Regeneron’s Inmazeb named Galien’s Best Biotech Product

by Stephen Riddle

The Galien Foundation, which acknowledges “extraordinary scientific innovations that improve the human condition”, has awarded its Best Biotechnology Product 2022 accolade to Regeneron Pharmaceuticals, Inc.’s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). It is the first FDA-approved treatment for Zaire ebolavirus.

The 16th annual Prix Galien USA Awards Gala ceremony was held in New York City last week, at the American Museum of Natural History. Dr George D. Yancopoulos, Regeneron’s chief scientific officer, said: “We are honoured that the Galien Foundation has recognised Inmazeb […] Our ability to rapidly respond to Ebola was based on decades of deep investment in our enabling antibody technologies.”

Yancopoulos continued: “Our scientists realised 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.”

Indeed, Regeneron believes that the success with Ebola could potentially have ushered in “a new era in which monoclonal antibodies could be used to fight viral diseases and global pandemics.”

Those technologies included the VelocImmune mouse and the VelociSuite. Patented in 2012 and 2013 in Europe and the US, respectively, VelocImmune humanised mice are genetically modified mice that have unrearranged human immunoglobulin variable region gene segments at endogenous mouse immunoglobulin loci. These mice contain the “full repertoire” of human heavy chain immunoglobulin genes and kappa light chain genes, each linked to the endogenous mouse constant regions. The “normal and robust” immune response exhibited has become what is considered to be the “gold standard” for developing human antibody therapeutics.

Meanwhile, discussing the company’s VelociSuite technologies, Christos Kyratsous, PhD, senior vice president of research at Regeneron, said the application of those technologies “to address the Ebola outbreak laid the foundation for” the company’s COVID-19 efforts.

The FDA-approved Inmazeb (previously known as REGN-EB3) in October 2020, making it the first FDA-approved therapy for the Ebola virus.  A three-antibody combination, Inmazeb – created using the VelocImmune platform and the VelociSuite technologies – neutralises the Ebola virus by blocking it 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. It is administered as a single, weight-based intravenous infusion (50mg atoltivimab, 50mg maftivimab, and 50mg odesivimab per kg).

Inmazeb’s safety and efficacy was established via the PALM (Pamoja TuLinde Maisha) Trial, a 681-patient, randomised, multi-centre, controlled study begun in 2018 in the Democratic Republic of Congo (DRC). Jointly sponsored by the World Health Organization (WHO), the National Institutes of Health (NIH), and the Institut National de Recherche Biomédicale (INRB), in 2019 the New England Journal of Medicine published a report which stated the PALM Trial’s early cessation. This was following a pre-specified interim analysis that exhibited Inzameb’s clear superiority to alternative three-antibody combo ZMapp, as well as the antiviral remdesivir, with respect to mortality.

The USA Awards Committee was composed of 10 renowned leaders from the biomedical industry and academia, including two Nobel Laureates. The Prix Galien is regarded as the equivalent of the Nobel Prize for the life science industry. Amgen, Inc. took Best Pharmaceutical Agent for LUMAKRAS, Aurion Biotech tool the Startup Pharma/Biotech category, and Exscientia was named the Best Digital Health Solution.

Bruno Cohen, chairman of The Galien Foundation, said: “[A]ll members […] applaud the unwavering commitment of each winner and award nominee in their quest to provide a healthier future for the next generation.”

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