CytoDyn Files BLA Modules for HIV Therapy

CytoDyn has submitted clinical and chemistry, manufacturing and controls portions of a BLA for leronlimab as a combination therapy with antiretroviral therapy in treatment experienced HIV patients. FDA previously granted both a fast track designation for leronlimab and a rolling review for its BLA.

Leronlimab is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other disease, the company says. “Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients),” it says. Leronlimab masks CCR5 to protect healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.