What's Happening?
SK bioscience has entered into a licensing agreement with the Gates Medical Research Institute to develop and commercialize a monoclonal antibody (mAb) candidate for the prevention of respiratory syncytial
virus (RSV) infection. This agreement grants SK bioscience exclusive rights to commercialize the product in high-income countries and non-exclusive supply rights in India and Gavi-supported countries. The mAb candidate, engineered by Adimab in collaboration with Gates MRI, is designed to provide rapid and durable protection to newborns and infants during their first RSV season. Preclinical studies have shown promising results, and a Phase 1a study in the U.S. indicated safety and potential for sustained protection. SK bioscience plans to advance to a Phase 1b clinical trial in infants. The company aims to develop large-scale manufacturing processes to ensure affordable supply to low- and middle-income countries, addressing the high infant mortality rate associated with RSV in these regions.
Why It's Important?
The development of this RSV preventive mAb is significant as RSV is a leading cause of severe lower respiratory tract disease in infants, with a high mortality rate in low- and middle-income countries. The global market for RSV preventive antibodies is projected to grow significantly, reaching $4.5 billion by 2032. This initiative aligns with SK bioscience's commitment to global public health and equitable access to vaccines. By securing rights to this mAb, SK bioscience can potentially fill existing gaps in RSV protection, especially in resource-limited settings where current preventive measures are either costly or inaccessible. This development could lead to broader immunization coverage and reduced infant mortality rates globally.
What's Next?
SK bioscience plans to proceed with a Phase 1b clinical trial in infants to further evaluate the safety and efficacy of the mAb candidate. The company will also focus on developing large-scale manufacturing processes to ensure the mAb is affordable and accessible in low-resource settings. As the global demand for RSV prevention continues to rise, SK bioscience's efforts could lead to the inclusion of this mAb in national immunization programs, further expanding its reach and impact. The company's strategic focus on technology-driven investment and global partnerships will be crucial in driving sustainable growth and enhancing its competitive portfolio.
