Researchers at Vanderbilt University Medical Center (VUMC) are partnering with the Dutch biopharmaceutical firm Batavia Biosciences and Nashville-based IDBiologics to bring to the clinic a highly potent Zika virus neutralizing antibody they isolated three years ago.
The mosquito-borne Zika virus is believed to cause microcephaly, unusually small heads, and other congenital malformations in children born to infected women. Currently there is no way to prevent Zika virus infection or its aftermath.
Batavia Biosciences announced today that it has signed a license agreement to utilize a cell line expression system developed by Horizon Discovery, a life sciences company based in Cambridge, England, for development of high-yield, antibody-expressing cell lines.
Initially Batavia will deploy the system to produce the anti-Zika antibody in collaboration with VUMC and IDBiologics, which is using a proprietary platform to discover and develop human antibodies for the treatment and prevention of infectious diseases.
We're excited to work with Batavia to move this promising Zika antibody therapy one step closer to the clinic. Preparing state-of-the-art antibody drugs requires interdisciplinary teams, and Batavia, IDBiologics and Vanderbilt bring together the important elements to make this project happen."
James Crowe Jr., MD, director of the Vanderbilt Vaccine Center and co-founder of IDBiologics
In 2016 VUMC researchers in collaboration with colleagues at Washington University School of Medicine in St. Louis reported the isolation of a human monoclonal antibody that in a mouse model "markedly reduced" infection by the Zika virus.
Dubbed ZIKV-117, the antibody binds to an "epitope" or part of the Zika virus in a way that no previous antibody has.
"The 'Achilles heel' of this virus is the epitope that the antibody binds," said Robert Carnahan, PhD, director of the Vanderbilt Antibody and Protein Resource. "This is a very special antibody. We're pretty excited about it."
Most antibody drugs are produced in permanent Chinese hamster ovary (CHO) cell lines. The standardized manufacturing process is highly regulated in the United States by the Food and Drug Administration and is a key step to obtaining approval to conduct clinical trials of new antibody drugs in humans.
Producing CHO lines is very difficult and expensive to achieve. The GS knockout CHO K1 cell line expression system developed by Horizon Discovery is an efficient method of selecting high-expressing clones of cells that produce the desired monoclonal antibody.
Crowe is the Ann Scott Carell Professor in the Departments of Pediatrics and Pathology, Microbiology & Immunology in the Vanderbilt University School of Medicine. Carnahan is associate professor of Pediatrics and of Radiology and Radiological Sciences.
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