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mAb use may create new variants that spread globally1,2, and may be associated with prolonged viral loads, clinical deterioration, and immune escape2-5.
Recent:Wang Powers Wolfe Schmidt Yao Bhimraj.
Pemivibart was adopted
in 1 country.
Submit updates/corrections .
Summary.
Nov 14 |
et al., New England Journal of Medicine, doi:10.1056/NEJMc2404555 | Immunobridging for Pemivibart, a Monoclonal Antibody for Prevention of Covid-19 |
| Discussion of immunobridging data for the monoclonal antibody pemivibart for prevention of COVID-19 in immunocompromised individuals. Pemivibart received Emergency Use Authorization from the FDA based on safety and immunobridging data fro.. | ||
Nov 14 |
et al., New England Journal of Medicine, doi:10.1056/NEJMc2410203 | Activity of Research-Grade Pemivibart against Recent SARS-CoV-2 JN.1 Sublineages |
| In Vitro study showing that a laboratory-synthesized version of the monoclonal antibody pemivibart had reduced neutralization activity against recent SARS-CoV-2 JN.1 sublineages. Pemivibart was authorized for COVID-19 pre-exposure prophyl.. | ||
Nov 13 |
et al., medRxiv, doi:10.1101/2024.11.11.24317127 | Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From the CANOPY Clinical Trial |
| 75% lower hospitalization (p=0.34), 74% lower progression (p<0.0001), and 76% fewer symptomatic cases (p<0.0001). Phase 3 trial of 306 immunocompromised adults and 484 non-immunocompromised adults showing pre-exposure prophylaxis with pemivibart was generally well-tolerated and provided protection against symptomatic COVID-19 through 6 months in.. | ||
Nov 13 |
et al., bioRxiv, doi:10.1101/2024.11.11.623127 | Neutralization of recent SARS-CoV-2 variants by genetically and structurally related mAbs of the pemivibart lineage |
| In Vitro study showing continued activity of pemivibart and 15 pemivibart-like monoclonal antibodies against recent SARS-CoV-2 variants KP.3, KP.3.1.1, and XEC. Authors found that all 15 antibodies maintained activity against KP.3.1.1, wi.. | ||
Nov 10 |
et al., bioRxiv, doi:10.1101/2024.11.08.622746 | Neutralizing Activity and Viral Escape of Pemivibart by SARS-CoV-2 JN.1 sublineages |
| In Vitro study showing that the monoclonal antibody pemivibart retains broad neutralizing activity against recent SARS-CoV-2 JN.1 sublineages but has reduced potency against KP.3.1.1 and XEC variants, with IC50 values ~22-fold higher than.. | ||
Oct 29 |
et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae435 | 2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Management of COVID-19: Anti-SARS-CoV-2 Neutralizing Antibody Pemivibart for Pre-exposure Prophylaxis |
| Update to IDSA clinical practice guidelines on the treatment and management of COVID-19, providing a conditional recommendation for pre-exposure prophylaxis with pemivibart, an anti-SARS-CoV-2 neutralizing antibody, in moderately or sever.. | ||
Sep 30 |
et al., Pathogens and Immunity, doi:10.20411/pai.v10i1.752 | Escape of SARS-CoV-2 Variants KP.1.1, LB.1, and KP.3.3 From Approved Monoclonal Antibodies |
| In Vitro study showing significant escape of SARS-CoV-2 variants KP.1.1, LB.1, and KP.3.3 with monoclonal antibodies pemivibart (VYD222) and sipavibart (AZD3152). Sipavibart lost antiviral efficacy, while pemivibart maintained reduced act.. | ||
Aug 13 |
et al., bioRxiv, doi:10.1101/2024.08.12.607496 | Pemivibart is less active against recent SARS-CoV-2 JN.1 sublineages |
| In Vitro study showing pemivibart has reduced neutralizing activity against recent SARS-CoV-2 JN.1 sublineages, particularly KP.3.1.1 which had a 32.7-fold higher IC50 compared to the original JN.1. Structural analyses suggest the Q493E m.. | ||
Aug 11 |
, D., Current Topics in Microbiology and Immunology, doi:10.1007/82_2024_268 | Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities |
| Review of monoclonal antibodies for SARS-CoV-2. Author notes that the omicron variant has reset achievements to date. | ||
Aug 8 |
et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae408 | Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship |
| Review arguing against use of single monoclonal antibodies for COVID-19 treatment, particularly in immunosuppressed patients, due to the risk of rapidly selecting for resistant viral variants. Authors suggest that while monoclonal antibod.. | ||
Mar 22 |
Press Release | Invivyd announces FDA authorization for emergency use of Pemgarda™ (formerly VYD222) for pre-exposure prophylaxis (PrEP) of COVID-19 |
| RCT 623 patients reporting immunobridging results from cohort A with 306 immunocompromised patients. Immunobridging estimates efficacy from the relationship between serum virus neutralizing antibody titers and clinical efficacy demonstrat.. | ||
Nov 27 2023 |
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofad500.1200 | Preliminary Safety Results from a Phase 1 First in Human Study of VYD222: an Extended Half-Life Monoclonal Antibody (mAb) in Development for COVID-19 Prevention |
| Phase 1 RCT of monoclonal antibody VYD222 (pemivibart) in 12 healthy adults, showing no serious adverse events or infusion-related reactions through 14 days with 1500mg and through 2 days with 2500mg. | ||
References
Focosi et al., Analysis of SARS-CoV-2 mutations associated with resistance to therapeutic monoclonal antibodies that emerge after treatment, Drug Resistance Updates, doi:10.1016/j.drup.2023.100991.
Leducq et al., Spike protein genetic evolution in patients at high-risk of severe COVID-19 treated by monoclonal antibodies, The Journal of Infectious Diseases, doi:10.1093/infdis/jiad523.
Choudhary et al., Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy, medRxiv, doi:10.1101/2021.09.03.21263105.
Günther et al., Variant-specific humoral immune response to SARS-CoV-2 escape mutants arising in clinically severe, prolonged infection, medRxiv, doi:10.1101/2024.01.06.24300890.
Casadevall et al., Single monoclonal antibodies should not be used for COVID-19 therapy: a call for antiviral stewardship, Clinical Infectious Diseases, doi:10.1093/cid/ciae408.
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