Alfasigma R&D presents a new inhalable antibody able to block COVID19

Developed by the researchers of Labio 4.0 of Pomezia and University of Rome Tor Vergata, it has been obtained from the blood of doctors of the Hospital of Bergamo infected during the pandemic emergency.

Thanks to the blood of ten doctors and health workers of the Hospital Papa Giovanni XXIII of Bergamo, a new synthetic anti-Covid 19 antibody has been obtained, which can be inhaled as an aerosol and represents an absolute novelty compared to those so far available only for injection. The study, all-Italian, which describes inhalable human antibody fragments effective against Sars-CoV-2, has just been published in the scientific journal Molecular Therapy and is the result of the work of a group of researchers from the multifunctional center for research and development Labio 4.0 Marino Golinelli in Pomezia of the Italian company Alfasigma and the Department of Biology of the University of Rome Tor Vergata.

The SOS launched from Bergamo: "We were in contact with the hospital of Bergamo for oncological projects and during the pandemic they asked us to try to find solutions", tell Rita De Santis and Olga Minenkova of the Biotechnology laboratory of Pomezia. "We received ten blood donations from doctors and health workers who had survived Covid-19, each with a different disease history."

At this point, the collaboration with Tor Vergata also began: "We provided the Alfasigma Biotechnology group with a useful reagent for the expression of the Sars-CoV-2 spike protein that we had just obtained from China and selected the most effective antibodies in blocking the entry of the virus into human cells", explains Maria Gabriella Santoro, Professor of Virology at Tor Vergata University in Rome.

The selection: Once they identified the three donors who had developed a more effective immune response against the virus, the researchers used their blood to isolate genes that encode for antibodies. "We thus identified six antibodies capable of neutralizing the Spike protein by preventing the virus from entering cells," continue researchers De Santis and Minenkova. "In mice infected with the pseudovirus, infection was no longer measurable 48 hours after administration of the antibody, while in mice that had not received the antibody or had received an inactive antibody used as a control, infection continued to increase.

Efficacy against all variants and "inhalable" formulation: In the study just published in Molecular Therapy, these synthetic 'mini-antibodies' were studied for their properties of inhibiting virus binding to cells and for their ability to counteract virus infection in both cellular and animal models. "The study in fact - explains Santoro - shows that this antibody recognizes a portion of Spike that is essential to the function of virus entry into cells. It would thus be able to counteract, even at very low doses, all variants of Spike known at the time of the study and the infection in the airways through administration in the nasal cavities".

"Our competitive advantage lies in the fact that we have selected only the strongest and most resistant antibodies, therefore suitable to be used in aerosol. - adds De Santis - The possibility of such an easy administration, compared to intravenous administration, and the effectiveness at very low doses is revolutionary because it would allow a sort of 'self-management' of the patient with a reduction of hospital costs".

The next steps: From this Italian study to the arrival of the development of an antibody that can be inhaled and is effective, how long will it take? "Generally, the development of a new drug takes several years to reach clinical use. However, during this pandemic, production, testing and approval times have been greatly reduced due to the emergency, as also seen in the production and use of vaccines", Santoro concludes. Now the researchers are waiting for the efficacy results on Omicron that already seem to be very promising.


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