SEPTEMBER 2021LIFE SCIENCES REVIEW8IN MY OPINIONBy Ralph Gareus, Director Business Development, The Jackson LaboratoryDE-RISKING THE PRECLINICAL PHASE OF IMMUNOTHERAPY DRUG DEVELOPMENTxploiting the power of a patient's immune system has brought a breakthrough in terms of specificity and efficacy in cancer therapy, significantly improving therapy success and quality of life for patients. While much more specific in their mode of action and frequently more potent than small molecules, immunomodulatory antibody therapeutics bring about new challenges for their preclinical development. For example, most animal models cannot be used to reliably determine human antibodies' pharmacodynamic (PD) and pharmacokinetic (PK) properties. Also, the majority of antibodies are precise for their human targets, and their efficacy cannot be tested in traditional models such as mice and rats.For years, The Jackson Laboratory (JAX) has been leading the development, validation, and application of new preclinical tools for the successful selection of the antibody variants with the best PK/PD, efficacy, and safety profiles.Therapeutic antibody PK determinationPioneering work by Derry Roopenian of JAX showed that, due to the different affinities of the human E
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