Safety Evaluation of Biotechnology-derived Immuno-Oncology Therapies, Considerations in Species Selection for Pre-Clinical TestingWednesday, 2 November 2016 at 14:30 Add to Calendar ▼2016-11-02 14:30:002016-11-02 15:30:00Europe/LondonSafety Evaluation of Biotechnology-derived Immuno-Oncology Therapies, Considerations in Species Selection for Pre-Clinical TestingCancer Immunotherapy and Biofluid Biopsies 2016 in Boston, USABoston, USASELECTBIOenquiries@selectbiosciences.com Regulatory guidance requires pre-clinical evaluation of immuno-oncology therapies prior to first in human (FIH) trials. Evaluation of such drug candidates can pose many challenges when the compound is a biotechnology based product. Often biotech products are highly specific for human targets and bind the equivalent target in pre-clinical species with much lower affinity or the presence of the target in healthy pre-clinical toxicology species is expressed at much lower levels, or is absent, when compared to the disease state in humans. The intended pharmacological activity of the therapy, such as immuno-stimulation for check-point inhibitors, is only observed when the target is present above certain levels, making exaggerated pharmacology difficult to evaluate in the pre-clinical space. This presentation looks at the challenges of selecting suitable species for pre-clinical evaluation, covering topics such as the use of transgenic mouse models, homologues versus the human drug candidate, overcoming anti-drug antibody challenges and supplementation of in vivo work with in vitro / ex vivo cell based assays. |