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Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV-2 Omicron variant (B.1.1.529) in K18-hACE2 mice

Lee Tatham, Joanne Sharp, Edyta Kijak, Joanne Herriott, Megan Neary, Helen Box, Anthony Valentijn, Helen Cox, Henry Pertinez, Paul Curley, Usman Arshad, Rajith KR Rajoli, Steve Rannard, James Stewart, View ORCID ProfileAndrew Owen
doi: https://doi.org/10.1101/2022.01.23.477397
Lee Tatham
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Joanne Sharp
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Edyta Kijak
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Joanne Herriott
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Megan Neary
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Helen Box
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Anthony Valentijn
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Helen Cox
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Henry Pertinez
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Paul Curley
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Usman Arshad
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Rajith KR Rajoli
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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Steve Rannard
2Department of Chemistry, University of Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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James Stewart
3Department of Infection Biology & Microbiomes, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, UK
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Andrew Owen
1Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, L7 3NY, UK
4Centre of Excellence in Long-acting Therapeutics (CELT), University of Liverpool, Liverpool, L7 3NY, UK
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  • ORCID record for Andrew Owen
  • For correspondence: aowen@liverpool.ac.uk
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Abstract

The Omicron variant (B.1.1.529) of SARS-CoV-2 has placed enormous strain on global healthcare systems since it was first identified by South African researchers in late 2021. Omicron has >50 mutations which mainly occur in the surface spike protein and this has led to rapid assessment of monoclonal antibodies to assess the impact on virus neutralisation. Ronapreve has shown potential application in post-exposure prophylaxis, mild/moderate disease and in seronegative patients with severe COVID19, but several early reports of loss of in vitro neutralisation activity have been documented. Here, the virological efficacy of Ronapreve was assessed in K18-hACE2 mice to provide an in vivo outcome. Ronapreve reduced sub-genomic RNA in lung and nasal turbinate for the Delta variant but not the Omicron variant of SARS-CoV-2 at doses 2-fold higher than those shown to be active against previous variants of the virus. These data add to the growing evidence that the effectiveness of Ronapreve is compromised for the Omicron variant.

Competing Interest Statement

AO and SR are Directors of Tandem Nano Ltd and co-inventors of patents relating to drug delivery. AO has received research funding from ViiV, Merck, Janssen and consultancy from Gilead, ViiV and Merck not related to the current paper. SR has received research funding from ViiV and AstraZeneca and consultancy from Gilead not related to the current paper. No other conflicts are declared by the authors.

Footnotes

  • Conflicts of interest statement AO and SR are Directors of Tandem Nano Ltd and co-inventors of patents relating to drug delivery. AO has received research funding from ViiV, Merck, Janssen and consultancy from Gilead, ViiV and Merck not related to the current paper. SR has received research funding from ViiV and AstraZeneca and consultancy from Gilead not related to the current paper. No other conflicts are declared by the authors.

  • Funding AO acknowledges funding by Unitaid as a COVID-19 supplement to project LONGEVITY, Wellcome Trust (222489/Z/21/Z), EPSRC (EP/R024804/1; EP/S012265/1), and NIH (R01AI134091; R24AI118397). JPS acknowledges funding from MRC (MR/W005611/1, MR/R010145/1), BBSRC (BB/R00904X/1; BB/R018863/1; BB/N022505/1) and Innovate UK (TS/V012967/1).

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted January 24, 2022.
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Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV-2 Omicron variant (B.1.1.529) in K18-hACE2 mice
Lee Tatham, Joanne Sharp, Edyta Kijak, Joanne Herriott, Megan Neary, Helen Box, Anthony Valentijn, Helen Cox, Henry Pertinez, Paul Curley, Usman Arshad, Rajith KR Rajoli, Steve Rannard, James Stewart, Andrew Owen
bioRxiv 2022.01.23.477397; doi: https://doi.org/10.1101/2022.01.23.477397
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Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV-2 Omicron variant (B.1.1.529) in K18-hACE2 mice
Lee Tatham, Joanne Sharp, Edyta Kijak, Joanne Herriott, Megan Neary, Helen Box, Anthony Valentijn, Helen Cox, Henry Pertinez, Paul Curley, Usman Arshad, Rajith KR Rajoli, Steve Rannard, James Stewart, Andrew Owen
bioRxiv 2022.01.23.477397; doi: https://doi.org/10.1101/2022.01.23.477397

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