Odesivimab
Odesivimab Uses, Dosage, Side Effects, Food Interaction and all others data.
Ebola virus (EBOV) remains an important human pathogen within the Ebolavirus genus, having been responsible for at least 17 known outbreaks with an average case fatality rate of 43.92%. Immune therapy using monoclonal antibodies (mAbs) is becoming an increasingly attractive therapeutic method to combat infectious diseases due to its rapid development, low toxicity, and high specificity. The chief surface target of EBOV particles is the GP1,2 glycoprotein, which also appears on the surface of EBOV-infected cells, offering opportunities for both neutralizing and cytotoxic (i.e. through Fc-mediated immune effector function) antibody effects to play a role in combatting EBOV infection. A recent large-scale study elucidated that both neutralizing and Fc-mediated functions of antibodies were important for therapeutic benefit in animal models of EBOV infection.
INMAZEB™, formerly referred to as REGN-EB3, combines the three humanized IgG1κ mAbs Odesivimab (REGN 3471), Maftivimab (REGN 3479), and Atoltivimab (REGN 3470) in equimolar proportions. All three mAbs bind to a distinct portion of the GP1,2 glycoprotein and collectively provide neutralizing and Fc-mediated immune effector function against EBOV in vitro and protection against EBOV infection in vivo. INMAZEB™ is produced by Regeneron Pharmaceuticals and was granted FDA approval on October 14, 2020.
Odesivimab is a fully-humanized IgG1κ monoclonal antibody (mAb) directed against the GP1,2 glycoprotein that provides both neutralizing and Fc-dependent immune-mediated activity against Zaire ebolavirus. As a mAb, Odesivimab exhibits low toxicity and is generally well tolerated but does include the risk of potentially life-threatening hypersensitivity reactions.
| Trade Name | Odesivimab |
| Generic | Odesivimab |
| Odesivimab Other Names | Odesivimab, odesivimab-ebgn |
| Type | |
| Formula | C6506H10024N1720O2030S42 |
| Weight | 146164.54 Da (Polypeptide only) |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Odesivimab is part of a product containing three monoclonal IgG1κ antibodies directed against the GP<sub>1,2</sub> glycoprotein of Zaire ebolavirus. Together, these three antibodies act to neutralize viral particles and to recruit immune effectors for the destruction of both viral particles and infected cells.
Odesivimab is indicated in combination with Maftivimab and Atoltivimab for the treatment of Zaire ebolavirus infection in adult and pediatric patients, including neonates born to a mother who has been confirmed positive by RT-PCR for Zaire ebolavirus infection. This combination has not been established as efficacious for any other species within either the Ebolavirus or Marburgvirus genera; special care should be taken to evaluate the susceptibility of circulating Zaire ebolavirus strains before beginning treatment, and the possible emergence of resistance should be monitored.
Odesivimab is also used to associated treatment for these conditions: Ebola Virus Infection
How Odesivimab works
Ebola virus (EBOV) is one of several viruses within the Ebolavirus genus known to infect humans with an average case fatality rate of 43.92%. EBOV particles expose the GP1,2 glycoprotein on their surface, which comprises a trimer of GP1 and GP2 subunit heterodimers, with the subunits connected by a disulfide bond. GP1,2 plays an important role in both cell surface attachment/entry and eventual lysosomal escape through binding to the NPC intracellular cholesterol transporter 1/Niemann-Pick C1 protein (NPC1). In this manner, GP1,2 is integral to the pathogenic cycle of EBOV.
Odesivimab is a fully-humanized IgG1κ monoclonal antibody (mAb) directed against the EBOV GP1,2 glycoprotein, which binds within the "chalice" structure near the GP head in partial contact with the glycan cap with a binding affinity (KD) of between 8.26 and 8.42 nM. Odesivimab exhibits weak (1,2 and is able to bind soluble GP1,2. In addition, Odesivimab is capable of dose-dependent activation of FcγRIIIa signalling in effector cells in the presence of GP1,2-expressing cells with a half-maximal effective concentration (EC50) of 1.6 nM. Combined with Maftivimab and Atoltivimab, Odesivimab works to block EBOV cell infection and lysosomal escape, as well as the potential antibody-dependent cell-mediated killing of EBOV-infected cells.
Food Interaction
No interactions found.Volume of Distribution
Odesivimab administered to healthy subjects at 50 mg/kg produced a mean steady-state volume of distribution of 56.0 ± 3.16 mL/kg.
Elimination Route
Odesivimab administered to healthy subjects at 50 mg/kg produced a mean Cmax of 1260 ± 81.2 mg/L and a mean AUC0-∞ of 25,600 ± 5040 mg*day/L.
Half Life
Odesivimab administered to healthy subjects at 50 mg/kg has a mean elimination half-life of 25.3 ± 3.86 days.
Clearance
Odesivimab administered to healthy subjects at 50 mg/kg has a mean clearance of 2.02 ± 0.374 mL/day/kg.
Innovators Monograph
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