Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline

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ABSTRACT

Monoclonal antibody (mAb) therapy has been previously exploited for viral infections, such as respiratory syncytial virus pneumonia and Ebolavirus disease. In the ongoing COVID-19 pandemic, early signals of efficacy from convalescent plasma therapy have encouraged research and development of anti-SARS-CoV-2 mAbs. While many candidates are in preclinical development, we focus here on anti-SARS-CoV-2 neutralizing mAbs (or mAb cocktails) that represent the late-stage clinical pipeline, i.e., those currently in Phase 2 or Phase 3 clinical trials. We describe the structure, mechanism of action, and ongoing trials for VIR-7831, LY-CoV555, LY-CoV016, BGB-DXP593, REGN-COV2, and CT-P59. We speculate also on the next generation of these mAbs.

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A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics

Sabue Mulangu, Lori Dodd, Richard Davey … (2019)

Although several experimental therapeutics for Ebola virus disease (EVD) have been developed, the safety and efficacy of the most promising therapies need to be assessed in the context of a randomized, controlled trial.

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The Effectiveness of Convalescent Plasma and Hyperimmune Immunoglobulin for the Treatment of Severe Acute Respiratory Infections of Viral Etiology: A Systematic Review and Exploratory Meta-analysis

John Mair-Jenkins, Maria Saavedra-Campos, J Baillie … (2014)

Background. Administration of convalescent plasma, serum, or hyperimmune immunoglobulin may be of clinical benefit for treatment of severe acute respiratory infections (SARIs) of viral etiology. We conducted a systematic review and exploratory meta-analysis to assess the overall evidence. Methods. Healthcare databases and sources of grey literature were searched in July 2013. All records were screened against the protocol eligibility criteria, using a 3-stage process. Data extraction and risk of bias assessments were undertaken. Results. We identified 32 studies of SARS coronavirus infection and severe influenza. Narrative analyses revealed consistent evidence for a reduction in mortality, especially when convalescent plasma is administered early after symptom onset. Exploratory post hoc meta-analysis showed a statistically significant reduction in the pooled odds of mortality following treatment, compared with placebo or no therapy (odds ratio, 0.25; 95% confidence interval, .14–.45; I2 = 0%). Studies were commonly of low or very low quality, lacked control groups, and at moderate or high risk of bias. Sources of clinical and methodological heterogeneity were identified. Conclusions. Convalescent plasma may reduce mortality and appears safe. This therapy should be studied within the context of a well-designed clinical trial or other formal evaluation, including for treatment of Middle East respiratory syndrome coronavirus CoV infection.

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Development of Clinical-Stage Human Monoclonal Antibodies That Treat Advanced Ebola Virus Disease in Nonhuman Primates

Kristen E Pascal, Drew Dudgeon, John Trefry … (2018)

Abstract Background For most classes of drugs, rapid development of therapeutics to treat emerging infections is challenged by the timelines needed to identify compounds with the desired efficacy, safety, and pharmacokinetic profiles. Fully human monoclonal antibodies (mAbs) provide an attractive method to overcome many of these hurdles to rapidly produce therapeutics for emerging diseases. Methods In this study, we deployed a platform to generate, test, and develop fully human antibodies to Zaire ebolavirus. We obtained specific anti-Ebola virus (EBOV) antibodies by immunizing VelocImmune mice that use human immunoglobulin variable regions in their humoral responses. Results Of the antibody clones isolated, 3 were selected as best at neutralizing EBOV and triggering FcγRIIIa. Binding studies and negative-stain electron microscopy revealed that the 3 selected antibodies bind to non-overlapping epitopes, including a potentially new protective epitope not targeted by other antibody-based treatments. When combined, a single dose of a cocktail of the 3 antibodies protected nonhuman primates (NHPs) from EBOV disease even after disease symptoms were apparent. Conclusions This antibody cocktail provides complementary mechanisms of actions, incorporates novel specificities, and demonstrates high-level postexposure protection from lethal EBOV disease in NHPs. It is now undergoing testing in normal healthy volunteers in preparation for potential use in future Ebola epidemics.

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Journal

Journal ID (nlm-ta): MAbs

Journal ID (iso-abbrev): MAbs

Title: mAbs

Publisher: Taylor & Francis

ISSN (Print): 1942-0862

ISSN (Electronic): 1942-0870

Publication date (Electronic, pub): 15 December 2020

Publication date Collection: Jan-Dec 2020

Publication date PMC-release: 15 December 2020

Volume: 12

Issue: 1

Electronic Location Identifier: 1854149

Affiliations

[a ]Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa; , Pisa, Italy

[b ]Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa; , Pisa, Italy

[c ]Division of Microbiology, Varese University Hospital; , Varese, Italy

[d ]Pisa University Hospital; , Pisa, Italy

Author notes

CONTACT Marco Tuccori marco.tuccori@ 123456gmail.com Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa; , 56126, Pisa.

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Emiliano Cappello https://orcid.org/0000-0003-0386-3816

Giulia Valdiserra https://orcid.org/0000-0003-1616-8644

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Publisher ID: 1854149

DOI: 10.1080/19420862.2020.1854149

PMC ID: 7755170

PubMed ID: 33319649

SO-VID: c418bbf8-6612-475f-97b2-28944c33b31d

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This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Most cited references 21

A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics

The Effectiveness of Convalescent Plasma and Hyperimmune Immunoglobulin for the Treatment of Severe Acute Respiratory Infections of Viral Etiology: A Systematic Review and Exploratory Meta-analysis

Development of Clinical-Stage Human Monoclonal Antibodies That Treat Advanced Ebola Virus Disease in Nonhuman Primates

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