cilgavimab

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cilgavimab

GtoPdb Ligand ID: 11329

Synonyms: AZD1061 | COV2-2130 | Evusheld® (tixagevimab + cilgavimab)

cilgavimab is an approved drug (EMA (2022))

Comment: Cilgavimab is a monoclonal antibody against the surface spike protein of SARS-CoV-2 [3]. It was developed by AstraZeneca. This mAb blocks spike binding to ACE2 and prevents infection in animals. It is designed to be a long-acting agent, and in combination with tixagevimab (co-packaged combination= Evusheld®), is proposed as a therapeutic for those people who are likely to respond poorly to SARS-CoV-2 vaccines, or who cannot be vaccinated for any reason, including those who are immunocompromised [1]. Data from the Phase 3 PROVENT trial (NCT04625725) show protection from infection that lasts for at least six months. AstraZeneca have reported that Evusheld® retains neutralising activity against the BA.1 omicron (B.1.1.529) SARS-CoV-2 variant. Cilgavimab as a single agent rmore effectively neutralises the BA.2 omicron subvariant than tixagevimab in vitro [2], so the combination retains neutralising activity.

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Summary of Clinical Use
In clinical evaluation for COVID-19 as cocktail AZD7442 (trade named Evusheld®), which contains tixagevimab (AZD8895) + cilgavimab (AZD1061). These two mAbs have non-overlapping epitopes on the SARS-CoV-2 spike protein [1]. AZD7442 is being evaluated for efficacy as pre- and post-exposure prophylaxis of COVID-19. Evusheld® was granted FDA EUA for pre-exposure prophylaxis of COVID-19 in late 2021. However as the pattern of globally circulating variants evolved in mid-late 2022, Evusheld's efficacy was severly compromised, and in January 2023 the FDA withdrew the EUA.

Summary of Clinical Use

In clinical evaluation for COVID-19 as cocktail AZD7442 (trade named Evusheld®), which contains tixagevimab (AZD8895) + cilgavimab (AZD1061). These two mAbs have non-overlapping epitopes on the SARS-CoV-2 spike protein [1]. AZD7442 is being evaluated for efficacy as pre- and post-exposure prophylaxis of COVID-19. Evusheld® was granted FDA EUA for pre-exposure prophylaxis of COVID-19 in late 2021. However as the pattern of globally circulating variants evolved in mid-late 2022, Evusheld's efficacy was severly compromised, and in January 2023 the FDA withdrew the EUA.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT04507256	AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19	Phase 1 Interventional	AstraZeneca
NCT04625972	Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults	Phase 3 Interventional	AstraZeneca	AstraZeneca have announced that AZD7442 failed to improve outcomes when administered shortly after exposure to SARS-CoV-2.
NCT04625725	Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.	Phase 3 Interventional	AstraZeneca	The PROVENT study: In August 2021 AstraZeneca announced that AZD7442 met its primary endpoint in this study, reducing the risk of developing symptomatic COVID-19 by 77% [...]. There were no cases of severe COVID-19 or COVID-19-related deaths in the AZD7442 treatment arm; 2 of 3 people in the placebo group who contracted COVID-19 died, the third developed severe disease. Protection from infection is said to last for at least six months.

External links
For extended ADME data see the following: Drugs.com

External links

For extended ADME data see the following:

Drugs.com