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Respiratory syncytial virus (RSV) infections are the most common cause of hospitalization in early childhood, accounting for 57 000 to 120 000 hospitalizations each year in the United States. RSV is causing annual epidemics of bronchiolitis and pneumonia worldwide. In most cases the infection with RSV heals without sequelae, yet RSV infection can cause lung function deterioration and in some circumstances, years of recurrent wheezing or asthma may ensue. Overall RSV accounts for an estimated2% of the hospitalization rate among infants less than 1 year of age. This rate increases 4–5-fold among high-risk patients such as premature infants and those with chronic lung disease or complicated congenital heart disease.

Currently there is only one possibility to prevent infections of at-risk patients with RSV, namely immuno-prophylaxis with palivizumab/Synagis, marketed by MedImmune. However, the response to palivizumab is variable among individuals, and sometimes palivizumab fails to prevent RSV infections effectively.

Due to the lack of better antibodies, lack of effective anti-viral treatment and lack of an effective preventive vaccine for RSV, there is a substantial medical need for more efficacious prophylactic immunizations, e.g. by antibody.

Kenta Biotech had developed a fully human monoclonal antibody (KBRV201) derived from B-cells of a human donor. KBRV201 is of the human IgG1 isotype with specificity and very high affinity for the F-protein of human respiratory syncytial virus (hRSV). KBRV201 has been tested for recognition and neutralization of hRSV strains -A, -B and –Long, and KBRV201 could neutralize in vitro all strains tested with higher efficacy than other anti-F-protein mAb.

KBRV201 successfully recognizes 22 clinical isolates from children infected with RSV, including one isolate with a mutated F-protein. Overall KBRV201 has demonstrated superiority in every experiment performed, and KBRV201 is currently undergoing extensive testing in animal models.

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