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Monoclonal Antibodies against 2019-New Coronavirus

Periodic Reporting for period 2 - MANCO (Monoclonal Antibodies against 2019-New Coronavirus)

Reporting period: 2021-03-01 to 2022-08-31

In response to the coronavirus disease 2019 (COVID-19) pandemic, also referred to as SARS-COV-2, tremendous efforts have been made to pull research initiatives together in order to accelerate the coordinated response against this coronavirus outbreak. MANCO is one of the 18 projects that was successfully selected by the European Commission, which is devoted to the development of Monoclonal Antibodies against the corona virus SARS2/COVID-19 for clinical use.
After some delay a number of monoclonal antibodies were generated successfully that block the infection of human cells by SARS2. Two of these were characterized extensively but were recently replaced as the preferred antibody for further development, because they were not effective in blocking the UK and South Africa variants of the virus. New immunisations were therefore carried out resulting in an antibody that blocks all variants including Omicron BA.1 and BA.2 Both mouse and hamster infection models have been established and tested. Due to the delay the project has successfully tested a novel production platform (C1, Dyadic) using the lead candidate antibody to go towards a clinical trial. This production platform cuts production costs considerably. The regulatory and ethical aspects are in place and a communication strategy has been developed.
Current progress beyond the state of the art is the development of an Antibody that blocks the infection of the important SARS2 variants and that could be used in combination with an existing antibody (47d11) to prevent the escape of novel viral variants. Importantly a novel and much cheaper production platform (C1) has been tested using the lead antibody. The C1 produced antibody has been tested successfully in hamster and non-human primate infection experiments both as a prophylactic and a therapeutic antibody. At the same time MANCO is in the process of obtaining regulatory approval.
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