The catastrophic phase 1 clinical trial of German biotech TeGenero's monoclonal antibody designed to activate the immune system's T cells has raised serious concerns about the adequacy of the preclinical tests routinely used during the development of novel biologic drugs.
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Sheridan, C. TeGenero fiasco prompts regulatory rethink. Nat Biotechnol 24, 475–476 (2006). https://doi.org/10.1038/nbt0506-475
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DOI: https://doi.org/10.1038/nbt0506-475