Consortium in the Composition: Icosageni Grupp, AS Chemi-Pharm, OÜ Teadus ja tegu, Estonian University of Life Sciences and the University of Tartu Developed and Patented Technology for the Manufacture of Nasal and Throat Spray SARS-Cov-2 Bioblock Based on Antibodies Against Coronavirus SARS-Cov-2.

CONSORTIUM IN THE COMPOSITION: ICOSAGENI GRUPP, AS CHEMI-PHARM, OÜ TEADUS JA TEGU, ESTONIAN UNIVERSITY OF LIFE SCIENCES AND THE UNIVERSITY OF TARTU DEVELOPED AND PATENTED TECHNOLOGY FOR THE MANUFACTURE OF NASAL AND THROAT SPRAY SARS-COV-2 BIOBLOCK BASED ON ANTIBODIES AGAINST CORONAVIRUS SARS-COV-2.

In cooperation with Estonian companies and universities, a technology was developed that can be used to prepare a nasal and throat spray based on antibodies against SARS-CoV-2, which during initial research has shown its effectiveness in preventing coronavirus infection.

According to Professor Mart Ustav, who led the development of the new technology, their work is based on a preparation made from colostrum from hyperimmunized cows. “Colostrum has the best natural role in providing the newborn with primary protective immunity through antibodies produced by the mother’s body. For our part, we have developed a technology for purifying colostrum antibodies, which results in a preparation that can be used to make a nasal and throat spray, which in turn has the effect of preventing coronavirus infection,” Professor Ustav explained the positive effects of a novel product in the fight against coronavirus. Professor Ustav emphasized that it was not a drug but an antiviral preparation that works on the surface of the mucous membranes in the nasopharynx, where it can specifically inactivate the Covid-19 virus SARS CoV-2.

According to Prof. Ustav, preclinical tests have shown that the product produced had SARS CoV-2 virus-neutralizing activity. “We emphasize that these antibodies were effective not only against the virus strain that originated in Wuhan but also against new, more prevalent virus variants of Great Britain, South Africa, and Brazil, which we studied in biochemical as well as pseudovirus infection experiments. Animal experiments had shown that by instilling a solution of colostrum-derived antibodies in the nose one hour before infection with high levels of SARS-CoV-2, our preparation was able to significantly reduce the viral titer in the lungs. This indicates that the developed nasal and throat spray preparation is able to trap and neutralize the SARS-CoV-2 virus in the nasopharynx,” specified Prof. Ustav.

According to Ruth Oltjer, one of the leaders of the endeavor, the head of AS Chemi-Pharm, it is important to move quickly further from research. “The next step is for the consortium to conduct clinical trials and start producing SARS-CoV-2 BioBlock nasal and throat sprays containing the preparation as soon as possible,” Oltjer added. To this end, we have launched the production of SARS-CoV-2 BioBlock test batches and have submitted the protocols of the two clinical trials to the Research Ethics Committee of the University of Tartu for approval. These studies confirm the results of preclinical trials and provide a basis for the use of antiviral nasal spray as a prophylactic tool in the control of an extensive corona pandemic.

Ruth Oltjer added that the SARS-CoV-2 BioBlock could be helpful wherever social distancing is difficult: at homes, in restaurants, at schools, in sports practices, at sports competitions, at workplaces, in vehicles, and other crowded places. “It would be especially advisable to use the product on people that are in close contact with infected people, in order to reduce the risk of infection, as well as on infected people, so that these people would be less infectious to their loved ones,” Oltjer said, emphasizing that the SARS-CoV-2 BioBlock nasal and throat spray is not a substitute for vaccination or wearing a mask, but an additional measure to break the infection chains of the virus.

The consortium that developed the new technology includes Icosagen Grupp, AS Chemi-Pharm, University of Tartu (Institute of Pharmacy, Institute of Biomedical and Transitional Medicine and Institute of Technology), Estonian University of Life Sciences (Institute of Veterinary Medicine and OÜ Eerika farm), and OÜ Teadus ja Tegu.

Responsible composition of the consortium: Mart Ustav (Icosagen Group, mart.ustav@icosagen.com), Ruth Oltjer (AS ChemiPharm, ruth@chemi-pharm.com), Väino Poikalainen (OÜ Teadus ja Tegu, vaino.poikalainen@gmail.com), Toomas Tiirats (EULS, toomas.tiirats@emu.ee), Mario Plaas (UT, mario.plaas@ut.ee), Karin Kogermann (UT, karin.kogermann@ut.ee), Eva Zušinaite (UT, eva.zushinaite@ut.ee)

Tartu, March 15, 2021

Information in more detail:

A consortium consisting of Icosagen Grupp, AS Chemi-Pharm, University of Tartu (Institute of Pharmacy, Institute of Biomedical and Transplant Medicine and Institute of Technology), Estonian University of Life Sciences (Institute of Veterinary Medicine and Animal Husbandry), and OÜ Teadus ja Tegu have jointly developed technology to create a colostrum preparation to prevent coronavirus infection. The consortium plans to conduct clinical trials in Estonia and launch a nasal and throat spray, “SARS-CoV-2 BioBlock” containing this preparation.

