#South Korea #RSV #Incheon #SK bioscience #Gates Medical Research

SK bioscience and Its Commitment to RSV Prevention

In a significant step towards enhancing global health initiatives, SK bioscience has recently announced its plans to advance a novel monoclonal antibody (mAb) aimed at preventing respiratory syncytial virus (RSV) infections. This initiative is made possible through a licensing agreement with the Gates Medical Research Institute (Gates MRI), a nonprofit organization affiliated with the esteemed Gates Foundation.

The RSV mAb candidate, engineered through a collaboration between Adimab and Gates MRI, is designed for administration to newborns and infants during their initial RSV season. This approach allows for a single dose that is intended to provide both rapid and lasting protection throughout the RSV season. This is crucial, as current prevention methods face limitations, particularly with maternal immunization protocols that may not reach every infant effectively.

In preclinical studies, the mAb has exhibited a strong capacity to inhibit RSV infection and replication, with positive results across both in vitro and in vivo tests. Moreover, it showed effectiveness against certain RSV strains that have demonstrated reduced susceptibility to existing preventive options on the market.

The recent first-in-human Phase 1a clinical trial, conducted with healthy adult participants, revealed that the mAb candidate was generally safe and well-tolerated. Encouraging data from this trial suggests the possibility of extended protection throughout the RSV season, leading SK bioscience to expedite the transition into a Phase 1b clinical trial involving infants.

Under the agreement with Gates MRI, SK bioscience has secured exclusive global rights to commercialize the mAb if the clinical trials confirm its safety and efficacy. What sets this partnership apart is the commitment to ensuring that the mAb is accessible not just in high-income countries but also in India and nations supported by Gavi. Additionally, there are obligations in place for charitable Global Access initiatives aimed at bridging the gap in healthcare disparity.

SK bioscience's plan goes beyond commercialization; it includes advancing large-scale manufacturing processes. This step is particularly vital for ensuring that the mAb is affordable and accessible to low- and middle-income countries, where the impact of RSV is considerably high. Reports indicate that RSV is responsible for around 100,000 infant deaths annually, predominantly in regions with limited healthcare resources, thereby highlighting the urgent need for effective preventive measures.

The global market for RSV preventive options is on an upward trajectory, projected to reach $4.5 billion by 2032. The World Health Organization (WHO) has identified this market as a priority, noting that demand for RSV antibodies will likely escalate with increased affordability and integration into national immunization programs. This further underscores the importance of SK bioscience's mAb candidate in addressing a critical public health need.

Jaeyong Ahn, the CEO of SK bioscience, articulated the organization’s vision, stating that this innovative mAb candidate is strategically aligned with public health imperatives, emphasizing both commercial opportunities and humanitarian commitments. As the company continues to expand its technological capabilities and foster global partnerships, it remains focused on sustainable growth and the promotion of equitable healthcare access worldwide.

With an unwavering commitment to advancing global public health, SK bioscience has previously collaborated with the Gates Foundation on various initiatives aimed at developing affordable vaccines for low-income regions, including interventions for typhoid fever and COVID-19. This partnership is just the latest chapter in their ongoing mission to enhance health standards across the globe, ensuring that vulnerable populations are not left behind in the fight against preventable diseases.

Thus, as SK bioscience embarks on this promising journey to develop an effective RSV preventive mAb, the global health community watches keenly, hopeful for a significant reduction in RSV-related infant mortality rates in the near future.

About SK bioscience

SK bioscience is a pioneering vaccine and biotech company dedicated to promoting equitable access to vaccines worldwide. By leveraging advanced technologies and collaborating with various stakeholders in the healthcare system, SK bioscience strives to provide high-quality vaccines and healthcare solutions for those who need them the most.