Home
Post
Share
@CovidAnalysis
OutcomesOutcomes
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.
Pemivibart was adopted
in 1 country.
Submit updates/corrections .
Summary.
Jan 29 |
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofae631.2185 | Results from a Phase 1 First in Human Study of Pemivibart: An Extended Half-Life Monoclonal Antibody (mAb) |
| Phase 1 RCT with 30 healthy participants showing pemivibart was well-tolerated at doses up to 4500 mg, with no serious adverse events or adverse events leading to drug discontinuation reported. Pemivibart demonstrated linear and dose-prop.. | ||
Jan 29 |
et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofae631.2191 | Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) Titers Following the 2nd dose of Pemivibart in the Phase 3 CANOPY Trial |
| Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) analysis for the CANOPY trial showing a second dose boosted serum virus neutralizing antibody titers by 17% compared to the first dose. A population pharmacokinetic model .. | ||
Nov 14 2024 |
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 2024 |
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 2024 |
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 2024 |
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 2024 |
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 2024 |
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 2024 |
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 2024 |
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 2024 |
, 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 2024 |
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 2024 |
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.
Please send us corrections, updates, or comments.
c19early involves the extraction of 100,000+ datapoints from
thousands of papers. Community updates
help ensure high accuracy.
Treatments and other interventions are complementary.
All practical, effective, and safe
means should be used based on risk/benefit analysis.
No treatment or intervention is 100% available and effective for all current
and future variants.
We do not provide medical advice. Before taking any medication,
consult a qualified physician who can provide personalized advice and details
of risks and benefits based on your medical history and situation. FLCCC and WCH
provide treatment protocols.
Thanks for your feedback! Please search before submitting papers and note
that studies are listed under the date they were first available, which may be
the date of an earlier preprint.