Ebola virus virion

Regeneron Pharmaceuticals has entered an agreement with the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) to develop a monoclonal antibody therapy to treat Ebola virus infection.

In order to support preclinical development and antibody manufacturing, HHS will provide initial funding of $17m, which will also support an investigational new drug (IND) application with the US Food and Drug Administration (FDA).

Options included in the deal will see an additional $21m provided for a Phase I trial in healthy volunteers, which is planned for January next year, and further manufacturing and development studies.

The company has used its VelociGene and VelocImmune technologies, which allow the rapid identification and preclinical validation of fully human monoclonal antibodies, to develop a new antibody therapy combination of three antibodies.

Regeneron Research and Development executive vice-president Neil Stahl said: "In the midst of an emerging outbreak, every day counts for people who are infected or at risk.

"Regeneron’s technologies create manufacturing-ready cell lines of validated fully human antibodies in just months, offering the distinct promise of better treatments in shorter timeframes."

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The company said that these technologies allowed the rapid identification and scale-up of investigational antibody therapy.

So far, Regeneron has conducted pre-clinical studies in animal models of Ebola virus infection.

"Regeneron’s technologies create manufacturing-ready cell lines of validated fully human antibodies in just months, offering the distinct promise of better treatments in shorter timeframes."

According to the company, these antibodies have been discovered and developed according to its 2009 antibody discovery and development agreement with Sanofi and are subject to Sanofi’s opt-in rights for development and commercialisation.

As well as Ebola, the company’s antibody rapid response platform has been used to generate antibodies for Middle East Respiratory Syndrome (MERS) and has the potential to address other emerging infectious diseases.

In July, Regeneron and Sanofi entered a new global collaboration for new antibody cancer treatments in the emerging field of immuno-oncology.

The two companies will be responsible to jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase I testing and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programmes.

Under the deal, Sanofi will make an upfront payment to Regeneron of $640m, and the companies will invest $1bn for discovery through proof of concept (POC) development of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25% by Regeneron ($250m) and 75% by Sanofi ($750m).

Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.