TABLE 1 .
Known antibacterial monoclonal antibodies and related immunogic molecules that have entered clinical testing
| Bacterial species | Gram stain | Drug | Type | Target | Indication | Company | Phase | Status |
|---|---|---|---|---|---|---|---|---|
| Bacillus anthracis | Gram positive | Obiltoxaximab (Anthim, ETI-204) | Humanized IgG1 | Protective antigen (toxin) | Inhalational anthrax | Elusys | IV | FDA approved in 2016. In phase IV |
| Gram positive | Thravixa, AVP-21D9 | Human IgG1 | Protective antigen (toxin) | Inhalational anthrax | Emergent | I | Development suspended. Successful phase I trial in 2011 | |
| Gram positive | Valortim, MDX-1303 | Human IgG1 | Protective antigen (toxin) | Inhalational anthrax | PharmAthene | I | Development suspended. Successful phase I trial in 2011 | |
| Gram positive | Raxibacumab (Abthrax) | Human IgG1 | Protective antigen (toxin) | Inhalational anthrax | HGS/GSK | IV | FDA approved in 2012. Beginning phase IV | |
| Clostridium botulinum | Gram positive | XOMA 3ab | Mix of 3 humanized IgG1 | Botulinum neurotoxin type B (toxin) | Botulism | XOMA/NIAID | I | Development suspended. Successful phase I trial in 2013 |
| Gram positive | NTM-1632 | Mix of 3 humanized IgG1 | Botulinum neurotoxin type B (toxin) | Botulism | NIAID | I | In development. Completed phase I trial in 2017 | |
| Clostridium difficile | Gram positive | Actoxumab (CDA-1, MDX-066, MK-3415) | Human IgG1 | C. difficile toxin A (toxin) | Colitis | Merck | III | Development discontinued. Failed to show additional efficacy with bezlotoxumab in phase III trial in 2015 |
| Gram positive | Bezlotoxumab (Zinplava, CDB-1, MDX-1388, MK-6072) | Human IgG1 | C. difficile toxin B (toxin) | Colitis | Merck | III | FDA approved in 2016. In phase III for pediatric use | |
| Escherichia coli | Gram negative | Edobacumab (XOMEN-E5) | Mouse IgM | LPS lipid A (exopolysaccharide/endotoxin) | Sepsis | XOMA | III | Development discontinued. Successful phase III trial in 1991. FDA approval withheld and failed in later studies |
| Gram negative | Nebacumab (centoxin, HA-1A) | Human IgM | LPS lipid A (exopolysaccharide/endotoxin) | Sepsis | Centocor | III | Development discontinued. Successful phase III trial in 1991, failed in later studies | |
| Gram negative | T88 | Human IgM | LPS lipid A (exopolysaccharide/endotoxin) | Sepsis | Chiron | III | Development discontinued. Failed phase III trial in 1995 | |
| STECa | Gram negative | Shiga toxin MAbs, cαStx1 and -2 | Mix of 2 humanized IgG1 | E. coli Stx1 and Stx2 (toxins) | Bloody diarrhea in children | Taro (Thallion) | II | In development. Successful phase I trial in 2013 |
| Pseudomonas aeruginosa | Gram negative | Aerucin | Human IgG1 | P. aeruginosa alginate (exopolysaccharide) | Pneumonia | Aridis | II | In development. Open clinical trial |
| Gram negative | Panobacumab (Aerumab, AR-101, KBPA-101) | Human IgM | P. aeruginosa LPS O11 (exopolysaccharide) | Pneumonia | Aridis (Kenta) | II | In development. Successful phase IIa trial in 2009 | |
| Gram negative | KB001 | Human PEGylated Fab | P. aeruginosa PcrV (secretion system) | Chronic infection in CF patientsb | KaloBios | II | Development discontinued. Failed phase II trial in 2015 | |
| Gram negative | MEDI3902 | Bispecific human IgG1 | P. aeruginosa PcrV (secretion system) and Psl (exopolysaccharide) | Ventilator pneumonia prevention | MedImmune | II | In development. Open clinical trial | |
| Staphylococcus aureus | Gram positive | Salvecin, AR-301, KBSA-301 | Human IgG1 | S. aureus alpha-hemolysin (toxin) | Pneumonia | Aridis (Kenta) | II | In development. Completed phase II trial 2016 |
| Gram positive | ASN100 (ASN-1 and ASN-2 mix) | Mix of 2 human IgG1 | S. aureus alpha-hemolysin, HlgAB, HlgCB, LukED, LukSF, and LukGH (toxins) | Ventilator pneumonia prevention | Arsanis | II | In development. Open clinical trial | |
| Gram positive | Tefibazumab (Aurexis) | Humanized IgG1 | S. aureus ClfA (virulence protein) | Bacteremia, CF pneumonia | Bristol-Myers Squibb (Inhibitex) | II | Development discontinued. Failed phase II trial in 2006 | |
| Gram positive | MEDI4893 | Human IgG1 modified | S. aureus alpha-hemolysin (toxin) | Pneumonia | Astra Zeneca (MedImmune) | II | In development. Open clinical trial | |
| Gram positive | 514G3 | Human IgG3 | S. aureus protein A (virulence protein) | Bacteremia | Xbiotech | II | In development. Completed phase II trial in 2017 | |
| Gram positive | Pagibaximab (BSYX-A110) | Chimeric IgG1 | Lipoteichoic acid (exopolysaccharide) | Sepsis in low-birth-weight infants | Biosynexus | III | Development discontinued. Failed phase III trial in 2011 | |
| Gram positive | Aurograb | scFv | GrfA (lipoprotein) | Staphylococcal infection | NeuTec Pharma/Novartis | III | Development discontinued. Failed phase III trial in 2006 | |
| Multiple species | Gram positive and negative | F598 | Human IgG1 | Poly-N-acetylglucosamine (exopolysaccharide) | Multiple diseases | Alopexx | II | In development. Open clinical trial |
a
STEC, Shiga toxin-producing Escherichia coli.
b
CF, cystic fibrosis.