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Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection.
Lanini, Simone; Milleri, Stefano; Andreano, Emanuele; Nosari, Sarah; Paciello, Ida; Piccini, Giulia; Gentili, Alessandra; Phogat, Adhuna; Hyseni, Inesa; Leonardi, Margherita; Torelli, Alessandro; Montomoli, Emanuele; Paolini, Andrea; Frosini, Andrea; Antinori, Andrea; Nicastri, Emanuele; Girardi, Enrico; Plazzi, Maria Maddalena; Ippolito, Giuseppe; Vaia, Francesco; Della Cioppa, Giovanni; Rappuoli, Rino.
  • Lanini S; Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani - IRCCS, Rome, Italy.
  • Milleri S; Centro Ricerche Cliniche di Verona, University and Hospital Trust of Verona, Verona, Italy.
  • Andreano E; Monoclonal Antibody Discovery (MAD) Lab, Fondazione Toscana Life Sciences, Siena, Italy.
  • Nosari S; AchilleS Vaccine, Siena, Italy.
  • Paciello I; Monoclonal Antibody Discovery (MAD) Lab, Fondazione Toscana Life Sciences, Siena, Italy.
  • Piccini G; VisMederi S.r.l, Siena, Italy.
  • Gentili A; CROss Research, Mendrisio, Switzerland.
  • Phogat A; Fondazione Toscana Life Sciences, Siena, Italy.
  • Hyseni I; VisMederi S.r.l, Siena, Italy.
  • Leonardi M; VisMederi Research S.r.l, Siena, Italy.
  • Torelli A; VisMederi S.r.l, Siena, Italy.
  • Montomoli E; VisMederi Research S.r.l, Siena, Italy.
  • Paolini A; VisMederi S.r.l, Siena, Italy.
  • Frosini A; VisMederi S.r.l, Siena, Italy.
  • Antinori A; VisMederi Research S.r.l, Siena, Italy.
  • Nicastri E; Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.
  • Girardi E; Fondazione Toscana Life Sciences, Siena, Italy.
  • Plazzi MM; Toscana Life Sciences Sviluppo, Siena, Italy.
  • Ippolito G; Fondazione Toscana Life Sciences, Siena, Italy.
  • Vaia F; Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani - IRCCS, Rome, Italy.
  • Della Cioppa G; Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani - IRCCS, Rome, Italy.
  • Rappuoli R; Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani - IRCCS, Rome, Italy.
Nat Commun ; 13(1): 2263, 2022 04 27.
Article in English | MEDLINE | ID: covidwho-1815533
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / Antibodies, Monoclonal Type of study: Experimental Studies / Prognostic study Topics: Vaccines / Variants Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2022 Document Type: Article Affiliation country: S41467-022-29909-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / Antibodies, Monoclonal Type of study: Experimental Studies / Prognostic study Topics: Vaccines / Variants Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2022 Document Type: Article Affiliation country: S41467-022-29909-x