Prohylaxis of at risks persons with an ultrapotent SARS-CoV-2 neutralizing antibody. (COVID19-ANTIBODY)

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),

which causes COVID-19, has now spread all over the globe, infected

millions, and already killed more than 150.000 people. Elderly people

are most likely to develop severe disease and to die from COVID-19.

The aim of this project is to have a manufacturable, cost-effective,

ultrapotent SARS-CoV-2-neutralizing antibody ready for prophylactic

use in the most vulnerable individuals by May 2021. This biologic will

be injectable (subcutaneously or intramuscularly) and fill the gap

where, yet to come, COVID-19 vaccines will likely fail or perform

poorly, i.e. in elderly individuals. The antibody will comprise a single

domain antibody (also known as a nanobody) that targets the most

vulnerable site in the viral spike protein. This nanobody building block

will be fused to a human IgG1 Fc domain that carries half-life

extension mutations, an alteration that has already been introduced

in a multitude of clinically approved antibody-based biologics.

Moreover, we will demonstrate high yield manufacturability of this

SARS-CoV-2 neutralizing biologic in Chinese hamster ovary (CHO)

cells (the gold standard production system), develop a downstream

protein purification protocol, and demonstrate stability and antiviral

potency in vitro and in vivo, in the highly relevant hamster model.