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Only two documented cases of HIV cure have been reported, the Berlin and London patients, who both were cured via allogeneic stem cell transplants from CCR5-deficient donors. In pre-clinical studies, Leronlimab has demonstrated the ability to mimic CCR5 deficiency by binding to CCR5 receptors, thereby preventing HIV from interacting with its primary co-receptor. In recognition of the Berlin patient, Timothy Brown, and his impact on HIV cure, CytoDyn has committed to exploring if Leronlimab can contribute to development of an HIV cure.
Our lead product, Leronlimab (PRO 140), belongs to a new class of HIV/AIDS therapeutics that protects healthy cells from viral infection. HAART, the current standard of care for HIV, waits until the virus enters the cell and begins replicating before it attacks the virus.
CytoDyn has successfully completed a Phase 3 pivotal trial with Leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients meeting its primary endpoint. 81% of patients completing trial achieved HIV viral load suppression of < 50 cp/mL.
CytoDyn has submitted the first two sections (non-clinical and CMC) of its Biological License Application (BLA) for that indication and our team is working diligently on the clinical section. The FDA previously granted Fast Track Designation (FTD) and granted Rolling Review for Leronlimab (PRO140), which facilitates frequent interactions with the FDA review team. The Rolling Review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on FDA review until all three sections are completed and filed.
CytoDyn also completed an investigative monotherapy trial for HIV.