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SWEDISH-AMERICAN LIFE SCIENCE SUMMIT August 19-21, 2009
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An Introduction to Affibody Corporate Background Privately held (HealthCap 43%, Investor 25%) Founded in 1998 by scientists from KTH and KI Based in Stockholm, Sweden 25 FTEs Technology Platforms Affibody® platform - high affinity binders Albumod TM platform - extending the half life of biotherapeutics Business Model Balanced business model generating SEK 28m (~USD 3.5m) in revenue 2008 10 deals with partners such as GE, Merck, Biovitrum, and Finnzymes 4 industrial products marketed by partners Second generation antibody mimetics company
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N N Affibody ® Technology – Proprietary Triple Helical Platforms Affibody ® Platform Albumod TM Platform 5 kDa6 kDa Two proprietary platforms – versatile business model
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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 Monoclonal Antibody (mAb) Monoclonal antibodies are reshaping the industry Therapeutic mAbs
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Affibody ® molecule 6 kDa Monoclonal Antibody (mAb) 150 kDa Affibody ® Molecules – Next Generation Antibody A fraction of the size packed with the same power 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)
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Anti-HER2 Affibody ® Molecule vs. Trastuzumab When you can see it you can treat it mAb High background Extended exposure of non-target organs 6 h p.i. 124 I-Trastuzumab, N87 Xenografted mice 124 I-Anti-HER2 Affibody® Molecule, N87 Xenografted mice 24 h p.i. Affibody ® Molecule Rapid high tumor uptake Improved potency / side- effect ratio
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N N Affibody ® Technology – Proprietary Triple Helical Platforms Affibody ® Platform Albumod TM Platform 5 kDa6 kDa Two proprietary platforms – versatile business model
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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) Half-life: from hours to days increased potency
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Therapeutics and Imaging Portfolio Overview ProgramPreclinical Research Anti-HER2 Affibody® Molecule Clinical Development Target Selection Lead Identification Lead Optimization Preclinical Breast Cancer, Phase I/IIa study approved, exploratory clinical data Bladder Cancer, Phase I study approved Breast and Bladder Cancer, pre-clinical efficacy Phase I Phase II Phase III Therapeutics Imaging Oncology Anti-EGFR Affibody® Molecule Head and Neck Cancer, ready for development Anti-PDGFRβ Affibody® Molecule Anti-PSMA Affibody® Molecule Cancer, ready for development Prostate Cancer Inflammation and autoimmune Undisclosed Hematology Long-acting G-CSF Neutropenia,PK data
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HER2 Program (Imaging and Therapy)
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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
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Orlova, A., et al. (2007) Cancer Research, 67: 2178-86. HER2 Imaging – Novel Diagnostic Applications Use cases demonstrated not possible with current standard (biopsy) CORONALTRANSVERSAL Global HER2 status (2 h p.i., PET/CT) Tumor 17-AAG treated Monitoring therapy response (4 h p.i., SPECT)
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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
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Saline Toxin fusion 250 g/kg Tumor volume BT474 Xenografts PE38 toxin Anti-HER2 Affibody ® Molecule – Payload Therapeutics Therapeutic Efficacy - HER2 Affibody ® Toxin Fusion Protein HER2 Affibody ® Toxin Fusion shrinks solid tumors
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Long-acting G-CSF (Therapy)
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Long-acting G-CSF – A Biosuperior Opportunity A single i.v. injection of equimolar amounts of G-CSF-ABD0 fusion (n=5) or G-CSF (Neupogen®) (n=2) to rats 10-Fold Increased Circulation Time Retained Specific Activity 10x increased circulation time and fully retained activity NFS-60 proliferation assay
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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
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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
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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
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