Table 2.
Selected mAbs marketed or in late-stage clinical studies for COVID-19
| Drug (brand name; company) | Origin | Engineering | Statusa | Omicron VOC neutralization | Ref. |
|---|---|---|---|---|---|
| Casirivimab and imdevimab (Ronapreve; Regeneron Pharmaceuticals) | Genetically humanized mice and B cells from a convalescent patient infected with SARS-CoV-2 | Unmodified | EUA granted by FDA for treatment and prevention of COVID-19 in 2020b | –, in vitro study322 | 118 |
| Bamlanivimab and etesevimab (NA; AbCellera/Eli Lilly) | B cells from convalescent patients infected with SARS-CoV-2 | Unmodified (bamlanivimab); LALA modification in Fc domain to extend half-life (etesevimab) | EUA granted by FDA for treatment and prevention of COVID-19 in 2021b | –, in vitro study322 | 124 |
| Sotrovimab (Xevudy; Vir Biotechnology/GlaxoSmithKline) | B cells from an individual infected with SARS-CoV | LS modification in Fc domain to extend half-life | EUA granted by FDA for the treatment of mild to moderate COVID-19 in 2021b | +/–, in vitro and clinical studies133,322–325 | 78 |
| Tixagevimab and cilgavimab (Evusheld; AstraZeneca) | B cells from convalescent patients infected with SARS-CoV-2 | YTE and TM modifications in Fc domain to extend half-life and reduce effector function, respectively | EUA granted by FDA for pre-exposure prophylaxis of COVID-19 in 2021 | +/–, in vitro study322 | 128 |
| Bebtelovimab (NA; AbCellera/Eli Lilly) | B cells from convalescent patients infected with SARS-CoV-2 | Unmodified | EUA granted by FDA for treatment of mild to moderate COVID-19 in 2022 | +++, in vitro study131 | 131 |
| Regdanvimab (Regkirona; Celltrion) | B cells from convalescent patient infected with SARS-CoV-2 | Modifications to Fc domain to reduce effector function | Approved in Republic of Korea and EU | –, in vitro study326 | 130 |
| Amubarvimab and romlusevimab (NA; Brii Biosciences) | B cells from convalescent patients infected with SARS-CoV-2 | YTE modification in Fc domain to extend half-life | Approved in China; EUA requested | +/–, in vitro and clinical studies323–325 | 327 |
| Adintrevimab (NA; Adagio Therapeutics) | B cells from convalescent patients infected with SARS-CoV-2 | LALA modification in Fc domain to extend half-life | Phase II/III | +/–, in vitro study323 | 328 |
All monoclonal antibodies (mAbs) listed are known to target the receptor-binding domain (RBD) of the spike (S) glycoprotein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Fc, crystallizable fragment; NA, not available; –, no neutralizing activity; +/–, partial neutralizing activity; +++, potent neutralizing activity. aInformation on status is with regard to the initial US Food and Drug Administration (FDA) emergency use authorizations (EUAs), unless the product was initially further advanced in other regions or countries. bEUA since withdrawn owing to likely ineffectiveness against the Omicron variant of concern (VOC).