Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection.
Simone LaniniStefano MilleriEmanuele AndreanoSarah NosariIda PacielloGiulia PicciniAlessandra GentiliAdhuna PhogatInesa HyseniMargherita LeonardiAlessandro TorelliEmanuele MontomoliAndrea PaoliniAndrea FrosiniAndrea AntinoriEmanuele NicastriEnrico GirardiMaria Maddalena PlazziGiuseppe IppolitoFrancesco VaiaGiovanni Della CioppaRino RappuoliPublished in: Nature communications (2022)
The emerging threat represented by SARS-CoV-2 variants, demands the development of therapies for better clinical management of COVID-19. MAD0004J08 is a potent Fc-engineered monoclonal antibody (mAb) able to neutralize in vitro all current SARS-CoV-2 variants of concern (VoCs) including the omicron variant even if with significantly reduced potency. Here we evaluated data obtained from the first 30 days of a phase 1 clinical study (EudraCT N.: 2020-005469-15 and ClinicalTrials.gov Identifier: NCT04932850). The primary endpoint evaluated the percentage of severe adverse events. Secondary endpoints evaluated pharmacokinetic and serum neutralization titers. A single dose administration of MAD0004J08 via intramuscular (i.m.) route is safe and well tolerated, resulting in rapid serum distribution and sera neutralizing titers higher than COVID-19 convalescent and vaccinated subjects. A single dose administration of MAD0004J08 is also sufficient to effectively neutralize major SARS-CoV-2 variants of concern (alpha, beta, gamma and delta). MAD0004J08 can be a major advancement in the prophylaxis and clinical management of COVID-19.