BioMAP® Phenotypic Safety and Toxicology Services
Identifying secondary effects and adverse events early is key to preventing expensive Phase I failures. BioMAP Phenotypic Profiling Services provide a simple, comprehensive in vitro solution that informs on both the efficacy and safety of a compound. With a comprehensive menu of tissue and disease biology to choose from, you can understand the impact of your compound across 100’s of clinically relevant protein biomarkers and compare its performance and mechanistic behavior to over thousands of reference compounds. The end result is physiologically relevant insights into the efficacy, safety, and adverse effects of your candidates to give you better confidence in selecting compounds to progress into the clinic.
BioMAP Phenotypic Profiling Highlights
BioMAP Phenotypic Profiling Service Offering
- Human primary cell for data relevant to human biology
- Identify off-target effects and predict potential adverse events
- Inform preclinical design and biomarker selection for smooth transition into trials
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- Diversity PLUS® Panel – a tool for safety screening on a platform that is the next best thing to testing on a human patient
- Tox Alert™ Panel – an in silico analysis that can identify potential adverse events prior to going to trial
Earlier Identification of Unwanted Secondary Effects and Adverse Events Immuno-Suppression Acute Toxicity Potential Toxicity
BioMAP Service Offerings for Safety Profiling
Diversity PLUS Panel
The Diversity PLUS panel is a method of phenotypic profiling that enables the correlation of compound activity with clinical outcomes by providing insight into mechanisms of action, dosing, efficacy, and safety-related effects. To achieve this, the platform uses stimulated human primary cell-based assays (BioMAP systems) to recapitulate human disease that can be “treated” with your compound. The resulting changes in 148 biomarkers form a biomarker profile for the compound. By comparing your compound’s biomarker activity profile against a reference database of more than 4,500 compounds, the BioMAP platform can provide you with the highly valuable insights needed to make the best decisions regarding compound advancement.
Trametinib (Mekinist™ or GSK-1120212), a MEK1/2 inhibitor approved for the treatment of metastatic melanoma, profiled at 4 concentrations (red, orange, yellow and green) in the BioMAP Diversity PLUS Panel. Trametinib decreased proliferation and increased VEGFR2 expression in two models of vascular inflammation (3C and 4H) and decrease PAI-1 in a lung inflammation model. These changes can be attributed to efficacy of Trametinib in patients. Additionally, decreases of IL-8 and increases in VCAM-1 have been identified as important signatures in drugs that are associated with infections or skin rash (respectively). The remaining annotated peaks represent biomarker readouts that demonstrate statistically significant change during treatment as compared to historical controls (the range of historical vehicle control data is represented by the grey region closest to the axis).
Tox Alert Add-On Analysis to Diversity PLUS
Tox Alert Analysis uses data from compounds profiled in the BioMAP® Diversity PLUS™ panel of human disease models spanning 148 clinical biomarkers and analyzes them in two ways:
- Identifies biomarker signatures that correlate with important adverse effects seen in the clinic and animal studies
- Classifies compounds using machine learning algorithms into one of 28 mechanism classes such as corticosteroids, selective kinase inhibitors, proteasome inhibitors, microtubule stabilizers, and mitochondrial disrupters