Identifying secondary effects and adverse events early is key to preventing expensive Phase I clinical failures. The BioMAP® Platform provides a simple, comprehensive in vitro solution that informs on both efficacy and safety of candidates, whether small molecules or biologics.
BioMAP provides a comprehensive menu of human primary cell disease models for testing candidates across 100’s of clinically relevant protein biomarkers. Results are compared to thousands of reference molecules for insights on mechanism-of-action, efficacy, and safety.
At any stage of drug discovery, and the earlier the better, BioMAP Diversity PLUS® with Toxicity Signature Analysis extends our flagship BioMAP Diversity PLUS service to include an informatics-rich analysis of your molecule’s biomarker profile against profiles of clinically approved and experimental drugs, grouped by similar known toxicities or adverse effects. The nine groupings of the BioMAP Toxicity Signature Analysis include Acute Toxicity, Immunosuppression, Skin Irritation, Liver Toxicity, Organ Toxicity, Skin Rash, Skin Sensitization, Thrombosis, and Vascular Toxicity. Our blog post describes this in more detail.
BioMAP Toxicity Signature Analysis was created to alert discovery program leaders to the toxicity potential of early pipeline molecules, beyond obvious findings such as cytotoxicity and antiproliferative effects. Candidate prioritization is easier, faster, and has greater possibility of clinical success with decisions based on quantitative assessment and a systems biology approach. The approach has application beyond drug discovery, and has been used by the US Environmental Protection Agency to assess toxicities of per- and poly-fluorinated molecules (PFAS) while satisfying US Food and Drug Administration (FDA) regulatory requirements for reduced animal testing.
BioMAP Toxicity Signature Analysis allows you to:
- Prioritize candidates from screening assays for triage, based on the likelihood of adverse effects
- Identify potential toxicities of lead candidates for SAR efforts
- Uncover toxicity mechanisms, including cardiac liabilities
- Gain valuable insights from discussion of your results with Study Directors
BioMAP Toxicity Signature Analysis Reveals Differential Safety Pharmacology
Figure. Differential safety pharmacology of clinical JAK2 inhibitors for myeloproliferative disorders (MPD). Four JAK2 inhibitors were tested in BioMAP Diversity PLUS with Toxicity Signature Analysis at the indicated concentrations. Observed toxicity/pharmacology signatures included Immunosuppression, consistent with efficacy in MPD and predictive of increased risk of infection in patients. Fedratinib and gandotinib, but not ruxolitinib and momelotinib, indicate Organ Toxicity.
Order BioMAP Diversity PLUS with Toxicity Signature Analysis (Item 89-0050-0903) to increase your likelihood of success in clinical trials with safer lead candidates, while satisfying regulatory guidelines to reduce the use of animal models.
