The panel of 15 potent SARS-CoV2 neutralizing antibodies are potential therapeutics for COVID-19, said IONTAS, the company that detected the antibodies, in collaboration with FairJourney Biologics.
Working alongside vaccines, or as an alternative for those who respond poorly to vaccines, it is anticipated that monoclonal antibodies will play a vital role in the fight against COVID-19. Viral neutralizing antibodies can offer a two-in-one approach; to both treat symptomatic individuals and protect healthcare workers and at-risk groups.
“The virus gains entry into human cells through the interaction of a viral ‘spike’ protein interacting with a protein on the cell surface, called ACE. Our antibodies ‘block this door’ by binding to the spike protein and preventing this interaction with human cells,” John McCafferty, CSO, IONTAS, told BioPharma-Reporter.
The selected antibodies have picomolar potency and have been shown to block infection at doses as low as 20pM in pseudoviral assays and 100pM in live coronavirus assays, surpassing or matching the best antibodies reported, said the partners.
And their viral neutralization efficiency was independently verified by the National Institute for Biological Standards and Control (NIBSC), reported the CROs.
FairJourney Biologics and IONTAS announced their partnership to expedite the identification of effective antibodies for a therapeutic to treat COVID-19 patients in April this year. The project is part of an industry-wide collaboration under the antibody taskforce set up by UK’s BioIndustry Association (BIA).
Genes encoding anti-coronavirus antibodies
In an unparalleled timeframe of just two months, the partners said hundreds of virus-neutralizing antibodies were isolated and characterized from the blood of donors who were recovering from COVID-19.
“Patients fight the virus by generating antibodies. The antibody gene population from convalescent patients were harvested and we isolated the genes encoding anti-coronavirus antibodies using a technique previously invented by IONTAS' founder (the technique is called phage display).
“Once we have the antibody gene, we can readily produce the encoded human antibody. Doing this, we demonstrated that a number of the encoded antibodies are potent inhibitors of viral infection (using systems based on infection of cultured cells),” explained McCafferty.
The final panel of 15 potent SARS-CoV2 neutralizing antibodies are said to have biophysical properties well suited for downstream drug development, such as low polyreactivity and resistance to aggregation. That aspect reduces the risk for future clinical development and manufacturing, explained the CROs.
“We are now looking for partners to help develop these antibodies into life-saving drugs,” said McCafferty. He added that the antibodies would be administered by injection into the bloodstream.
Given the cost, scale and logistics of producing, testing and delivering antibody products to patients a likely partner would be a large pharmaceutical company.
In order to generate an antibody drug it is necessary to produce it under very carefully controlled conditions: “It would then have to progress through a standard clinical trials process, initially looking at safety and then efficacy of the antibodies in overcoming infection.”