SK bioscience Takes a Big Step with New Influenza Vaccine Candidate IND Submission

SK bioscience's New Influenza Vaccine Initiative



SK bioscience, a prominent name in the global vaccine and biotech industry, is on the verge of an important advancement in influenza vaccination. Recently, the company announced the submission of an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety in South Korea, proposing the commencement of Phase 1/2 clinical trials for a new influenza vaccine candidate named 'NBP607B'. This particular vaccine integrates an adjuvant into its existing cell-based influenza vaccine platform, known as 'SKYCellflu', which has been recognized for its innovative approach to combating influenza.

The initiative is focused on enhancing the vaccine's protective efficacy, particularly for those most at risk, including older adults. Adjuvants are substances that are added to vaccines to boost the body's immune response to the provided antigens, effectively making the vaccine more effective. Earlier, SK bioscience successfully employed adjuvants in its COVID-19 vaccine, 'SKYCovione', and the company is now keen on expanding this technology to tackle influenza.

The adjuvant utilized in the NBP607B candidate is a product of a collaboration with the Vaccine Formulation Institute (VFI), a respected non-profit organization based in Switzerland. This adjuvant is designed to enhance immune responses and antibody production, making it particularly suitable for elderly individuals who may require more robust protection against influenza viruses.

Since 2023, SK bioscience has conducted non-clinical studies, yielding promising results that highlight the potential of NBP607B. Following this, the Phase 1/2 clinical trial is scheduled to initiate during the upcoming Northern Hemisphere flu season, with plans to enroll around 320 older adults both in Korea and internationally. Throughout the study, the objective will be to assess the immunogenicity and safety of the new vaccine when contrasted with an approved high-immunogenicity flu vaccine, with interim results anticipated by 2027.

With this milestone, SK bioscience becomes the first Korean entity to pursue IND approval for a high-immunogenicity influenza vaccine that employs an adjuvant. The successful development of NBP607B could significantly enhance the company's portfolio and provide a competitive advantage in the burgeoning global vaccine market. According to market analysis by Mordor Intelligence, the global vaccine market is projected to expand from USD 83.9 billion in 2025 to USD 114.8 billion by 2030, with a notable annual growth rate of 6.5%. As the population ages and the incidence of immunocompromised individuals rises, the demand for effective vaccines is likely to continue ascending.

SK bioscience's commitment to innovation is evident through its existing influenza vaccine, SKYCellflu, which made history as the world's first cell-based flu vaccine to receive prequalification from the World Health Organization (WHO). Currently, it has been approved in 11 different countries and is distributed through international procurement channels by agencies such as UNICEF and the Pan American Health Organization (PAHO).

Jaeyong Ahn, the CEO of SK bioscience, commented on this journey, stating, "The integration of our proven SKYCellflu platform with our expertise in developing adjuvanted vaccines places us in a strong position for future successes. Our goal is to carve out a distinct presence in the high-immunogenicity vaccine market, alongside establishing a versatile platform for preparedness against infectious disease challenges."

The global health landscape is increasingly leaning towards improved vaccine options for high-risk groups. Health authorities including the U.S. Centers for Disease Control and Prevention (CDC) recommend high-dose or adjuvanted influenza vaccines for individuals aged 65 and older, a sentiment echoed by the World Health Organization (WHO). Likewise, in South Korea, the Korea Disease Control and Prevention Agency (KDCA) indicates that domestically developed high-immunogenicity vaccines may enhance public health measures if they meet specific criteria.

As SK bioscience embarks on this promising clinical trial, the future of influenza vaccination looks increasingly bright, potentially setting new benchmarks for vaccine efficacy and community health protection.

Topics Health)

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