Preclinical assessment and randomized Phase I study of CT-P63, a broadly neutralizing antibody targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Seo, Ji-Min; Kang, Bobin; Song, Rina; Noh, Hanmi; Kim, Cheolmin; Kim, Jong-In; Kim, Min Soo; Ryu, Dong-Kyun; Lee, Min-Ho; Yang, Jeong‐Sun; Kim, Kyung-Chang; Lee, Joo-Yeon; Lee, Hansaem; Woo, Hye‐Min; Kim, Jun-Won; Choi, Jung-ah; Song, Manki; Tomaszewska-Kiecana, Monika; Wołowik, Anna; Kulesza, Agnieszka; Kim, SungHyun; Ahn, Keumyoung; Jung, Nahyun; Lee, Soo-Young

doi:10.1080/22221751.2022.2117094

Cited by 5 publications

(2 citation statements)

References 33 publications

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“…Several clinical trials have established the safety and some efficacy of mAb treatments [ 14 , 58 , 59 ], although optimal therapeutic efficacy generally requires early administration to COVID-19 patients [ 60 ]. Given the rapid and robust nature of the K18-hACE2 mouse model, antiviral activity of mAb treatment is often demonstrated in this model by administering the mAb prior to infection [ 48 , 49 , 50 , 52 ], although some mAb cocktails have shown significant anti-viral activity if given 24 h after infection [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

Monoclonal Antibodies Specific for SARS-CoV-2 Spike Protein Suitable for Multiple Applications for Current Variants of Concern

Morgan

Yan

et al. 2022

Viruses

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The global coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spawned an ongoing demand for new research reagents and interventions. Herein we describe a panel of monoclonal antibodies raised against SARS-CoV-2. One antibody showed excellent utility for immunohistochemistry, clearly staining infected cells in formalin-fixed and paraffin embedded lungs and brains of mice infected with the original and the omicron variants of SARS-CoV-2. We demonstrate the reactivity to multiple variants of concern using ELISAs and describe the use of the antibodies in indirect immunofluorescence assays, Western blots, and rapid antigen tests. Finally, we illustrate the ability of two antibodies to reduce significantly viral tissue titers in K18-hACE2 transgenic mice infected with the original and an omicron isolate of SARS-CoV-2.

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Section: Discussionmentioning

confidence: 99%

Monoclonal Antibodies Specific for SARS-CoV-2 Spike Protein Suitable for Multiple Applications for Current Variants of Concern

Morgan

Yan

et al. 2022

Viruses

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“…In the early phase of the pandemic, mAb treatment contributed to preventing a worsening of the disease and reducing hospitalisation and mortality rates [ 5 , 8 – 10 ]. In line with research on virus mutations, other antibodies were quickly developed to respond to virus mutations [ 8 , 11 ]. In particular, mAb treatment is used for early response to disease and is a vital option for some patients, including immunocompromised individuals, as it provides a prompt immune response [ 5 , 7 , 12 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea

Lee,

Bu,

Song

et al. 2023

Infect Dis Ther

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Introduction Regdanvimab, a neutralising monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), received approval for the treatment of coronavirus disease 2019 (COVID-19) in South Korea in 2021. The Ministry of Food and Drug Safety in South Korea mandate that new medications be re-examined for safety and effectiveness post-approval in at least 3000 individuals. This post-marketing surveillance (PMS) study was used to evaluate the safety and effectiveness of regdanvimab in real-world clinical care. Methods This prospective, multicentre, phase 4 PMS study was conducted between February 2021 and March 2022 in South Korea. Eligible patients were aged ≥ 18 years with confirmed mild COVID-19 at high risk of disease progression or moderate COVID-19. Patients were hospitalised and treated with regdanvimab (40 mg/kg, day 1) and then monitored until discharge, with a follow-up call on day 28. Adverse events (AEs) were documented, and the COVID-19 disease progression rate was used to measure effectiveness. Results Of the 3123 patients with COVID-19 infection identified, 3036 were eligible for inclusion. Approximately 80% and 5% of the eligible patients were diagnosed with COVID-19 during the delta- and omicron-dominant periods, respectively. Median (range) age was 57 (18–95) years, and 50.6% of patients were male. COVID-19 severity was assessed before treatment, and high-risk mild and moderate COVID-19 was diagnosed in 1030 (33.9%) and 2006 (66.1%) patients, respectively. AEs and adverse drug reactions (ADRs) were experienced by 684 (22.5%) and 363 (12.0%) patients, respectively. The most common ADR was increased liver function test ( n = 62, 2.0%). Nine (0.3%) patients discontinued regdanvimab due to ADRs. Overall, 378 (12.5%) patients experienced disease progression after regdanvimab infusion, with extended hospitalisation/re-admission ( n = 300, 9.9%) as the most common reason. Supplemental oxygen was required by 282 (9.3%) patients. Ten (0.3%) patients required intensive care monitoring and 3 (0.1%) died due to COVID-19. Conclusion This large-scale PMS study demonstrated that regdanvimab was effective against COVID-19 progression and had an acceptable safety profile when used in real-world clinical practice. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00859-1.

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Unraveling the structural and functional dimensions of SARS-CoV2 proteins in the context of COVID-19 pathogenesis and therapeutics

Jhanwar,

Sharma,

Das

2024

International Journal of Biological Macromolecules

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Preclinical assessment and randomized Phase I study of CT-P63, a broadly neutralizing antibody targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Cited by 5 publications

References 33 publications

Monoclonal Antibodies Specific for SARS-CoV-2 Spike Protein Suitable for Multiple Applications for Current Variants of Concern

Monoclonal Antibodies Specific for SARS-CoV-2 Spike Protein Suitable for Multiple Applications for Current Variants of Concern

Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea

Unraveling the structural and functional dimensions of SARS-CoV2 proteins in the context of COVID-19 pathogenesis and therapeutics

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