SK began developing an innovative technology to prevent viral infections and relieve symptoms through intranasal spray
The spray is expected to be used as the first line of defense to prevent virus spread before vaccine development
The project is being funded by the Bill & Melinda Gates Foundation through a grant to IAVI and a subgrant to SK bioscience 

An international effort to prevent and treat respiratory virus infections is expanding its scope. SK bioscience prepares to respond to future life-threatening pandemics by accelerating development of a new concept of biopharmaceuticals supported by international organizations and in collaboration with world-renowned research institutes.

SK bioscience (CEO Ahn Jae-yong) announced that the company will initiate preclinical development of an innovative binder protein compound designed to prevent and treat COVID-19 when sprayed into nasal passages. International research institutes participating in the product’s development include IAVI, a nonprofit scientific research organization, and the IPD (Institute for Protein Design) at University of Washington School of Medicine, which generated the key antiviral protein through computational design. Research and development expenses for the project will be supported by the Bill & Melinda Gates Foundation with a grant to IAVI and subgrant to SK. 

The candidate antiviral spray, developed by SK bioscience with international cooperation, is intended to be used quickly and conveniently to block infection in a situation where a respiratory virus is rapidly spreading. When sprayed into the nose, a small protein creates a protective layer inside the upper respiratory tract to prevent the virus from penetrating into the body and may alleviate symptoms of an established infection by disrupting the virus’ ability to replicate. A similar method could potentially be applied to viral respiratory diseases by providing both preventive and therapeutic effects at once. The antiviral technology was published in the international scientific journal ‘Science’ in September 2020.

SK bioscience expects that the spray could contribute to slow the spread of a newly emerged respiratory virus once authorized as the first line of defense before vaccines or therapeutics are developed.

Nasal spray-type pharmaceuticals can be stored in normal refrigeration conditions, so manufacturing and distribution are relatively easy. They can be administered multiple times as multi-dose formulations. If clinical trials demonstrate that the SK bioscience nasal spray is effective, it could potentially contribute to more equitable access of antiviral therapeutics for respiratory viruses in urgent situations such as the COVID-19 pandemic and support preemptive global pandemic response strategies.

IAVI received a grant from the Bill & Melinda Gates Foundation for research and development of the antiviral nasal spray anded SK bioscience as a subcontractor. SK bioscience will receive about $2.2 million USD (about 2.65 Billion KRW) from IAVI to support early pre-clinical development costs. SK bioscience will use the funds for initial process R&D for production of the antiviral nasal spray.

The lead protein compound in the nasal spray was designed in Dr. David Baker’s lab at the IPD, and partly funded with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No HHSN272201700059C. Lauren Carter, a lead scientist the IPD, will support development activities with SK bioscience. Dr. Baker is a globally recognized researcher who has published over 500 research papers and been granted over 100 patents related to protein design research.

SK bioscience has already begun process development after finishing transfer of the technology for the candidate protein from the University of Washington. SK bioscience hopes to cooperate with its partners IAVI, and the IPD to establish a nasal spray platform for the prevention and treatment of respiratory viruses to expand the scope of the use.

Jae-yong Ahn, CEO of SK bioscience said, “If we secure differentiated antiviral prevention and treatment from this research, it could be possible to quickly respond to continuously evolving respiratory viruses. Our efforts to develop new medicines to prevent and treat life threatening infectious viruses are leading to various international cooperation, and through this, SK bioscience will leap forward as a global pharmaceutical company.”

Additional Relationships with IPD and Other Partners

In a separate partnership, SK bioscience co-develops ‘GBP510,’ a recombinant protein-based COVID-19 vaccine candidate with the IPD. The IPD has provided nanoparticle technology for GBP510. This vaccine development is related to SK bioscience´s long-term efforts in cooperation with international organizations such as the Bill & Melinda Gate Foundation and CEPI (Coalition for Epidemic Preparedness Innovation) to develop vaccines which can preemptively respond to future infectious disease.

With financial support from the Bill & Melinda Gate Foundation, SK bioscience also developed a typhoid conjugate vaccine with the International Vaccine Research Institute (IVI) in 2013, confirmed its efficacy and safety, and then submitted an biologics license application to the Ministry of Food and Drug Safety(KMFDS). SK bioscience is also conducting a phase 3 clinical trial of a rotavirus vaccine with PATH (Program for Appropriate Technology in Health.) In addition, SK bioscience is conducting a global phase 3 clinical trial of ´GBP510´, a COVID-19 vaccine under financial support from CEPI and a booster clinical trial at the same time. The commercialization for GBP510 is expected upon receipt of a biological license application approval and a WHO PQ (Pre-qualification) certification in the first half of 2022.

SK bioscience also utilizes the GBP510 platform funded by CEPI to develop a universal vaccine targeting a Sarbecovirus group which include SARS-CoV-2, SARS-CoV-1, and related variants. Last month, WHO conducted an academic session and invited related researchers from SK bioscience to discuss regarding development of vaccines against the Sarbecovirus group. SK bioscience plans to develop an effective vaccine against the entire Sarbecovirus group to establish a comprehensive response system that prevents the related viruses and variants at once.