ADME of Novel Modalities Synopsis

Dear Colleagues,

Over the past 20 years, the translation of basic research tools to clinically relevant therapeutic entities has accelerated, expanding the therapeutic tool box beyond conventional small molecule drugs. Currently, recombinant antibodies, genetically and chemically modified proteins, antibody-drug conjugates, de novo designed peptides, oligonucleotides, viruses, protein-degraders, as well as conventional small molecule drugs, are being pursued in the clinic and approved for disease treatment. These modalities not only offer alternative platforms for target intervention, but  expand the landscape for disease intervention, complimenting both the scope of druggable target space, and introducing novel biological mechanisms that can fundamentally remedy disease processes. The realization of these therapeutic opportunities requires an understanding of the physiological, biochemical, and biological barriers that control exposure to the drug target and resulting biological response. Consequently, the successful application of ADME and PK/PD to characterization of novel therapeutics needs to consider the unique attributes conferred by the therapeutic modality and the desired and potential off-target biological responses.

The theme of these issues is to highlight how barriers to exposure, and the translation of exposure to efficacy can change across different modalities. Examples of the interpretation of ADME and PK/PD will be presented in the context of mechanistic aspects of therapeutic action and biological barriers unique to specific modalities, supporting gene therapy and gene editing, immunomodulation, modulation of protein–protein interaction, and target inhibition/suppression.

Dr. Jerome Hochman
Dr. Vikram Sinha
Dr. Anna Kwiatkowska
Guest Editors

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