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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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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 AlbumodTM Platform N N 6 kDa 5 kDa Two proprietary platforms – versatile business model
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
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
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 Platforms Affibody® Platform AlbumodTM Platform N N 6 kDa 5 kDa Two proprietary platforms – versatile business model
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 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 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
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 • 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
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
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 • 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 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 • 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