CytoDyn Seeks Preliminary FDA Meeting on Leronlimab’s Breakthrough Therapy Status

CytoDyn Seeks Preliminary FDA Meeting on Leronlimab’s Breakthrough Therapy Status
After a recommendation from the U.S. Food and Drug Administration (FDA), CytoDyn is planning to ask the regulatory agency for a preliminary meeting to discuss the granting of breakthrough therapy status to leronlimab for the treatment of metastatic triple-negative breast cancer (TNBC). Breakthrough therapy designation is intended to accelerate the development, review, and approval of treatments for serious or life-threatening conditions. If granted, it will follow leronlimab's inclusion in FDA's fast track program for the same indication. "The FDA recommendation for a meeting on CytoDyn’s [breakthrough therapy designation] application is a tremendous opportunity to further discuss the mechanism of action and to summarize the promising results from patients enrolled following the submission of the application," Bruce Patterson, MD, CEO and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, said in a press release. Leronlimab is a human antibody designed to target the CCR5 surface receptor protein, whose levels are increased in several cancers, including triple-negative breast cancer. In the tumor environment, CCR5 is found particularly in immunosuppressive cells — tumor-associated macrophages and regulatory T-cells (Tregs) — that help the tumor escape the immune system, and in cancer cells that acquired the ability to migrate to distant regions of the body. Preclinical studies have shown that by blocking CCR5, leronlimab stopped breast cancer cells from migrating — reducing metastasis by more than 98% in a mouse model — and made them more sensitive to chemotherapeutic agents. The submission for breakthrough therapy status was based on results from CytoDyn’s Phase 1b/2 clinical trial (NCT03838367), which is testing a comb
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