South Korea-based vaccine and biotech company SK bioscience announced on Thursday that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a Phase 1/2 clinical trials of a new influenza vaccine candidate, NBP607B.

The company says that the candidate incorporates an adjuvant into its existing cell-based influenza vaccine, SKYCellflu, to enhance protective efficacy.

SK bioscience previously utilised adjuvants in its COVID-19 vaccine, SKYCovione, and now seeks to expand this technology to influenza vaccines as part of its broader platform strategy.

NBP607B contains an adjuvant developed by the Vaccine Formulation Institute (VFI), a Swiss-based non-profit vaccine research organisation. Comprising multiple immune-boosting components, the adjuvant is expected to induce strong immune responses and antibody production in elderly individuals. SK bioscience has conducted non-clinical studies since 2023 and reported promising results.

The Phase 1/2 clinical trial is scheduled to begin during the upcoming Northern Hemisphere flu season, enrolling approximately 320 older adults in Korea and abroad. The study will evaluate the vaccine's immunogenicity and safety compared to an approved high-immunogenicity flu vaccine, with interim results expected by 2027.

According to SK bioscience, this is the first attempt by a Korean company to submit an IND to develop a high-immunogenicity influenza vaccine using an adjuvant. If successful, the company plans to leverage the platform for other vaccines and establish a competitive edge in the global high-value vaccine market.