TMB-365 + TMB-380

TMB-365 + TMB-380 is a novel, long-acting combination of two broadly neutralizing monoclonal antibodies (bNAbs) developed as a complete regimen for front-line HIV maintenance therapy. The combination is designed to be administered as an intravenous infusion every eight weeks and targets people living with HIV who have achieved viral suppression. TMB-365 is a second-generation post-attachment bNAb that binds to the second domain of the CD4 receptor, while TMB-380 (also known as VRC07‑523LS) binds to the CD4 binding site on the HIV envelope protein. Both antibodies interfere with HIV entry into host cells through complementary mechanisms, providing broad coverage and high potency without requiring susceptibility screening prior to treatment. The regimen aims to reduce dosing frequency compared to daily oral antiretroviral therapy and has demonstrated robust efficacy and safety in Phase 2a clinical trials[1][3][5][8].