Personalized Medicine M4

1. www.m4.de
Munich Biotech Cluster m4
–
m4 – Personalized Medicine and Targeted Therapies
BioM Biotech Cluster Development GmbH

2. www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine”
• m4 R&D projects
• m4 structural projects

3. www.m4.de
1989 Munich’s first biotech company is founded
1996 Munich is awarded in the BioRegio Competition of the
BMBF(DM 50 mio.)
1997 BioM ist founded as a central point of contact for the Greater
Munich Area
2007 Munich is awarded in the BioIndustry 2021 Competition
(industrial biotechnology) of the BMBF (€ 5 mio.)
2010 Munich is awarded in the Leading-Edge Cluster Competition
of the BMBF(€ 40 Mio.)
2013 Today about 260 Life Science companies
30.000 employees in industry and science
History of the Munich Biotech Cluster
www.bio-m.org

4. www.m4.de
BioM – cluster management since 1996
• Scouting & Incubation
• Consulting for start-ups
• Consulting about funding
Academia
Big Pharma
• Partnering
• Seminars & workshops
• Networking
• Events
SME
• Consulting about funding
• Partnering
• Business development
• Networking
• Vocational training
• Events
www.bio-m.org

5. www.m4.de
Mission of BioM
BioM is the central point of contact for
biotechnology in Munich and Bavaria.
The major goal of BioM is to foster the
development of the Munich & Bavarian
Biotech Cluster and promote it as one of
the leading life science clusters in Europe.
www.bio-m.org

6. www.m4.de
Source: IZB
Location of BioM
Campus Martinsried-Großhadern

7. www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine”
• m4 R&D projects
• m4 structural projects

8. www.m4.de
The Munich Biotech Cluster m4 is a SME cluster
129
26
53
29 25
Biotech Small
and Medium
Companies
(SMEs)
Biotech
Companies (non-
SMEs)
Contract
Research
Organisations
(CROs)
Pharma
companies
Unternehmen
Others
Number of Biotech Companies
in the Greater Munich Area,
BioM 2010
0 20 40 60 80
1-10 Mitarbeiter
11-50 Mitarbeiter
51-100 Mitarbeiter
101-250 Mitarbeiter
Per cent
employees
employees
employees
employees

9. www.m4.de
The Munich Biotech Cluster m4 is a TxDx Cluster
0
10
20
30
40
50
60
70
Fields of Activity of Munich’s Biotech SME,
in %, BioM 2010

10. www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine”
• m4 R&D projects
• m4 structural projects

11. www.m4.de
Leading-Edge Cluster Competition 2010
€ 40 mio. funding from BMBF
< € 40 mio. from industy
< € 10 Mio. from state of Bavaria
 About € 100 mio. for
Personalized Medicine in the
next 5 years
35 R&D projects
5 Structural projects
Fostering of collaborations between
small and medium-sized entreprises,
large companies and academia.
www.m4.de

12. www.m4.de
m4 – Partners for innovation and develoment

13. www.m4.de
Personalized medicine takes into account therapy-
relevant differences between patient groups

14. www.m4.de
Personalized medicine increases the efficacy of drugs
• 90% of all drugs are efficeint in only 30-60 % of the patient population
The Case for Personalized Medicine, 2011.

15. www.m4.de
• 800 mio. US-$ per new therpeutic
• Time-to-market 10-15 years and attrition rates of 90%
• Attition rates cause a yearly loss of about 300 mio. US-$
Phase III and submission failures, n=83
Nature Rev Drug Discov 10: 87 ( 2011 )
• Deficient efficacy (66%) and safety (21%) are main reasons for
attritions
Personalized medicine increases the efficiency of
drug development

16. www.m4.de
A new Dimension in Drug Development
Symptom Based Medical Treatments
• „one fits all“ / blockbuster approach
• limited efficacy (only 40-60%)
• high rate of unwanted side effects
• high number of failures
• long development times
• high costs for drug development
Personalized Medicine
• tailored for patient (sub)populations
• more effective drugs
• safer drugs
• lower failure rates
• up to10 x smaller clinical trials
• lower costs for clinical trials
classical
diagnosis
classical diagnosis
+ biomarker tests

