Sr. Principal Scientist Merck & Co., Inc. Boston, Massachusetts
Immunotherapies have historically been evaluated for preclinical safety in non-human primate models, owing to their close functional homology between the NHP and human immune system and availability of assay reagents to interrogate immune effects. Here we report the conduct of exploratory and GLP toxicology studies performed on a small molecule immune agonist in the beagle dog. The dog ultimately proved valuable to the risk assessment supporting FIM clinical trials. Our experience indicates that the beagle dog should be considered as a relevant non rodent species for small molecule immunotherapies.
At the end of this presentation, the participant will appreciate additional considerations in preclinical safety species selection for FIH-enabling toxicology programs.
At the end of this preesntation, the participant will learn of immune parameters characterized in the dog.
At the end of this presentation, the participant will learn of non-traditional preclinical strategies to support clinical trials with novel therapeutics.