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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

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Front. Med.    2023, Vol. 17 Issue (6) : 1117-1134    https://doi.org/10.1007/s11684-023-1021-y
Passive antibody therapy in emerging infectious diseases
Xiaoming Yang()
National Engineering Technology Research Center for Combined Vaccines, Wuhan 430207, China; Wuhan Institute of Biological Products Co., Ltd., Wuhan 430207, China; China National Biotec Group Company Limited, Beijing 100029, China
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Abstract

The epidemic of corona virus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 and its variants of concern (VOCs) has been ongoing for over 3 years. Antibody therapies encompassing convalescent plasma, hyperimmunoglobulin, and neutralizing monoclonal antibodies (mAbs) applied in passive immunotherapy have yielded positive outcomes and played a crucial role in the early COVID-19 treatment. In this review, the development path, action mechanism, clinical research results, challenges, and safety profile associated with the use of COVID-19 convalescent plasma, hyperimmunoglobulin, and mAbs were summarized. In addition, the prospects of applying antibody therapy against VOCs was assessed, offering insights into the coping strategies for facing new infectious disease outbreaks.
Keywords SARS-CoV-2      COVID-19      convalescent plasma      hyperimmunoglobulin      neutralizing monoclonal antibodies     
Corresponding Author(s): Xiaoming Yang   
Just Accepted Date: 13 October 2023   Online First Date: 29 November 2023    Issue Date: 06 February 2024
 Cite this article:   
Xiaoming Yang. Passive antibody therapy in emerging infectious diseases[J]. Front. Med., 2023, 17(6): 1117-1134.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-023-1021-y
https://academic.hep.com.cn/fmd/EN/Y2023/V17/I6/1117
Fig.1  Different neutralizing mAbs target different sites of S protein. Most of the approved COVID-19 monoclonal antibodies target S1 receptor-binding domain (RBD), other target site including: S1 N-terminal domain (NTD), S2 fusion peptide, S2 stem helix (SH).
Fig.2  Schematics of obtaining and industrial production of CCP, COVID-HIG, and mAbs. Blood is collected from a patient who recovered from COVID-19. (A) For CCP preparation, plasma cells are first obtained by centrifugation, and viruses in serum are removed or inactivated. Then, the SARS-CoV-2-specific antibody is detected. Qualified samples can be used for CCP therapy. (B) For COVID-HIG preparation, blood is centrifuged to collect the supernatant plasma, and plasmas from different individuals are mixed, inactivated, separated, and purified. Antibody testing is performed, and qualified samples can be used for COVID-HIG therapy. (C) mAbs are prepared by single B cell sorting technology. First, peripheral blood mononuclear cells (PBMCs) are isolated from the whole blood. Then, target B cells are screened from PBMCs by using flow cytometry. The gene sequence of the SARS-CoV-2 specific antibody secreted from target B cells is analyzed. Plasmid expression of SARS-CoV-2-specific antibody is conducted, and a stable cell line is generated by incorporating the transfection plasmid into the host CHO cell genome. The CHO cells are inoculated with stepwise amplification, and the culture supernatant is clarified by filtration, purified through chromatography, and concentrated through ultrafiltration. After the virus is removed, the mAb formulation is obtained for COVID-19 treatment.
