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Current immunogenicity testing of drugs considers only the ‘antigenicity’ of the drug molecule, i.e. the ability of a compound to stimulate antibody production. However, true immunogenicity must also take into account anything that can cause an immune response or generate the conditions to initiate an immune response (e.g. tissue damage). Any drug has the potential to cause unwanted tissue damage which in turn increases the probability of immune-mediated (secondary) pathology.

There are two key areas in tumour biology that must be considered when developing models to study the disease – tumour heterogeneity and the tumour microenvironment (TME). Current cancer models including cell lines, organoids or, more recently, in vivo patient-derived xenograft (PDX) models often fail to recapitulate these elements sufficiently, and so numerous new treatments that have been developed based on these models do not perform well when moved forward into the clinic.

Dr Davide D'Amico, Chief Executive Officer of ZeClinics provides his perspective on the impact of CRACK IT Solutions on the development and application of the ZeGlobalTox technology platform for drug development, and on ZeClinics business more generally.

Stemina Biomarker Discovery, Inc. has developed two reliable human stem cell-based assays for developmental toxicity screening.

devTOX quickPredict rapidly predicts the developmental toxicity potential of test articles with 89% accuracy (79% sensitivity, 100% specificity), while devTOX Discovery identifies changes in secreted metabolites to help identify mechanisms of toxicity. Both are available using human embryonic stem (hES) and induced pluripotent stem (iPS) cells.

Biosystems Technologies Ltd. have developed TruLarvTM, research grade Galleria mellonella larvae for use in chemical and drug development pipelines as early screens for assessing efficacy and toxicity.