Dendrimer-based nanotechnology carriers for targeted drug delivery
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Dendrimer-based nanotechnology carriers for targeted drug delivery The right drug, to the right place, at the right time PowerPoint PPT Presentation


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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 time

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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 deliveryThe right drug,to the right place, at the right time

Deborah Ladenheim, PhD

Vice President, Regulatory Affairs

Avidimer Therapeutics

www.avidimer.com


Overview

Overview

  • Requirements for targeted therapeutics

  • Use of AvidimersTM for drug delivery & tumor detection

  • Benefits of targeting with AvidimersTM

  • General regulatory considerations


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

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


Dendrimer platform

Dendrimer platform

Interior Void

Dendrimer

dendri (treelike branching) + meros (a part);

~5nm

Core

Generation Number

Surface Groups


Dendrimer size comparison

Dendrimer Size Comparison


Making an avidimer tm

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


Computer model of a tri functional avidimer tm

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)


The value of avidimers tm for drug delivery

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


General regulatory considerations for nanotechnology

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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