Last year, the 100th monoclonal antibody product was approved for use by the FDA, however only a small fraction of these are designed for use against infectious diseases. The development of chimeric, humanised and human monoclonal antibodies (mAbs) for infectious diseases has been slower than hoped, but with several innovations in biomanufacturing, expression tools, improved understanding of host-pathogen interactions, immunomodulation, and fewer safety concerns, there is promise that more candidate mAbs will reach and perform well in clinical trials.
mAbs have been approved for infectious diseases treatment, and several treatments are in development targeting, amongst others, malaria, clostridia, dengue, leishmaniasis, hepatitis, staphylococcus aureus, influenza, with recent approvals granted for COVID-19 treatments in several countries. For many of these diseases, where resistance to the current crop of drugs impairs effective treatment, the study and development of monoclonal antibodies has emerged as an important research avenue for new therapies. However, there are technical, regulatory and commercial limitations that need to be explored and overcome before a greater number of mAbs are available in the therapeutic arsenal.
Pathogens and Global Health (PGH) is calling for submissions of research and review papers related to the development of monoclonal antibody therapies, in particular related to:
- approaches for target selection, including bioinformatics
- mechanisms of action
- clinical trials, design and dose selection
- production processes
- clinical application
- impact modelling
