Table 9.
Candidate | Sponsor | SOD | Format | Dose (mg) | ROA | MOA | Strategy | Clinical trial # | References |
---|---|---|---|---|---|---|---|---|---|
Evusheld™ | AstraZeneca | EUA | 2x IgGs mixture | 125 mg x two injections | IM | INJ | Px (long term) | NCT04625725 (ANR) | [497] |
REGEN-COV™ | Regeneron | EUA; Phase III | 2x IgGs mixture | 1200 mga | SC | INJ | Rx | NCT04452318 (C) | [498] |
CT-P63 and CT-P59 | Celltrion | Phase III | 2x IgGs mixture | ND | INH | NEB | Rx | NCT05224856 (NYR) | [499] |
Xevudy™ (UK); Sotrovimab (VIR-7831) |
Vir |
EUA; Phase II/III |
IgG | 250 mga, 500 mga | IM | INJ | Rx | NCT04913675 (ANR) | [209] |
AZD7442 | AstraZeneca | Phase III | 2x IgGs mixture | 300 mg a | IM | INJ | Rx | NCT04625972 (ANR) | [211] |
MAD0004108 | Toscana Life Sciences Sviluppo | Phase II/III | IgG | 100 mga, 400 mga | IM | INJ | Rx | NCT04952805 (R) | [221] |
ADG20 | Adagio | Phase II/III | IgG | 400 mga | IM | INJ | Px/Rx | NCT04859517 (R), NCT04805671 (R) | [219] |
BI 767551 (DZIF-10c) c |
Boehringer Ingelheim | Phase II/III | IgG | ND | INH | NEB | Rx | NCT04894474 (W) | [227] |
STI-2099 (COVI-DROPS) |
Sorrento | Phase II | IgG | 10-40 mga | IN | Drops | Rx | NCT04906694 (NYR), NCT04900428 (R) | [226] |
IGM-6268 (CoV-14) | IGM Biosciences | Phase I | IgM | 7.5 mg dose/day a | IN | Drops | Px/Rx |
NCT05160402 (R), NCT05184218 (R) |
[245, 246, 410] |
IgY-110 | Stanford | Phase I | IgY | 2-24 mga | IN | Drops | Rx | NCT04567810 (C) | [500] |
EU126-M2 | Eureka | PC | IgG | 1.25–10 mg/kgb | IN | Drops | Px | NA | [501, 502] |
Nb15-NbH-Nb15 | Abrev Biotech-nology Co., Ltd. | PC | Bispecific nanobody | 10 mg/kgb | IN | Drops | Px/Rx | NA | [503] |
PiN21 | University of Pittsburg | PC | Nanobody | 0.2 mg/kgb | IN | NEB | Px | NA | [253] |
1212C2 d | Aridis | PC | IgG | 0.6 mg/kgb | INH | NEB | Px/Rx | NA | [251] |
AUG-3387 | TFF Pharma-ceuticals/Augmenta Bioworks | PC | IgG | 0.3-1.0 mg/kgb | INH | Dry powder | Px/Rx | NA | [504] |
STI-9199 e (COVISHIELD™ IN) |
Sorrento Therapeutics, Inc/Mount Sinai | PC | Human IgG1-LALA | 0.5 mg/kgb | IN | Drops | Rx | NA | [254] |
ANR active not recruiting, C completed, EUA emergency use authorization granted, IM intramuscular, IN intranasal, INH inhalation, INJ injection, MOA mode of administration, NA not applicable, NCT National Clinical Trial (registry), ND not disclosed, NEB nebulizer, NYR not yet recruiting, PC preclinical, Px prophylaxis, R recruiting, ROA route of administration, Rx therapeutic treatment, SC subcutaneous, SOD stage of development, W withdrawn (from clinical development)
aClinical dose in mg (total)
bEfficacious preclinical dose in mg/kg
cDiscontinued from development 7/26/21
dPreclinical study was with antibody 1212C2, but plans are to move forward with AR-712, a cocktail consisting of two anti-SARS-CoV-2 IgGs [505]
eSTI-9199 is IN formulation of STI-9167, which has been shown to have strong neutralization activity against Omicron