Regeneron Pharmaceuticals, Inc. announced that Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) has been recognized as the "Best Biotechnology Product" of 2022 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition. The Prix Galien USA Award was presented in a ceremony in New York City.
"We are honored that the Galien Foundation has recognized Inmazeb, which was invented by Regeneron scientists committed to helping people impacted by the deadly Ebola virus," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Our ability to rapidly respond to Ebola was based on decades of deep investment in our enabling antibody technologies, starting with our remarkable VelocImmune® mouse. Our scientists realized that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola. The success with Ebola ushered in a new era in which monoclonal antibodies could be used to fight viral diseases and global pandemics."
"Our groundbreaking 'rapid response' application of our VelociSuite® technologies to address the Ebola outbreak laid the foundation for our COVID-19 efforts," said Christos Kyratsous, Ph.D., Senior Vice President, Research, at Regeneron. "By strategically pursuing a multi-antibody approach, parallel tracking certain steps and speeding hand-offs between groups, we are able to advance novel antibody treatments in a very expedited manner. Thank you for this recognition of the decades of diligent scientific research and technological investment that led to this important therapeutic discovery."
In October 2020, Inmazeb became the first therapy approved by the U.S. Food and Drug Administration (FDA) for Zaire ebolavirus. The three antibody combination neutralizes the Ebola virus by blocking the virus from entering into host cells via the glycoprotein and/or enables antibody-dependent effector function by bringing in other immune cells to target infected cells, which is a way for an antibody to get extra help from the immune system in order to clear infected cells from the body.
The safety and efficacy of Inmazeb was established through the 681-patient PALM (PAmoja TuLinde Maisha) Trial, a randomized, multicenter, controlled trial initiated in 2018 in the Democratic Republic of the Congo (DRC). The World Health Organization (WHO), the National Institutes of Health (NIH) and the Institut National de Recherche Biomédicale (INRB) in the DRC jointly sponsored and served as co-principal investigators of the trial. In 2019, as reported in the New England Journal of Medicine, the PALM Trial was stopped early following a pre-specified interim analysis that showed superiority of Inmazeb to ZMapp (another three antibody combination) and remdesivir (an antiviral) with respect to mortality. Adverse events (AEs) that occurred in at least 10% of Inmazeb patients were chills, elevation in fever (pyrexia), rapid heartbeat (tachycardia), rapid breathing (tachypnea), vomiting, low blood pressure (hypotension), diarrhea and inadequate oxygen supply to the tissue (hypoxia); of these, only chills occurred more frequently with Inmazeb than ZMapp. The evaluation of AEs in Inmazeb patients may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection.
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