Topic
Inmazeb
A monoclonal-antibody treatment approved for Zaire ebolavirus infection.
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Background
Selected excerpts from Wikipedia. This is general background, not Angle's reporting, and it may have changed since the stories above were published.
Atoltivimab/maftivimab/odesivimab, sold under the brand name INMAZEB, is a fixed-dose combination of three monoclonal antibodies for the treatment of ebola caused by Zaire ebolavirus. It was developed by Regeneron Pharmaceuticals and contains three human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab-ebgn.
The most common side effects include fever, chills, tachycardia (fast heart rate), tachypnea (fast breathing), and vomiting; however, these are also common symptoms of Ebola virus infection.
Atoltivimab/maftivimab/odesivimab is the first FDA-approved treatment for Zaire ebolavirus. Atoltivimab/maftivimab/odesivimab was approved for medical use in the United States in October 2020. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. It is on the World Health Organization's List of Essential Medicines.
Contraindications
People who receive atoltivimab/maftivimab/odesivimab should avoid the concurrent administration of a live vaccine due to the treatment's potential to inhibit replication of a live vaccine virus indicated for prevention of Ebola virus infection and possibly reduce the vaccine's efficacy.
Pharmacology
Atoltivimab/maftivimab/odesivimab is a combination of Zaire ebolavirus glycoprotein-directed human monoclonal antibodies. The three antibodies target the glycoprotein that is on the surface of the Ebola virus. This glycoprotein normally attaches to the cell via a receptor and fuses the viral and host cell membranes allowing the virus to enter the cell. The antibodies can bind to it simultaneously at three different locations and block attachment and entry of the virus.
This combination drug targets the Zaire species of Ebola virus. The Sudan and Bundibugyo strains have also caused outbreaks, and it is unlikely that it would be effective against these strains.
History
The 2014 Ebola outbreak killed more than 11,300 people. In the Democratic Republic of Congo (DRC), as of January 2020, this is the second largest outbreak with over 3,400 confirmed or probable cases, including more than 2,200 deaths.
Regeneron used its VelociGene, VelocImmune, and VelociMab antibody discovery and production technologies and coordinated with the U.S. government's Biomedical Advanced Research and Development Authority (BARDA). The therapy was developed in 6 months and a Phase 1 trial in healthy humans was completed in 2015.
During the 2018 Équateur province Ebola outbreak, a similar monoclonal antibody treatment, mAb114, was requested by the Democratic Republic of Congo (DRC) Ministry of Public Health. mAb114 was approved for compassionate use by the World Health Organization MEURI ethical protocol and at DRC ethics board. mAb114 was sent along with other therapeutic agents to the outbreak sites. However, the outbreak came to a conclusion before any therapeutic agents were given to patients.
Approximately 1 month following the conclusion of the Équateur province outbreak, a distinct outbreak was noted in Kivu in the DRC (2018–20 Kivu Ebola outbreak). Once again, mAb114 received approval for compassionate use by WHO MEURI and DRC ethic boards and was given to many patients under these protocols. In November 2018, the Pamoja Tulinde Maisha (PALM ["Together Save Lives"]) open-label, randomized clinical control trial began at multiple treatment units testing mAb114, atoltivimab/maftivimab/odesivimab (known as REGN-EB3), remdesivir, and ZMapp. Despite the difficulty of running a clinical trial in a conflict zone, investigators have enrolled 681 patients towards their goal of 725.
An interim analysis by the Data Safety and Monitoring Board (DSMB) of the first 499 patients found that mAb114 and REGN-EB3 were superior to the comparator ZMapp. Overall, the mortality of patients in the ZMapp and Remdesivir groups were 49% and 53% compared to 34% and 29% for mAb114 and REGN-EB3. …
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