The past two decades have seen the arrival of revolutionary new biologic therapies for the treatment of numerous diseases, including inflammatory, hematologic, and malignant conditions. The majority of innovative biologics medicines have been monoclonal antibodies (MAbs), which continue to be developed for the treatment and prophylaxis of a growing variety of diseases. Despite these tremendous advances and outstanding potential, only two MAb products in the infectious disease arena, AstraZeneca/Medimmune’s Synagis, which has established itself as the standard for the prevention of respiratory syncytial virus (RSV) infections in high-risk infants, and GlaxoSmithKline’s Abthrax for the treatment and prevention of inhalation Anthrax, have reached the market. Nonetheless, MAbs hold the promise of prevention and/or treatment of a host of bacterial and viral infections, thanks to the potential for less frequent dosing, improved safety, synergistic activity with small molecule therapies, and lower selective pressure leading to the emergence of resistance.
This report explores the opportunities and challenges in the quest to develop MAbs for the treatment and prevention of infectious diseases, including bacterial infections due to Clostridium difficile, Pseudomonas aeruginosa, and Staphylococcus aureus, as well as viral infections due to RSV and influenza, among other pathogens. The study evaluates the current pipeline and developers’ strategies for clinical development of MAbs in infectious diseases and makes actionable recommendations on the path forward for bringing to market new MAb therapies and prophylactic agents in this therapeutic space.