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SWEDISH-AMERICAN LIFE SCIENCE SUMMIT August 19-21, 2009. An Introduction to Affibody. Second generation antibody mimetics company. Affibody ® Technology – Proprietary Triple Helical Platforms. Affibody ® Platform. Albumod TM Platform. N. N. 6 kDa . 5 kDa .

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an introduction to affibody
An Introduction to Affibody

Second generation antibody mimetics company

affibody technology proprietary triple helical platforms
Affibody® Technology – Proprietary Triple Helical Platforms

Affibody® Platform

AlbumodTM Platform

N

N

6 kDa

5 kDa

Two proprietary platforms – versatile business model

the antibody opportunity
More than 20 approved therapeutic mAbs

Blockbusters such as Rituxan®, Remicade®, Herceptin®, Avastin®, Humira®, Erbitux®, and Synagis®

Therapeutic mAb revenue projected at above USD 30bn in ’09

Expected 5-yr Sales CAGR >10%

Large pipeline of products in late-stage development

The Antibody Opportunity

Monoclonal Antibody (mAb)

Therapeutic mAbs

Monoclonal antibodies are reshaping the industry

slide5

Affibody® Molecules – Next Generation Antibody

  • Small size (1/25th the size of a mAb)
  • High selectivity and affinity (high potency)
  • Rapid and reversibly folding (extreme stability)
  • Flexible low cost production (peptide synthesis or recombinant production)
  • Flexible engineering and formatting (modified properties and formats)

Affibody® molecule6 kDa

Monoclonal Antibody (mAb)150 kDa

A fraction of the size packed with the same power

anti her2 affibody molecule vs trastuzumab

6 h p.i.

24 h p.i.

6 h p.i.

24 h p.i.

Anti-HER2 Affibody® Molecule vs. Trastuzumab

124I-Trastuzumab, N87 Xenografted mice

mAb

  • High background
  • Extended exposure of non-target organs

124I-Anti-HER2 Affibody® Molecule, N87 Xenografted mice

Affibody® Molecule

  • Rapid high tumor uptake
  • Improved potency / side-effect ratio

When you can see it you can treat it

affibody technology proprietary triple helical platforms7
Affibody® Technology – Proprietary Triple Helical Platforms

Affibody® Platform

AlbumodTM Platform

N

N

6 kDa

5 kDa

Two proprietary platforms – versatile business model

albumod tm platform extending half life
Potency – sustained efficacy

Economy – reduced dosage

Safety – avoid high peak blood concentrations

Life cycle management / Biosuperiors

Half Life from Minutes to Days (primate)

5-fold Higher Dose on Tumor (mouse)

AlbumodTM Platform – Extending Half-Life

Half-life: from hours to days  increased potency

therapeutics and imaging portfolio overview
Therapeutics and Imaging Portfolio Overview

Clinical Development

Program

Preclinical Research

TargetSelection

LeadIdentification

Phase I

LeadOptimization

Phase II

Preclinical

Phase III

Oncology

Anti-HER2Affibody® Molecule

Breast Cancer, Phase I/IIa study approved, exploratory clinical data

Bladder Cancer, Phase I study approved

Breast and Bladder Cancer, pre-clinical efficacy

Anti-EGFRAffibody® Molecule

Head and Neck Cancer, ready for development

Anti-PDGFRβAffibody® Molecule

Cancer, ready for development

Anti-PSMAAffibody® Molecule

Prostate Cancer

Hematology

Long-acting G-CSF

Neutropenia,PK data

Inflammation and autoimmune

Therapeutics

Imaging

Undisclosed

Undisclosed

anti her2 affibody molecule imaging opportunity
Anti-HER2 Affibody® Molecule Imaging Opportunity

Breast Cancer

  • Exploratory clinical data available
  • Phase I dose finding study approved

Bladder Cancer Imaging

  • Exploratory application approved

Safety and Immunology

  • Repeated dose tox demonstrated the molecule to be safe and well tolerated
  • Non-immunogenic after repeated dosing in rat

Clinical Development Plan

  • Phase I dose finding study (27 patients, 6 months)
  • Phase III confirmatory study (150-200 patients, 9 months)

Breast Cancer patient with brain metastasis

Short time to market – limited number of patients

her2 imaging novel diagnostic applications

Tumor

Tumor

17-AAGtreated

CORONAL

TRANSVERSAL

HER2 Imaging – Novel Diagnostic Applications

Global HER2 status (2 h p.i., PET/CT)

Monitoring therapy response (4 h p.i., SPECT)

Orlova, A., et al. (2007) Cancer Research, 67: 2178-86.

Use cases demonstrated not possible with current standard (biopsy)

trends in oncology mab therapy
Trends in Oncology mAb Therapy
  • Antibody-drug conjugation (payloads)
    • T-DM1 (Herceptin + payload), Ph III, Genentech/ImmunoGen
      • Genentech plans to file 1-2 INDs on payload drugs annually
    • SGN-35 (CD30 + payload), Ph III, Seattle Genetics
  • Focus on effector functions
    • e.g. Xencor, Macrogenics, Glycart, Micromet – BiTE, Merrimack – HER2/HER3

The Affibody® molecule is an optimal payload carrier

anti her2 affibody molecule payload therapeutics

PE38 toxin

Anti-HER2 Affibody® Molecule – Payload Therapeutics

Therapeutic Efficacy - HER2 Affibody® Toxin Fusion Protein

Tumor volume

BT474 Xenografts

Saline

Toxin fusion

250 g/kg

HER2 Affibody® Toxin Fusion shrinks solid tumors

long acting g csf a biosuperior opportunity

NFS-60 proliferation assay

Long-acting G-CSF – A Biosuperior Opportunity

Retained Specific Activity

10-Fold Increased Circulation Time

A single i.v. injection of equimolar amounts of G-CSF-ABD0 fusion (n=5) or G-CSF (Neupogen®) (n=2) to rats

10x increased circulation time and fully retained activity

achievements during 2009
Achievements During 2009
  • Therapeutics
    • Preclinical efficacy demonstrated in collaboration with NCI (HER2)
    • Prolonged circulation time with retained activity demonstrated (G-CSF)
  • Medical Imaging
    • Approved Swedish Bladder Cancer Imaging Study
    • Approved German Breast Cancer Imaging Study
  • Business Development
    • Collaboration with Biovitrum
    • New deals currently negotiated

Considerable achievements during 2009

the value of antibody mimetics example of deals
The Value of Antibody Mimetics – Example of Deals

Amgen acquired Avidia for $290m (2006)

  • Amgen bought Avidia to get access to a small scaffold protein, based on only early preclinical data.

Pfizer bought BioRexis for an unknown amount (2006)

  • The acquisition gave Pfizer proprietary rights to transferin as a scaffold, and for halflife extension of peptides. Only preclinical data were available at the time of purchase.

GSK acquired Domantis for $455m (2006)

  • Domantis was a domain antibody scaffold company. Only preclinical data were available at the time of purchase.

BMS bought Adnexus for $430 million (2007)

  • Adnexus had proprietary rights to fibronectin as a scaffold, and for halflife extension of peptides. Only preclinical data were available at the time of purchase.

Significant values have been realized by similar technologies

investment case
Investment Case
  • Balanced portfolio – therapeutics and diagnostics
    • From imaging to therapy in oncology
    • Excellent payload carrier
  • Growing revenue stream
    • Primarily driven by royalty revenue
  • Validating collaborations

Positioned to capitalize on the next wave of antibody therapeutics