17. www.m4.de
Patient history
Familiy diseases
Age, sex,…
Psyche, Compliance
Personalized medicine is an integrative concept
Best therapy available
Diagnosis
Clinical parameters
Multi morbiditity
Medication
Life style
Nutrition
BMI
Prediction
Response
Dose
Prognosis
Biomarker
Genom, Epigenom, Transcriptom, Proteom, Metablom,…

18. www.m4.de
Five m4 structural projects support the valued-added
chain of personalized medicine
m4 Trial Service Center
services and consulting
phase I unit
onsulting, patient recruitingBio probes
m4 Biobank Alliance
central access, ethical and legal harmonization,
shared quality standards
informationinformation
m4 Data Integration System
information integration, web portal
m4 eAcademy
Master of Translational Science and Drug Development;
Executive MBA of Life Science
personellinnovation
m4 Scouting & Incubation
m4 Award, m4 Scouts
identification & incubation
m4 R&D
projects
research clinical Phase I - IIIpreclinic approval
clinical validation test kit certificationbiomarker identification and validation

19. www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine”
• m4 R&D projects
• m4 structural projects

20. www.m4.de
Biomarker development:
PM2: Biomarker-gestützte funktionelle Wirkstofftestung
PM6: Bestimmung von Immun- und Tumorparametern im Serum
PM7: Imaging BM für Tumoresponse
PM8: CT und MRT als Biomarker
PM13: Integrale Netwerkanaylse zur Stratifizierung
PM15: Biobank der Blutspender, Plattform für Präventivdiagnostik
PM16: Wirksamkeitsvorhersagen über Phosphosignaturen
PM20: Identifikation von Mutationen beim malignen Melanom als BM
PM21: Bildgebende LRRK2 BM bei Parkinson
PM23: KIR1.4 Antikörper als BM zu Prognose, Prädiktion und Monitoring bei MS
PM24: NGS Ansatz zur Identifizierung von BM für Schizophrenie
PM25: BM beim Adenokarzinom aus Barett Ösophagus
PM27: BM Identifizierung bei Helicobacter pylori Infektion – drug target bei Magenkrebs
Drug development – preclinical development:
PM1: Individualisierte Therapie neuroendokriner Tumore
PM4: Immunmonitoring innerhalb eines IIT mit Catumaxumab und FBTA05
PM5: Innovative Stammzellbasierte Therapie für maligne und nicht-maligne Erkrankungen
PM9: Bildgebende Verfahren zur Unterstützung der antiangiogentischen Therapie mittels eines RGD-Peptids
PM10: Herstellung von Fluor-18 markierten PET Radiotracern für die personalisierte Medizin
PM14: Reversible Streptamer Reagenzien für die klinische Zelltherapie
PM18: Präklinsche Entwicklung eines gegen c-met gerichteten Anticalins
PM19: Entwicklung eines IL-3 spezifischer Antikörpers für die Behandlung von rheumatoider Arthritis
PM26: Präklinische Entwicklung eines TLR7/8 Antagonisten für die Tumortherapie
m4 R&D cooperation projects

21. www.m4.de
New therapeutics
T2: Zyklopeptid COR-1 gegen Herzinsuffizienz – verkauft an Janssen
T3: Präklinische u. klinische Entwicklung eines PI3 Kinase Inhibitors
T4: CD38 mAb zur Behandlung hämatologischer Tumore
T5: Fc Rezeptoren zur Therapie von Autoimmunerkrankungen
T6: micro RNA basierte Therapien für kardiovaskuläre Erkrankungen
T9: Inhibitoren gegen essentielle bakterielle targets
Plat form technologies
T14: Targeting von Biotherapeutika in die Lunge
T15: „Pasylation" für optimierte Pharmakokinetik
T16: Rekombinante Spinnenseide als Biomaterialträger
T17: Strukturbasierte AK-Charakterisierung
T18: Verbesserung der Effektivität und Spezifität von RNAi Ansätzen
P2: Transgene Produktionsplattform für rekombinante Antikörper
P3: Herstellungsbereich für GLP Produktionen für präklinische Testungen
PK1: Advances Preclinical Animal Models – Großtiermodelle
m4 R&D cooperation projects
http://www.m4.de

