Transcript Affibody Presentation

SWEDISH-AMERICAN LIFE SCIENCE SUMMIT
August 19-21, 2009
An Introduction to Affibody
 Privately held (HealthCap 43%, Investor 25%)
Corporate
Background
 Founded in 1998 by scientists from KTH and KI
 Based in Stockholm, Sweden
 25 FTEs
Technology Platforms
 Affibody® platform - high affinity binders
 AlbumodTM 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
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
Monoclonal Antibody (mAb)
Therapeutic mAbs
 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 antibodies are reshaping the industry
Affibody® Molecules – Next Generation Antibody
Monoclonal Antibody (mAb)
Affibody® molecule
150 kDa
6 kDa

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)
A fraction of the size packed with the same power
Anti-HER2 Affibody® Molecule vs. Trastuzumab
124I-Trastuzumab,
N87 Xenografted mice
mAb
 High background
 Extended exposure of
non-target organs
6 h p.i.
124I-Anti-HER2
24 h p.i.
Affibody® Molecule, N87 Xenografted mice
Affibody® Molecule
 Rapid high tumor uptake
 Improved potency / sideeffect ratio
6 h p.i.
24 h p.i.
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
AlbumodTM Platform – Extending Half-Life

Potency – sustained efficacy

Economy – reduced dosage

Safety – avoid high peak blood
concentrations
Half Life from Minutes to Days (primate)
5-fold Higher Dose on Tumor (mouse)

Life cycle management / Biosuperiors
Half-life: from hours to days  increased potency
Therapeutics and Imaging Portfolio Overview
Program
Clinical Development
Preclinical Research
Target
Selection
Lead
Identification
Lead
Optimization
Preclinical
Phase I
Phase II
Phase III
Oncology
Breast Cancer, Phase I/IIa study approved, exploratory clinical data
Anti-HER2
Affibody® Molecule
Bladder Cancer, Phase I study approved
Breast and Bladder Cancer, pre-clinical efficacy
Anti-EGFR
Affibody® Molecule
Head and Neck Cancer, ready for development
Anti-PDGFRβ
Affibody® Molecule
Cancer, ready for development
Anti-PSMA
Affibody® Molecule
Prostate Cancer
Hematology
Long-acting G-CSF
Neutropenia,PK data
Inflammation and
autoimmune
Undisclosed
Therapeutics
Undisclosed
Imaging
HER2 Program
(Imaging and Therapy)
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)
Short time to market – limited number of patients
Breast Cancer patient
with brain metastasis
HER2 Imaging – Novel Diagnostic Applications
Global HER2 status (2 h p.i., PET/CT)
Monitoring therapy response (4 h p.i., SPECT)
Tumor
Tumor
17-AAG
treated
CORONAL
TRANSVERSAL
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
Anti-HER2 Affibody® Molecule – Payload Therapeutics
Therapeutic Efficacy - HER2 Affibody® Toxin Fusion Protein
1200
1000
tumor volume, mm
3
Tumor volume
800
Saline
BT474 Xenografts
600
PE38 toxin
400
200
Toxin fusion
0
0
5
10
15
20
25
30
35
40
days
HER2 Affibody® Toxin Fusion shrinks solid tumors
250 g/kg
Long-acting G-CSF
(Therapy)
Long-acting G-CSF – A Biosuperior Opportunity
Retained Specific Activity
10-Fold Increased Circulation Time
1600
G-CSF-ABD035
1400
G-CSF
NFS-60 proliferation assay
1200
Proliferation (OD 450)
Concentration (nM)
2,5
1000
800
600
400
200
0
Standard (Neupo gen)
2,0
G-CSF A lbumo d
1,5
1,0
0,5
0,0
0
20
40
60
Time (h)
80
100
120
1
10
100
Concentration (pg/ml)
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
1000
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