What is Mapp Biopharmaceutical?
Mapp Biopharmaceutical was formed in 2003 to develop monoclonal antibodies for neglected infectious diseases and as countermeasures for biodefense threats. It is fully owned by its two scientist founders, with a commitment to develop therapeutics that advance public health even in the absence of an established commercial market. In addition to MBP134, Mapp has candidates for pan-marburgviruses and Nipah virus in advanced development and a wide range of earlier candidates for priority threats such as hantavirus, Crimean Congo Hemorrhagic Fever virus, botulinum neurotoxins, ricin and more.
What is MBP134?
MBP134 is an investigational monoclonal antibody cocktail that targets the surface glycoproteins of several filoviruses. The two monoclonal antibodies that make up MBP134 were isolated from a survivor of the 2014-2016 outbreak of Zaire ebolavirus (EBOV) in West Africa. Mapp used a process called “affinity maturation” to broaden the neutralizing activity of MBP134 to cover all known pathogenic ebolaviruses viruses affecting humans.
What are monoclonal antibodies?
Monoclonal antibodies are laboratory-produced versions of the protective antibodies generated by the immune system after infection or immunization. Scientists identify particularly potent individual antibodies from people or animals that have mounted a successful immune response and then manufacture those antibodies in large quantities as a medicine. Because they act immediately, monoclonal antibodies can be particularly useful after exposure or once someone is already infected.
Which viruses is MBP134 intended to target?
MBP134 was designed to target multiple members of the ebolavirus genus, including all Ebola viruses that are known to cause disease in humans. Laboratory in vitro studies confirm that it neutralizes Zaire ebolavirus (EBOV), Sudan ebolavirus (SUDV), Reston ebolavirus (RESTV), Tai Forest ebolavirus (TAFV), Bombali ebolavirus (BOMV) and Bundibugyo ebolavirus (BDBV), the species currently circulating in the Democratic Republic of the Congo and Uganda. In vivo studies demonstrate that MBP134 protects against Zaire ebolavirus, Sudan ebolavirus and Bundibugyo ebolavirus in relevant preclinical models (protection against other species of ebolavirus has yet to be tested in vivo).
Is MBP134 approved for use against ebolaviruses?
No. MBP134 remains an investigational product and has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities. Any use requires authorization from relevant regulatory and public health authorities.
Has MBP134 been tested in humans?
MBP134 has undergone Phase 1 clinical evaluation to assess safety and pharmacokinetics in healthy volunteers. The drug was found to be safe and well tolerated.
What evidence supports MBP134 as a therapeutic agent against ebolaviruses?
Published studies have demonstrated therapeutic protection against disease from multiple ebolaviruses, including Bundibugyo Virus Disease (BVD), Sudan Virus Disease (SVD), and Ebola Virus Disease (EVD, caused by Zaire ebolavirus) in preclinical models. While this suggests that MBP134 may provide clinical benefit to patients infected with one of these viruses, this has not been tested in an appropriately designed and powered clinical efficacy study.
Is MBP134 being used in the current Bundibugyo outbreak?
At this time, Mapp is not commenting on potential operational, regulatory, or deployment discussions. Any potential use of investigational therapeutics would occur in coordination with appropriate governmental, regulatory, and public health authorities.
Is MBP134 available commercially?
No. MBP134 is an investigational product and is not commercially available.
How is MBP134 different from previously approved Ebola therapeutics?
Currently approved Ebola therapeutics were developed against Ebola(EBOV) and, as such, are approved only for use in preventing infections or treating disease caused by that virus. MBP134 was specifically designed with the goal of broader activity across multiple ebolavirus species.
What role has the U.S. government played in development?
Development of filovirus countermeasures has involved collaboration among academic institutions, industry, and public-sector partners, including support from U.S. government agencies. The Defense Threat Reduction Agency (DTRA) funded the discovery of MBP134 and the Biomedical Advanced Research and Development Authority (BARDA) is funding advanced development through FDA licensure.
What is the current development status of MBP134?
Development activities remain ongoing. As is standard for investigational therapeutics, future development steps will depend on scientific, regulatory, operational, and funding considerations.
Why has MBP134 received attention during the current outbreak?
MBP134 has been discussed because published preclinical data suggest activity against Bundibugyo ebolavirus, for which there are currently no approved therapeutics.
Are there sufficient doses available for widespread use?
Mapp is not providing details regarding manufacturing capacity, inventory, supply chain, or operational preparedness. The existing doses are owned by the U.S. government.
Is MBP134 expected to work in humans?
It is important to avoid overinterpreting preclinical data. While the existing study results are encouraging, efficacy in humans has not yet been established.
Is Mapp Biopharmaceutical seeking approval for MBP134?
Mapp continues to evaluate potential development pathways in consultation with relevant stakeholders and regulatory authorities.