Cytodyn Inc (CYDY)

[Midasbro]

Great article.

https://www.frontiersin.org/articles/10.3389/fimmu.2021.816515/full

The drug Leronlimab is a humanized anti-CCR5 IgG4 monoclonal antibody that is delivered subcutaneously or intravenously (Table 1) (115). Preliminary studies have shown that contrary to natural antibodies, Leronlimab is able to bind the N-terminal domain of EL2 on the CCR5 receptor, the same binding site used by gp120 (Figure 2). This loop is thought to be a well conserved area of CCR5 encoding genes (108).

Studies in rhesus macaques showed dose-dependent protection from CCR5-utilizing infection following injections of Leronlimab subcutaneously. Additionally, 50 mg/kg prevented HIV-1 infection in all sites for all subjects, while just 10 mg/kg prevented infection in rectal tissue in all but one subject (117). In Phase 2 clinical trials in individuals with solely CCR5-utilizing HIV-1 intravenous Leronlimab infusion was well tolerated. Dosage as low as 5 mg/kg elicited maximum antiviral effects around 14 days post injection with greater than 1.8 log viral load reduction (118). In this same study, viral load rebounded to near baseline in all dosages around day 40 post-injection, highlighting a need for sustained treatment. No evidence of resistance or switched tropism was observed while only mild side effects were encountered with this medication, and it has been given a fast track status by the US Food and Drug Administration (FDA) (119).

Of the monoclonal antibodies directed at CCR5 that have been investigated, Leronlimab has achieved the most sustained receptor occupancy.