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In Vitro Safety Profiling of ADCs Using an iPSC-Derived Human Tissue Screen

In vitro safety profiling of ADCs using an iPSC-derived human tissue screen to support FDA roadmap for biologics​
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This poster presents Ncardia’s human iPSC-derived seven-tissue safety panel designed to evaluate off-target and on-target off-tumor toxicity of antibody–drug conjugates and other biologics.

The platform combines physiologically relevant human tissues to generate a mechanistically informed safety profile early in development, aligned with the FDA roadmap for biologics safety assessment. 

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  • A seven-tissue iPSC-derived screening panel representing heart, CNS, vascular endothelium, lung, liver, skin, and intestinal epithelium for evaluating tissue-specific toxicity risks

  • In vitro safety profiling of Cetuximab–MMAE, showing strong cytotoxicity in melanocytes consistent with the clinically observed skin toxicity of EGFR-targeting therapies 

  • Real-time cytotoxicity measurements using impedance-based assays to detect dose-dependent tissue responses across multiple human cell types

  • A human-relevant platform capable of identifying off-target and on-target off-tumor safety liabilities before clinical development 

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If your ADC program advances to IND, how early are you testing normal human tissues for potential safety liabilities?

 

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