With some delay a number of monoclonal antibodies were generated successfully that blocked the infection of human cells by SARS2. Two of these were characterized extensively but had to be replaced as the preferred antibody for further development, because they were not effective in blocking the UK and South Africa variants of the virus that appeared later. New immunisations were therefore carried out resulting in an antibody 87G7 that blocked all variants including Omicron BA.1 and BA.2 Both mouse and hamster infection models were established and the antibody was tested successfully in these animal models. Due to the delay a change of the project was proposed because the antibody strategies were overtaken by the development of anti-Covid 19 vaccines. After approval by the EU and the Manco scientific advisory board it was decided to test out a new production platform for monoclonal antibodies that is faster and much cheaper which if successful would put antibody therapeutics with reach of poor and low-income countries for all type of diseases that would benefit from an antibody therapy. The project was therefore successfully changed to a novel fungal production platform, called C1 that was developed by Dyadic. The lead candidate antibody 87G7 produced by the C1 platform was compared to the traditional mammalian cell produced 87G7 biochemically and structurally in vitro and prophylactically and therapeutically tested in 3 animal models in vivo, mice, hamsters and non-human primates (NHP) to go towards a clinical trial. These tests were successful and the C1 generated 87G7 antibody was shown to be completely safe and effective in all models including NHP. Thus, the production platform cuts production costs considerably. The regulatory and ethical aspects are in place and a communication strategy has been developed. However the lead candidate antibody 87G7 was not taken any further in development because yet novel variants of the omicron virus appeared which escape neutralization by the antibody and due to the successful development of vaccines there is no interest by pharmaceutical companies to develop antibodies for treatment. The C1 antibody results have been submitted for publication.