This product is not a drug but an antiviral prophylactic preparation that acts on the surface of the nasopharyngeal mucosa, where it can specifically inactivate the Covid-19 agent SARS CoV-2 virus. SARS-CoV-2 BioBlock nasal and throat spray is not a substitute for vaccination or wearing a mask but is an additional measure to break viral chains. The SARS-CoV-2 BioBlock nasal and throat spray could be helpful wherever social distancing and wearing a mask is difficult: at home, at work, in a restaurant, at school, in sports practice, in a vehicle, and in other crowded places. It is recommended that the product also be used by infected people to reduce the risk of infecting people they are in close contact with. In addition, the preparation can be used to support new, more prevalent virus variants originating from the United Kingdom, South Africa, and Brazil.

The natural role of colostrum in mammals is to provide the newborn with primary protective immunity through antibodies produced by the mother’s body. Unlike humans, bovine antibodies are not able to cross the placenta, and a newborn calf acquires antibodies from its mother only with colostrum. After birth, calves are given colostrum for 24 hours on the farms, as a result of which the newborn acquire passive immunity to various pathogens (viruses, bacteria, and allergens) that spread in the herd. At the same time, only a small part (about 2 liters) of the colostrum produced after calving is used to reconstruct the immune system of calves – the rest is a largely unused resource. More than half of the whey proteins produced from the first colostrum are made up of high concentrations of antibodies, up to 500 grams of which can be obtained from there. The composition of antibodies in colostrum can be altered by immunizing pregnant cows using commercial vaccines or pathogen antigens, such as viral proteins, giving novel, specific protective effects to colostrum. This unique natural feature offers great potential for improving the resistance of newborn offspring to infectious diseases in the herd but also creates possibilities for the development of colostrum products beneficial for humans that can be used to prevent infections or allergies, thereby significantly improving people’s quality of life.

Our consortium used non-infectious recombinant SARS-CoV-2 spike protein to immunize cows during the third trimester of pregnancy, to which new anti-SARS CoV-2 virus neutralizing antibodies were developed in the blood of cows over time. The coronavirus spike protein used for immunization is similar to that used in human vaccines. As expected, just before calving, most of the antibodies developed went from the blood to the mammary glands and from there to the colostrum, which we used as source material for antibody production. We developed a technology for purifying colostrum antibodies, during which we removed lactose, the vast majority of milk proteins, and sterilized the preparation for possible viruses and bacteria by acid treatment, pasteurization, and membrane filtration. Last week, Icosagen filed a patent application with the U.S. Patent Office (No. 63/160833) on behalf of the consortium’s inventors to protect the technical process of the SARS CoV-2 virus-neutralizing antibody preparation. The commercial rights to the future patent will be distributed among the consortium partners in accordance with the intellectual property management agreement. In this patent application, we protect intellectual property for the use of such an antibody preparation as a nasal and throat spray to prevent infection with SARS CoV-2 or to reduce viral titer in the nasopharynx of infected individuals.

In preclinical experiments, we showed that the prepared preparation had SARS-CoV-2 virus-neutralizing activity in biochemical binding assays with the ACE2 receptor required for entry to a cell, in SARS-CoV-2 spike protein-dependent pseudo virus infection assays, and infecting VERO E6 cells with an Estonian isolate of coronavirus. We emphasize that these bovine antibodies were effective not only against the Wuhan-derived virus strain but also against new, more easily spreading virus variants from Great Britain, South Africa, and Brazil, which we studied in both biochemical and pseudo virus infection experiments. Experiments carried out with Syrian golden hamsters showed that when a colostrum solution was instilled into the nose of animals one hour before infection with a large amount (100,000 virus particles) of SARS-CoV-2, our preparation was able to significantly reduce the viral titer in the lungs. This indicates that the formulation contained in the generated nasal and throat spray is able to trap and neutralize the SARS-CoV-2 virus in the nasopharynx.

The members of the consortium have also initiated the SARS-CoV-2 BioBlock nasal and throat spray clinical trials program. To this end, we have launched the production of SARS-CoV-2 BioBlock nasal and throat spray test batches and have submitted the protocols of the two clinical trials to the Research Ethics Committee of the University of Tartu for approval. The first of these focuses on the study of the pharmacokinetics and bioavailability of nasal and throat sprays in healthy volunteers and will be conducted in collaboration with the University of Tartu Ear Clinic and the Clinical Trials Center in the coming weeks after receiving the ethics permit. The second, more extensive study has been initiated in collaboration with medical researchers from the Institute of Family Medicine and Public Health of the University of Tartu and focuses on the efficacy of SARS-CoV-2 BioBlock among individuals infected with SARS-CoV-2 and those who have been in close contact with the infected individuals. These studies allow us to confirm the results of preclinical trials on the efficacy of nasal and throat spray in the context of modulating and preventing human COVID-19 virus infection in real life and provide a basis for the use of antiviral nasal and throat spray as a prophylactic tool to control an extensive corona pandemic.