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Dendrimer-based nanotechnology carriers for targeted drug delivery The right drug, to the right place, at the right tim

Dendrimer-based nanotechnology carriers for targeted drug delivery The right drug, to the right place, at the right time. Deborah Ladenheim, PhD Vice President, Regulatory Affairs Avidimer Therapeutics www.avidimer.com. Overview. Requirements for targeted therapeutics

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Dendrimer-based nanotechnology carriers for targeted drug delivery The right drug, to the right place, at the right tim

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  1. Dendrimer-based nanotechnology carriers for targeted drug deliveryThe right drug,to the right place, at the right time Deborah Ladenheim, PhD Vice President, Regulatory Affairs Avidimer Therapeutics www.avidimer.com

  2. Overview • Requirements for targeted therapeutics • Use of AvidimersTM for drug delivery & tumor detection • Benefits of targeting with AvidimersTM • General regulatory considerations

  3. Challenges Facing Targeted Therapeutics • Targeted therapeutics must: • Diffuse out of vasculature (<20 nm) • Recognize target cells and bind with high avidity and specificityto extracellular binding domain • Internalize and intracellularly traffic to site of intended action • Avoid “normal” tissue • Remain intact until reaching its intended site of action • Carrier should be stable andbiologically inert Vessel Normal Cell Targeted therapeutic Cancer Cell

  4. Dendrimer platform Interior Void Dendrimer dendri (treelike branching) + meros (a part); ~5nm Core Generation Number Surface Groups

  5. Dendrimer Size Comparison

  6. Making an AvidimerTM Interior Void Dendrimer dendri (treelike branching) + meros (a part); ~5nm Core Generation Number Surface Groups AvidimerTM dendrimer + ligand + drug (and / or imaging agent) Drugs Ligands

  7. Fluorescein (imaging agent) Folic acid (amide-linked targeting agent) G5-polyamidoamine (dendrimer platform) Computer model of a tri-functional AvidimerTM Methotrexate (ester-linked cytotoxic agent)

  8. The Value of AvidimersTM for Drug Delivery • Molecules have a uniform size and shape • Globular, true nanoscale dendrimer platform (~ 5nm diameter) • Ability to move in and out of vascular pores and pass through the filter organs • Targeted drug delivery • Ligands on the surface direct the drug to target cells • Attachment of multiple drug molecules allow increased drug concentration within the cell • Improved therapeutic index • Improved efficacy over traditional therapies • Lower systemic toxicity to non-targeted cells • Potential for faster drug development • Well-known and/or approved drugs • Well-characterized targeting ligands

  9. General regulatory considerations for nanotechnology • Characterization and heterogeneity • Polymer/drug/ligand structure • Size • Stability • Environmental impact? • Develop nanotechnology expertise within the FDA • Public scrutiny

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