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

Author

Listed:
  • 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
    VisMederi Research S.r.l)

  • Margherita Leonardi

    (VisMederi S.r.l
    VisMederi Research S.r.l)

  • Alessandro Torelli

    (VisMederi S.r.l)

  • Emanuele Montomoli

    (VisMederi S.r.l
    VisMederi Research S.r.l
    University of Siena)

  • Andrea Paolini

    (Fondazione Toscana Life Sciences
    Toscana Life Sciences Sviluppo)

  • 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
    University of Siena)

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.

Suggested Citation

  • Simone Lanini & Stefano Milleri & Emanuele Andreano & Sarah Nosari & Ida Paciello & Giulia Piccini & Alessandra Gentili & Adhuna Phogat & Inesa Hyseni & Margherita Leonardi & Alessandro Torelli & Eman, 2022. "Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection," Nature Communications, Nature, vol. 13(1), pages 1-8, December.
    • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-29909-x
    DOI: 10.1038/s41467-022-29909-x
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