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Regeneron to Develop Antibody Therapy for Ebola

Ebola virus budding on monkey kidney cells

Scanning electron micrograph shows Ebola virus budding on monkey kidney cells (Defense.gov)

21 September 2015. Regeneron Pharmaceuticals Inc. received a contract from the U.S. Department of Health and Human Services to develop an engineered antibody designed to treat Ebola infections. The initial $17 million contract from HHS’s Biomedical Advanced Research and Development Authority or BARDA covers initial development and testing work on the therapy, but the program could expand to a two-year deal that includes a clinical trial of the new drug, valued at $38 million.

Since the 2014-15 outbreak of Ebola in West Africa has subsided, World Health Organization and public health authorities worldwide are taking steps to prevent its recurrence. Their actions now are aimed at building treatment capacity and putting assets in place to better predict, prevent, diagnose, and cure the disease than before.

The BARDA contract with the Tarrytown, New York company aims to harness its previous work with “knockout mice” that produces lab animals with specific genes disrupted or engineered for preclinical lab testing. Regeneron says its VelociMouse program uses high-throughput technologies to quickly identify targets and produce mice with the genetic characteristics to validate those targets.

The company’s VelocImmune project takes that idea one step further into production of monoclonal or highly specific humanized antibodies. The genetically-engineered mouse becomes a living production line, says Regeneron, producing antibodies to respond that respond as a human to a specific pathogen, while not affecting the rest of the animal. The mouse antibody is then extracted and recombined with human genetic characteristics for testing as a therapy candidate.

Regeneron says an advantage it has over other techniques is speed. The company claims it can prepare fully-validated antibodies, configured in manufacturing-ready cell lines, in months instead of the years required for other methods. In addition to its work with Ebola antibodies, the company is using this process to produce treatments for Middle East Respiratory Syndrome or MERS.

The new $17 million contract with Regeneron supports the company’s preclinical R&D through its submission of an investigational new drug application — request to begin clinical testing — to the U.S. Food and Drug Administration. A second stage of the contract will fund an estimated  $21 million early-stage clinical trial. An option in the contract, worth $11.3 million, would support manufacturing of the antibodies.

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