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Protagen AG
Otto-Hahn-Str. 15
D-44227 Dortmund
www.protagen.com
The AutoImmuneDx Company
CONFIDENTIAL
European Business Development Conference Düsseldorf , September 2013
- 2 - CONFIDENTIAL
PROTAGEN Introduction & SeroTag® Autoantibody Profiling
PROTAGEN Experience, Expertise & Product Portfolio
Case Study : Response Prediction in early RA
Investment Case
1
2
3
4
Agenda
Protagen AG – Key Facts
-3-
Human Protein Library
Protagen HQ, Germany
1000 m² lab facilities
Set-up:
Experienced management team
ISO 9001/2008 certified
Expertise
Unique, exploratory SeroTag® approach
for Dx/CDx development
Focus on autoimmune diseases
Excellent IP position
Financial status
Privately held
Committed, long-standing investors
CONFIDENTIAL
Biggest Expression
Library
High Throughput
Measurement
Leading
Analysis
Team
Impeccable
Quality
The SeroTag® - Process: Success Factors
Unique, fully integrated,
exploratory Approach
One of biggest protein libraries
Established high throughput
technology - Luminex®
Industry Leading Biostatistical
Analysis Team
Marker developed in parallel to
compound – We won’t fail you!
Applicable to Dx & CDx
development
-4- CONFIDENTIAL
-5-
SeroTag® technology employs autoantibodies as biomarkers
CONFIDENTIAL
hPEX®
Antigen Expression Library
• 180,000 clones
• 14,000 genes
• >7,000 proteins
SeroTag®
Bead-Based Arrays
• Multiplex analysis of up to 500 proteins in 1 bead set
Data Mining & Statistics
• Single markers and combinations of markers
• Criteria: AUC, p-value, sensitivity, specificity
SeroTag® - The Technology
Business Model
- 6 - CONFIDENTIAL
hPEX® & SeroTag®
Technology
SLE
IVD
RA AID
Value
Generation
IP Data
$
New Indications CDx
2017 +
SLE AID
Pharma
Collaborations
MS RA
IP Data
New Indications
- 7 - CONFIDENTIAL
PROTAGEN Introduction & SeroTag® Autoantibody Profiling
PROTAGEN Experience, Expertise & Product Portfolio
Case Study : Response Prediction in early RA
Investment Case
1
2
3
4
Agenda
Drug Development for Autoimmune Therapy
An endeavour with many challenges
-8- CONFIDENTIAL
Sales of 9.3 billion US$ in 2012
Average non-responder rate in Autoimmune Disease Drug Therapy ~ 50%
PROTAGEN
Increases your chances!
Experience & Expertise
Core Area: Rheumatology & Immunology
-9-
RA; 75 SLE;
130
Healthy; 250
Early Arthritis;
751
PSS; 100
AS; 82
Early RA Humira/
MTX Study;
349
Why Immunology/
Autoimmune-Diseases?
Area of high unmet medical
need
Often lack of stratification
biomarkers for new medicines
Autoantibodies well established
in most indications
Broad IP base on markers,
autoantigens and autoantibodies
Own Dx/CDx development
CONFIDENTIAL
RA in vitro Diagnostic Assays – Current Status
- 10 - CONFIDENTIAL
• Established IVD market in RA
• With room for improvement of sensitivity
• And a clear need for additional IVDs, in particular for seronegative
patients
RF IgM RF IgA Anti- CCP2 Anti- MCV
RA sensitivity 60-80% 44% 39-94% 69.5-82%
RA specificity 80-95% 84% 81-100% 90.3-98%
Early RA sensitivity 15-30% 29-39% 25-58% 57-71%
Disease activity correlation ? yes no yes
Correlation to outcome yes yes yes Yes
Association to extra-cellular
manifestation yes yes yes unkonwn
RF: rheumatoid factor
Egerer et al; 2009 (Dtsch. Ärzteblatt)
PROTAGEN Market Overview
- 11 -
Market
Importance
Market Size
≈
≈
- 12 - CONFIDENTIAL
PROTAGEN Introduction & SeroTag® Autoantibody Profiling
PROTAGEN Experience, Expertise & Product Portfolio
Case Study : Response Prediction in early RA
Investment Case
1
2
3
4
Agenda
Disease
Average % of
non-
Responders
Author Citation
Rheumatoid Arthritis (ACR20) 28 - 58 Craig Beavers et al.Orthopedics
January 2010 - Volume 33 · Issue 1
Ankylosing spondylitis (ASAS
20)40 C McLeod et al. Health Technol Assess 2007;11:1–158
Psoriatic Arthritis (MEASE
2004, 24weeks, PsARC and
ARC50)
30 - 63 M Rodgers et. All Health Technology Assessment 2011; Vol. 15: No. 10, p.19
SLE (EULAR 2009) 45 Merrill EULAR 2009, Benlysta, BLISS 52 and 76
Lupus Nephritis 44 - 47 G. Apple JAm Soc Nephrol 2009, Cellcept vs. Cyclophosphamide
