Ansuvimab

Specification

• Cat#: THA-0148
• Product Name: Ansuvimab
• Description: Ansuvimab is a fully human monoclonal IgG1 antibody directed against the GP1,2 surface protein of Zaire ebolavirus that is an effective treatment for Ebola virus disease.
• Introduction: Infection with pathogenic filoviruses, such as Zaire ebolavirus (Ebola virus, EBOV), can cause severe hemorrhagic fever in humans, resulting in frequent outbreaks with case fatality rates as high as 90%. Virtually all steps of the EBOV lifecycle have been targeted for therapeutic development. However, to date, the most successful method appears to be the development of monoclonal antibodies (mAbs) against the GP1,2 surface glycoprotein, as evidenced by the previously approved INMAZEB鈩?(REGN-EB3, a cocktail of atoltivimab, odesivimab, and maftivimab), the now approved ansuvimab, and ZMapp, which remains in clinical trials. Ansuvimab, formerly mAb114, is a fully human IgG1 mAb derived from a survivor of the 1995 Kikwit EBOV outbreak 11 years after infection, which displays strong glycan-independent binding to a conserved region of the GP1,2 protein that is responsible for interacting with the host NPC1 protein to mediate EBOV endolysosomal escape, a key step in the EBOV lifecycle. A randomized, controlled trial of four investigational therapies for Ebola virus disease (EVD) in the Democratic Republic of Congo during a previous outbreak that began in 2018 compared ansuvimab, REGN-EB3, ZMapp, and remdesivir, a nucleoside analogue designed to inhibit viral replication, showed ansuvimab and REGN-EB3 to be superior, with improved patient survival and faster viral clearance rates. Ansuvimab received FDA approval on December 21, 2020, and is currently marketed as Ebanga by Ridgeback Biotherapeutics, LP. Ansuvimab is just the second FDA-approved treatment for EVD.
• Purity: >99% by SDS-Page and HPLC analysis
• Appearance: Liquid
• Endotoxin Level: < 0.001 EU/μg of the protein by the LAL method

Pharmaceutical Information

• Pharmacodynamics: Ansuvimab is a human IgG1 monoclonal antibody directed against the Zaire ebolavirus GP1,2 surface glycoprotein that is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. The exposure-response relationship of ansuvimab is not currently understood, although the recommended treatment comprises only a single dose. Despite a good overall safety profile, ansuvimab treatment carries a risk of potentially life-threatening hypersensitivity reactions, including infusion-related reactions; in the case of hypersensitivity reactions, ansuvimab should be discontinued, and supportive care initiated immediately.
• Targets: Envelope glycoprotein