Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection

Simone Lanini, Stefano Milleri, Emanuele Andreano, Sarah Nosari, Ida Paciello, Giulia Piccini, Alessandra Gentili, Adhuna Phogat, Inesa Hyseni, Margherita Leonardi, Alessandro Torelli, Emanuele Montomoli, Andrea Paolini, Andrea Frosini, Andrea Antinori, Emanuele Nicastri, Enrico Girardi, Maria Maddalena Plazzi, Giuseppe Ippolito, Francesco Vaia, Giovanni Della Cioppa and Rino Rappuoli ()
Additional contact information
Simone Lanini: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Stefano Milleri: University and Hospital Trust of Verona
Emanuele Andreano: Fondazione Toscana Life Sciences
Sarah Nosari: AchilleS Vaccine
Ida Paciello: Fondazione Toscana Life Sciences
Giulia Piccini: VisMederi S.r.l
Alessandra Gentili: CROss Research
Adhuna Phogat: Fondazione Toscana Life Sciences
Inesa Hyseni: VisMederi S.r.l
Margherita Leonardi: VisMederi S.r.l
Alessandro Torelli: VisMederi S.r.l
Emanuele Montomoli: VisMederi S.r.l
Andrea Paolini: Fondazione Toscana Life Sciences
Andrea Frosini: Fondazione Toscana Life Sciences
Andrea Antinori: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Emanuele Nicastri: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Enrico Girardi: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Maria Maddalena Plazzi: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Giuseppe Ippolito: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Francesco Vaia: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani – IRCCS
Giovanni Della Cioppa: Clinical R&D Consultants
Rino Rappuoli: Fondazione Toscana Life Sciences

Nature Communications, 2022, vol. 13, issue 1, 1-8

Abstract: Abstract 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.

Date: 2022
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DOI: 10.1038/s41467-022-29909-x

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