Table 1.
Approved and most advanced mAbs in clinical development targeting infectious disease.
Target | mAb (brand name) | Company | Format | Technology | Indication& | Stage |
---|---|---|---|---|---|---|
Respiratory syncytial virus (RSV) Fusion glycoprotein | Palivizumab (Synagis) | MedImmune / AbbVie Inc. | Humanized IgG1 | Hybridoma | Prevention of RSV infection | US Approval 1998 |
Bacillus anthracis Protective Antigen (PA) | Raxibacumab (Abthrax) | GlaxoSmithKline / Human Genome Sciences (HGSI) | Human IgG1 | Transgenic mice | Anthrax infection | US Approval 2012 |
Bacillus anthracis Protective Antigen (PA) | Obiltoxaximab (Anthim) | Elusys Therapeutics | Chimeric IgG1 | Hybridoma | Prevention of inhalational anthrax | US Approval 2016 |
Clostridium difficile enterotoxin B | Bezlotoxumab (Zinplava) | Merck | Human IgG1 | Transgenic mice | Prevention of Clostridium difficile infection recurrence | US Approval 2016 |
Rabies Virus glycoprotein G | SII Rmab (Rabishield) | Serum Institute of India / MassBiologics | Human IgG1 | Transgenic mice | Rabies Post-exposure prophylaxis | India Approval 2016 |
CD4 | Ibalizumab (Trogazo) | Taimed Biologics / Theratechnologies | Humanized IgG4 | Hybridoma | Drug-resistant HIV-1 | US Approval 2018 |
Rabies Virus glycoprotein G | RabiMabs, M777−16-3 / MAb 62−71-3 Mab5 (Twinrab) | Zydus Cadila | Mixture of murine IgG1 (M777−16-3) and IgG2b (62−71-3) | Hybridoma | Rabies post-exposure prophylaxis | India Approval 2019 |
Zaire Ebola virus (EBOV) glycoprotein | Ansuvimab / mAb114 | Ridgeback Biotherpeutics / Vir Biotechnology / Humabs Biomed | Human IgG1 | Human donor | Ebola virus infection | Under FDA approval (2020) |
Zaire Ebola virus (EBOV) glycoprotein | REGN-EB3 | Regeneron Pharmaceuticals | Mixture of 3 human IgG1 (REGN3470, 3471, and 3479) | Transgenic mice | Ebola virus infection | Under FDA approval (2020) |
Staphylococcus aureus Hla | Tosatoxumab / AR-301 (Salvecin) | Aridis Pharmaceuticals / Kenta Biotech | Human IgG1 | Human donor | Treatment of ventilator- and hospital-associated pneumonia | Ph III (NCT03816956) |
SARS-CoV-2 Spike protein | REGN10933 and REGN10987 combination therapy | Regeneron Pharmaceuticals | Human IgG1 | Transgenic mice | COVID-19 | Ph III (NCT04426695) |
SARS-CoV-2 Spike protein | Ly-CoV555 | Eli Lilly | Human IgG1 | Human donor | COVID-19 | Ph III (NCT04497987) |
CCR-5 | Leronlimab / PRO 140 / PA-14 | CytoDyn / Progenics Pharmaceuticals | Humanized IgG4 | Hybridoma | HIV-1 infection | Ph III (NCT03902522) |
CD4 | UB-421 / dB4 / dB4C7 | United BioPharma | Humanized IgG1 | Hybridoma | HIV-1 infection | Ph III (NCT03149211) |
Rabies virus glycoprotein | NM-57 / SO-57 / SOJB | North China Pharmaceutical | Rabies Post-exposure prophylaxis | Ph III | ||
Respiratory syncytial virus (RSV) Fusion glycoprotein | Nirsevimab / MEDI-8897 | Sanofi & AstraZeneca / MedImmune | Human IgG1, half-life extended | Human donor | Prevention of RSV infection | Ph II-III (NCT03959488) |
Heptatitis B virus HBsAg | Lenvervimab / GC-1102 | GC Pharma | Humanized IgG1 | Phage display library from HBV vaccinees | Prevention and treatment of hepatitis-B virus (HBV) | Ph II-III (NCT03801798) |
SARS-CoV-2 Spike protein | VIR-7831 (GSK4182136) | Vir Biotechnology / GlaxoSmithKline | Half-life extended human mAb | Human donor | COVID-19 | Ph II-III (NCT04545060) |
Ebola virus (EBOV) glycoprotein | Larcaviximab / ZMapp | Mapp Biopharmaceutical | Chimeric IgG1 | Hybridoma | Ebola infection | Ph II-III (NCT03719586) |
HIV-1 Envelope protein CD4 binding site (CD4bs) | VRC-HIVMAB060−00-AB / VCR01 | NIAID | Human IgG1 | Human donor | Prevention of HIV-1 infection | Ph II (NCT02716675) |