22. www.m4.de
Example: Spherotec GmbH, LMU und MRI: Diagnostic
platform for cancer therapy decision
Cancer
patient
2nd step: Spheroid TechnologyTM
tissue
Sterile tumor sample
Selection of drugs with best
possible efficacy
biomarker profiling
 Therapy relevant
molecules
 Resistence marker
Grinding
Micro tumors In vitro therapy of micro tumors
efficacy/dose/sequence
Optimal therapy
physician
1st step: biomarker profiling
9 days
Best possible therapy for the individual patient

23. www.m4.de
Example: CD38 mAb (MOR202) as a therapy against
hematological tumors
CD38
MOR202
(Anti-CD38)
ADCC
Approved drugs
NK cell
activation
Direct
effects
Fc Receptor
antibody
Inokuliert
Kontrolle
µ-CT
Analyse der
Tibia
Inokulation der MM
Zellen in die Tiba
Multiples Myelom
Tumormodell in der Maus
AK Vermittelte Zytoloyse
Synergistic efficacy
by combination

24. www.m4.de
Translation into the clinic
 Preclinical studies
 Validation of (newly) established animal modesl
 Development of new animal models for m4 partners
Drug discovery Preclinical tests Patient
New biomarkers Applicable Models
Proof of principle Similarities in physiology/anatomy
Example: “Advanced Preclinical Animal Models”
Used in m4 projects concerning
 Cell therapy
 Respiratory diseases
 Cancer therapy
 Diabetes

25. www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine”
• m4 R&D projects
• m4 structural projects

26. www.m4.de
m4 Scouting & Incubation: support for innovation and start-
ups in the area of personalized medicine
• m4 Award
New regional competition
funding for innovative pre-seed projects
• m4 Incubation
Targeted development of the projects by
individual and professional project
management
• m4 Scouting
Targeted identification and support for
research projects with high innovation
potential
• m4 Mentor Circle
Mentoring programme for scientists
and young entrepreneurs

27. www.m4.de
m4 eAcademy – Establishment of a Master and EMBA
proramme for Life Sciences
• Custom-fit
Specialised vocational training for
managers and scientists aiming at the
challenges of personalized medicine
• Modular and extra-occupational
Flexible training
• Application-oriented and international
Curricula developed in cooperation with
industry
• Master of Translational Science and Drug Development
• Master of Business Administration Life Science

28. www.m4.de
m4 Biobank Alliance provides a central access
to high-quality bioprobes
Quality
Informed
consent
LMU Biobank i.A. HTCR
Pathology, Surgery, Clinical Chemistry
TUM Biobank
Pathology, Surgery, (Clinical Chemistry)
ethics, governance, framework
m4
Biobank
Services
Center
Central access
Central contact for
industry and
science
High, common
quality standards
Integration of further
clincal institutes
Integration of/
cooperation with
further biobanks
TransparencyEthical standards
28
Helmholtz Zentrum München

29. www.m4.de
m4 Data Integration System:
Data management and processing
• Clinical systems
Identity, diagnosis, therapy
Patient record
Follow up of clinical data
• Research systems
encrypted identity
analysis data
Follow-up of molecular data
• Inter-institutional infrastructure
• Central portal, data warehouse
• ID management, pseudonymisation, anonymisation

30. www.m4.de
m4 Trial Service Center (TSC)
• Consulting for translational research and development
• Network of experts for clinical studies
• Infrastructure & ressources for clinical studies:
 Service unit for early clinical phases
 Imaging Center
 Technology platforms
• Network of experts / clinics / service providers
• Synergy with other m4 structural projects
(m4 Biobank Alliance and m4 Data Integration System)

31. www.m4.de
• Contact
BioM Biotech Cluster Development GmbH
Am Klopferspitz 19a
82152 Martinsried
Germany
Phone: +49 (0) 89 89 96 79 - 0
Fax: +49 (0) 89 89 96 79 -79
Email: info@bio-m.org
• Web
Cluster management BioM http://www.bio-m.org
Personalized Medicine in Munich http://www.m4.de