Monoclonal Antibody for RSV Prevention

This project aims to develop an affordable, long-acting monoclonal antibody (RSM01) for the prevention of respiratory syncytial virus (RSV) in infants, with a focus on improving access in low- and middle-income countries (LMICs). Existing preventive options are limited by high cost and delivery constraints, restricting their use in these settings. The project’s core objective is to establish proof-of-concept through a Phase 1b clinical trial in infants, assessing safety, tolerability, pharmacokinetics, and immunogenicity (including anti-drug antibodies) of a single-dose regimen. The study will also generate early data to inform dose selection and clinical potential. In parallel, the project lays the groundwork for cost-efficient large-scale manufacturing to enable future affordability and access in LMICs