Antibody nameTarget siteCompanySuitable for the crowd/ClinicalTrials.gov IdentifierRelevant progress
BamlanivimabmAbs to RBDEli Lilly and CompanyIndividuals aged 12 years or older weighing at least 40 kg, mild-to-moderate COVID-19Granted EUA by the FDA in November 2020/withdrawn [82]
Casirivimab/imdevimabmAbs to RBDRegeneron Pharmaceuticals/RocheIndividuals aged ≥ 12 years and older who have recently tested positive for coronavirus, mild-to-moderate COVID-19Granted EUA by the FDA in November 2020/withdrawn; approved for marketing in Japan, UK, EU, and Australia [83]
Bamlanivimab/etesevimabmAbs to different epitopes of RBDEli Lilly/Junshi BiosciencesIndividuals aged ≥ 12 and older weighing at least 40 kg, mild-to-moderate COVID-19Granted EUA by the FDA in February 2021/withdrawn [84]
SotrovimabmAbs to RBDGSK/Vir BiotechnologyIndividuals aged ≥ 12 years and older who have recently tested positive for coronavirus, mild-to-moderate COVID-19Granted EUA by the FDA in May 2021/withdrawn [85]
Tixagevimab/cilgavimabIgG1 mAbs to RBDAstraZenecaIndividuals aged ≥ 12 years and older who have recently tested positive for coronavirus, mild-to-moderate COVID-19Granted EUA by the FDA in December 2021/withdrawn; approved for marketing in EU in March 2022 [86]
BebtelovimabIgG1 mAbs to RBDEli LillyIndividuals aged 12 years or older weighing at least 40 kg, mild-to-moderate COVID-19Granted EUA by FDA in February 2022/withdrawn [87]
Amubarvimab/romlusevimabmAb to RBDBrii BiosciencesMild COVID-19 in patients aged ≥ 18 years, and those aged 12–17 years with a body weight of ≥ 40 kg (conditional approval) who are at high risk of progressing to severe diseaseApproved for marketing in China in December 2021/withdrawn [77]
RegdanvimabmAb to RBDCelltrionIndividuals aged > 50 years with at least one underlying medical condition (obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients on immunosuppressive agents) and mild symptoms of COVID-19 and in adult patients with moderate symptoms of COVID-19Approved for marketing in Korea and EU/withdrawn [88]
TY027mAb to SARS-COV-2Tychan Pte. Ltd.NCT04649515Phase III clinical trial/active
ADM038201:1 mixture of two human IgG1 targeting different epitopes of RBDOlogy BioservicesNCT05142527Phase II/III clinical trial/withdrawn
ADG20mAb to RBDAdagio TherapeuticsNCT04805671Phase II/III clinical trial/terminated
SCTA01mAb to S proteinSinoCellTechNCT04683328/ NCT04709328Phase II/III clinical trial/unknown
MAD0004J08IgG1 mAbs to S proteinToscana Life Sciences Sviluppo s.r.l.NCT04952805Phase II/III clinical trial/active, not recruiting
LenzilumabAntihuman GM-CSF mAbHumanigen, Inc.NCT04351152Phase III clinical trial/unknown
BevacizumabAnti-VEGF humanized mAbQilu Hospital of Shandong UniversityNCT04305106Phase III clinical trial/recruiting
LeronlimabIgG4, kappa mAb that recognizes CCR5Hospital Israelita Albert EinsteinNCT04901676/ NCT04901689Phase III clinical trial/suspended
RavulizumabmAbs targeting terminal complement productsBrigham and Women’s HospitalNCT04570397Phase III clinical trial/active, not recruiting
MeplazumabAnti-CD147 IgG2 mAbJiangsu Pacific Meinuoke Bio Pharmaceutical Co., Ltd.NCT05679479Phase III clinical trial/recruiting
TocilizumabIgG1 mAbs to human IL-6 receptorAsociacion Instituto BiodonostiaNCT05002517Phase III clinical trial/active, not recruiting
LY3819253mAb to RBDNIAIDNCT05780268Phase III/completed
VIR-7831IgG1 kappa mAbNIAIDNCT05780281Phase III/completed
AZD8895 and AZD1061IgG1 kappa mAbNIAIDNCT05780437Phase III/completed
BRII-196IgG1 mAbNIAIDNCT05780424Phase III/completed
MavrilimumabGM-CSF-Rα mAbKiniksa Pharmaceuticals, Ltd.NCT04447469Phase III/completed
SarilumabIgG1 mAbAssistance Publique-H?pitaux de ParisNCT04324073Phase III clinical trial/unknown
Tab.1  Research progress of mAbs
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