Multiple Sclerosis 50Communication of DMSG on
Fingolimod
http://www.dmsg.de/multiple-sklerose-
news/index.php?w3pid=news&kategorie=therapien&anr=
2310
Crohn's Disease - Primary non
responders to anti TNF-alpha30 - 40 Remo Panaccione, MD, FRCPC
Advanced Therapy of Inflammatory Bowel Disease,
Volume 2: IBD and Crohn's ... von Theodore
Bayless,Stephen B Hanauer
Crohn's Disease - Secondary
non responders to anti TNF-
alpha
30 - 40 Remo Panaccione, MD, FRCPC http://www.medscape.org/viewarticle/578444_3
Ulcerative Colitis 41 - 50 Walter Reinisch et. al. Gut 2011;60:780e787, Results of NCT00385736
Epilepsy (Lacosamide) 59 - 67 E Ben-Menachem Epilepsia 2007; 48 (7): 1308-17
Epilepsy (Zonisamide) 50 MJ Brodie Epilepsia 2005; 46(1):31-41
Parkinson's Disease
(Rotigotine)52 RL Watts et al. Neurology. 2007;68(4):272
Prevalence of non-Responders in AID Therapy
-13- CONFIDENTIAL
- 14 - CONFIDENTIAL
Response Prediction- The Million Dollar Question
Case Study: Adalimumab & MTX in early RA
- 15 -
MTX monotherapy Early RA
<1 year
T0 T48 T24
Adalimumab + MTX
Placebo + MTX
3a
3b
3c
1
Diagnosis Predicting
Remission
CONFIDENTIAL
2
Monitoring
Treatment
What have we done?
Protagen looked into a better diagnosis of patients (1), monitored treatment effects
(2) and investigated the possibility to predict remission (3)
Remission prediction and Non-Remission prediction marker were found by the
retrospective analysis of T0 (before first dosing) sera from early RA patients
Clinical endpoint results (DAS28) from T24 were available at time of analysis
Distinct markers predicting remission but also predicting non-remission for Humira
(3a), MTX (3c) and Humira/MTX (3b) were found
SeroTag® provides access to treatment specific response prediction
markers!
1
2 3
3a 3b 3c
CONFIDENTIAL - 16 -
Reactivity in
ADA/MTX Non-
Remission Group
Reactivity in
ADA/MTX
Remission Group
Distinct sets of autoantigens were identified for patients achieving/not achieving
remission at T24 by analyzing T0 samples!
Predicting Remission for Adalimumab and MTX A
ntigens
- 17 - CONFIDENTIAL
PROTAGEN Introduction & SeroTag® Autoantibody Profiling
PROTAGEN Experience, Expertise & Product Portfolio
Case Study : Response Prediction in early RA
Investment Case
1
2
3
4
Agenda
Business Model
- 18 - CONFIDENTIAL
hPEX® & SeroTag®
Technology
SLE
IVD
RA AID
Value
Generation
IP Data
$
New Indications CDx
2017 +
SLE AID
Pharma
Collaborations
MS RA
IP Data
New Indications
CONFIDENTIAL -19-
Product Development Pipeline
Candidate Product
Indentifier Discovery Validation
Assay
Development
Prototype
Assay
Market
Launch
RA Dx CCPbetter & CCP-
Q4/2013 Q3/2014 Q1/2015
RA MTXpred CDx Q1/2014 Q4/2014 Q2/2015
RA TNFpred CDx Q2/2014 Q1/2015 Q3/2015
SLE Dx & CDx Q2/2014 Q3/2014 Q2/2015 Q4/2015
SSC Dx IVD & Prognosis
Q4/2013 Q2/2014 Q4/2014
AS Dx Q1/2014 Q2/2014 Q4/2014 Q2/2015
NMO Dx Q2/2014 Q1/2015 Q3/2015
Novel IVD Products for unmet diagnostic needs
Pharma Collaboration Market Potential
More than 2.000 Projects running today, attractive market
potential for Protagen
Active clinical trials which can profit from SeroTag®
Rheumatoid Arthritis
Lupus
IBD Multiple
Sclerosis
Thyroid Disease and
Endometriosis
Cancer Vaccines
~450
~470
~320
~350
~160
~270
CONFIDENTIAL - 20 -
Executive Summary
-21-
PROTAGEN AG
Privately owned, located in Dortmund, Germany
31 employees, VC-backed
Unique platform for novel IVD Products
Access to proprietary biomarkers for Dx and CDx
Blood serum-based technology – small samples, stable analytes
Strong pipeline in Autoimmune Diseases
Development of own IVD Test – market access 2015
Pharma Collaborations to generate revenue stream
Strategic Partnership with PAREXEL (CRO)
SeroTag® supports Drug Development in all Clinical Development Phases
Retention of Diagnostic Commercialization Rights, strong IP position
Unique position in stratified therapies and personalized medicine
CONFIDENTIAL
- 22 -
Protagen AG
Otto-Hahn-Str. 15
44227 Dortmund
Germany
T + 49 231 9742 6300
F + 49 231 9742 6301
bd@protagen.com
www.protagen.com
CONFIDENTIAL
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