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  • 1 Eötvös Loránd Tudományegyetem, Természettudományi Kar, , Budapest, Magyarország; Faculty of Science, Eötvös Loránd University, , Budapest, Hungary
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Összefoglaló. A SARS-CoV-2 koronavírus által kiváltott pandémia az elmúlt mintegy 100 év legsúlyosabb közegészségügyi, gazdasági és társadalmi válságát okozza. Az emberiség soha nem látott tudással, példa nélküli sebességgel állította elő azokat a hatékony védőoltásokat, amelyek a megfelelő átoltottság mellett kontrollálhatják a COVID–19-járványt.

A SARS-CoV-2 fertőzéssel az emberiségnek meg kell tanulnia együtt élni, és mivel a vakcinák nem mindenkinek adhatók, vagy nem mindenkiben váltanak ki immunvédelmet, szükséges a jelenleginél hatékonyabb COVID–19-specifikus terápiák kifejlesztése. Több COVID–19 kezelésére kifejlesztett gyógyszerhatóanyagot is sikerrel tesztelnek, közülük is kiemelkednek a monoklonális antitestek, illetve más biológiai terápiák. Ezek egyfelől olyan gyógyszerek, amelyek a betegség korai fázisában semlegesítik a vírust, azaz megakadályozzák, hogy a sejteket megfertőzze, míg mások a már kialakult súlyos megbetegedésben csökkenthetik a gyulladás mértékét. Biologikumok közé tartozik a SARS-CoV-2-t semlegesítő hACE2-Fc fúziós fehérje is, amely a neutralizáló monoklonális antitestek hatásához hasonlítható; előnye, hogy minden mutáns ellen hatékony lehet.

Virológusok, járványügyi szakemberek szerint fel kell készülnünk arra, hogy a jelenlegihez hasonló járványok rendszeressé válnak. Ökológiai okok miatt egyre nő az állati eredetű kórokozók adaptálódása az emberhez, de nem zárhatók ki az ún. laborszökevény vírusok, sőt a bioterrorizmus veszélye sem. Mindezek hatékony kezelésére erősítenünk kell a hazai biotechnológiai kapacitásokat. A hatóanyagfejlesztésben a már kialakult hazai egyetemi-kutatóintézeti-ipari együttműködésekre számíthatunk, a gyártás során pedig a hazai korszerű biotechnológiai, gyógyszeripari kapacitásra, amelyek növelhetik az önellátásból származó biztonságot.

Summary. The SARS-CoV-2 coronavirus pandemic is causing the worst public health, economic and social crisis in the last 100 years. New and effective vaccines were developed and produced with the application of unprecedented know how and speed, which can control the COVID-19 epidemic with the right vaccination coverage.

Humanity needs to learn to live with the SARS-CoV-2 infection, and because vaccines cannot be given to everyone or cannot induce immune protection in all vaccinated individuals, it is necessary to develop more effective COVID-19-specific therapies than those presently available. Several drugs developed for the treatment of COVID-19 have been successfully tested, including monoclonal antibodies and other biological therapies. These are, on the one hand, drugs that neutralize the virus in the early stages of the disease, that is, it prevents it from infecting the cells, while others can reduce the rate of inflammation in a severe disease status. This review article provides an update about the current status of monoclonal antibodies that have been developed to treat COVID-19.

In early 2020 Eotvos Lorand University, Pecs University, Gedeon Richter Plc and ImmunoGenes Ltd formed a consortium to develop a molecular trap, the human ACE2-Fc fusion protein that binds to the spike protein of SARS-CoV-2 and inhibits its binding to the ACE2 receptors on the cell surfaces. We successfully produced this recombinant protein and proved that it neutralizes this virus using VERO E6 cells and protects animals (Syrian hamster) from serious disease when administered before infection. We have also shown that it has a long half-life due to its (IgG) Fc-region component. Based on these proof of concept data, we created mutant versions of this drug candidate that do not have catabolic activity for angiotensin II and thus would not influence blood pressure. This is important since this drug should be administered in log-fold higher concentrations than ACE2 receptors in the body in order to efficiently neutralize the virus. The virus neutralization capacity of these new versions remained intact based on in vitro virus neutralization tests. We believe that after successful animal experiments, these drug candidates can be efficiently used in COVID-19 therapy in mild or moderate disease status. As compared to the COVID-19 specific monoclonal antibodies, we believe that these recombinant, mutant hACE2-Fc drugs can be more effective than the mAbs as they effectively bind and neutralize the new variants of SARS-CoV-2 (if they are able to bind the endogenous ACE2 receptor).

