Status for Leronlimab for Metastatic TNBC
CytoDyn has requested breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy leronlimab (PRO 140) as an adjuvant treatment for metastatic triple-negative breast cancer (TNBC). Breakthrough therapy designation is given to medications that have the potential to provide significant advantages over currently available options. It is intended to accelerate the development, review, and approval of treatments for serious or life-threatening conditions. The FDA has already granted the therapy fast track designation for the same indication. Leronlimab is an investigational antibody that blocks CCR5, a protein whose levels are increased in several cancers, including triple-negative breast cancer. Preclinical studies have shown that by blocking CCR5, leronlimab decreased tumor cell migration in the laboratory and in animal models of aggressive breast and prostate cancer — reducing metastasis by more than 98% in a mouse model of breast cancer. It also made cells more sensitive to chemotherapeutic agents. The submission for breakthrough therapy status was based on results from the first patient enrolled in CytoDyn’s Phase 1b/2 clinical trial (
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