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SK Bioscience Submits IND for Phase 1/2 Clinical Trial of New Influenza Vaccine Candidate

Strategic Insights

— 1 min read

South Korea-based vaccine and biotech company SK bioscience has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a Phase 1/2 clinical trial of a new influenza vaccine candidate, NBP607B. This candidate incorporates an adjuvant into its existing cell-based influenza vaccine, SKYCellflu, to enhance protective efficacy. The adjuvant, developed by the Vaccine Formulation Institute (VFI), 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, with the Phase 1/2 clinical trial scheduled to begin during the upcoming Northern Hemisphere flu season.

Key Takeaways:

  • SK bioscience has submitted an IND application to the MFDS for a Phase 1/2 clinical trial of a new influenza vaccine candidate, NBP607B.
  • The candidate incorporates an adjuvant into its existing cell-based influenza vaccine, SKYCellflu, to enhance protective efficacy.
  • The adjuvant, developed by the Vaccine Formulation Institute (VFI), comprises multiple immune-boosting components and 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 will enroll approximately 320 older adults in Korea and abroad and will evaluate the vaccine's immunogenicity and safety compared to an approved high-immunogenicity flu vaccine.
  • Interim results are expected by 2027.
  • This is the first attempt by a Korean company to submit an IND to develop a high-immunogenicity influenza vaccine using an adjuvant.
  • SK bioscience plans to leverage the platform for other vaccines and establish a competitive edge in the global high-value vaccine market.

Statistics:

  • The Phase 1/2 clinical trial will enroll approximately 320 older adults in Korea and abroad.
  • SK bioscience has conducted non-clinical studies since 2023 and reported promising results.
  • Interim results are expected by 2027.
  • The Northern Hemisphere flu season is expected to begin soon, with the Phase 1/2 clinical trial scheduled to take place during this time.

Sources:

  • M2 PHARMA-July 18, 2025-SK bioscience submits IND for Phase 1/2 clinical trial of new influenza vaccine candidate
  • Ministry of Food and Drug Safety (MFDS)

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