According to virologists and epidemiologists, we need to be prepared for epidemics like the current one becoming more regular. Due to ecological reasons, the adaptation of animal pathogens to humans is increasing, but there are threats due to lab leak viruses and even bioterrorism. To deal with all this effectively, we need to strengthen domestic biotechnology capacities. In the development of drug substances, we can count on the already established Hungarian university-research institute-industry collaborations, which can increase the safety resulting from self-sufficiency.

  • 1

    Chvatal-Medina, M., Mendez-Cortina, Y., Patiño, P. J., Velilla, P. A., & Rugeles, M. T. (2021) Antibody Responses in COVID-19: A Review. Front Immunol., 15 Apr 2021, .

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  • 2

    Dai, L., & Gao, G. F. (2021) Viral targets for vaccines against COVID-19. Nat Rev Immunol., Vol. 21. No. 2. pp. 73–82. .

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  • 3

    García, L. F. (2020) Immune Response, Inflammation, and the Clinical Spectrum of COVID-19. Front. Immunol., 16 June 2020, https://doi.org/10.3389/fimmu.2020.01441

  • 4

    Kruse, R. L. (2020) Therapeutic strategies in an outbreak scenario to treat the novel coronavirus originating in Wuhan, China. F1000Research 2020, 9:72, https://doi.org/10.12688/f1000research.22211.1

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    Torrente-López, A., Hermosilla, J., Navas, N., Cuadros-Rodríguez, L., Cabeza, J., & Salmerón-Gercía, A. (2021) The relevance of monoclonal antibodies in the treatment of COVID-19. Vaccine, Vol. 9. No. 6. 557. https://doi.org/10.3390/vaccines9060557

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    Wrapp, D., Wang, N., Corbett, S. K., Goldsmith, J. A., Hsieh, C.-L., Abiona, O., … McLellan, J. S. (2020) Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science, Vol. 367. No. 6483. pp. 1260-1263; .

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Ministry of Interior
Science Strategy and Coordination Department
Address: H-2090 Remeteszőlős, Nagykovácsi út 3.
Phone: (+36 26) 795 906
E-mail: scietsec@bm.gov.hu

2020  
CrossRef Documents 13
CrossRef Cites 0
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Days from submission to acceptance 247
Days from acceptance to publication 229
Acceptance Rate 36%

Publication Model Gold Open Access
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Scientia et Securitas
Language Hungarian
English
Size A4
Year of
Foundation
2020
Publication
Programme
2020 Volume 1
Volumes
per Year
1
Issues
per Year
4
Founder Academic Council of Home Affairs and
Association of Hungarian PhD and DLA Candidates
Founder's
Address
H-2090 Remeteszőlős, Hungary, Nagykovácsi út 3.
H-1055 Budapest, Hungary Falk Miksa utca 1.
Publisher Akadémiai Kiadó
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN ISSN 2732-2688

Editor-in-Chief:

  • Tamás NÉMETH 
    (Institute for Soil Sciences and Agricultural Chemistry, Centre for Agricultural Research
    Budapest, Hungary)

Managing Editor:

  • István SABJANICS (Ministry of Interior, Budapest, Hungary)

Editorial Board:

  • Melinda KOVÁCS (Szent István University Kaposvár Campus)Á
  • Miklós MARÓTH (Eötvös Loránd Research Network)
  • Charaf HASSAN (Budapest University of Technology and Economics)
  • Zoltán GYŐRI (Hungaricum Committee)
  • József HALLER (University of Public Service)
  • Attila ASZÓDI (Budapest University of Technology and Economics)
  • Zoltán BIRKNER (National Research, Development and Innovation Office)
  • Tamás DEZSŐ (Migration Research Institute)
  • Imre DOBÁK (University of Public Service)
  • András KOLTAY (University of Public Service)
  • Gábor KOVÁCS (University of Public Service)
  • József PALLO (University of Public Service)
  • Marcell Gyula GÁSPÁR (University of Miskolc)
  • Judit MÓGOR (Ministry of Interior National Directorate General for Disaster Management)
  • István SABJANICS (Ministry of Interior)
  • Péter SZABÓ (Hungarian University of Agriculture and Life Sciences (MATE))
  • Miklós SZÓCSKA (Semmelweis University)
  • János JÓZSA (Budapest University of Technology and Economics)
  • Valéria CSÉPE (Research Centre for Natural Sciences, Brain Imaging Centre)