SK Bioscience applies Phase 3 trials in US for pneumococcal vaccine

South Korea's SK Bioscience Co. announced on Monday that it submitted the Investigational New Drug (IND) application for the Phase 3 clinical trial plan of the 21-valent pneumococcal protein conjugate vaccine candidate GBP410, developed in collaboration with Sanofi SA, to the US Food and Drug Administration (FDA).

In August this year, SK Bioscience and Sanofi completed the Phase 2 clinical trial of GBP410. The trial involved administering GBP410 and a comparator vaccine (Prevenar 13) to 140 infants aged 12-15 months and 712 infants aged 42-89 days, confirming the immunogenicity of GBP410. No vaccine-related serious adverse events were reported.

SK Bioscience and Sanofi plan to complete Phase 3 clinical trials targeting infants in multiple countries, including the United States, Europe, and South Korea by 2027.

"Annually, 740,000 infants, children and adolescents die from pneumonia worldwide," Ahn Jae-yong, CEO of SK Bioscience said. "Through the development of GBP410, we aim to contribute to global public health and grow into a leading company in the market."

Write to Ji-Hyun Lee at bluesky@hankyung.com