www.m4.de

The Munich Biotech Cluster m4 Approach

towards Personalized Medicine"

Horst Domdey BioM

www.m4.de

BioM – Partner for Sustainable Innovation

• Scouting & Incubation • Start-up Consulting • Funding

Academia

Big Pharma

• Partnering

• Seminars & Workshops

• Networking

• Events

SME • Funding

• Partnering

• Business Development

• Networking

• Professional Training

• Events

www.bio-m.org

www.m4.de

The Munich Life Science Cluster

- a Leading Pharma and Biotech Location

CLUSTER-MANAGEMENT

• > 250 life science companies (126 SMEs)

• > 50% of SMEs focus on Tx & Dx

• impressive drug development pipe line

• innovative platform technologies: imaging, genomics, proteomics, kinomics, etc.

• 8 excellent research institutions

• high density in hospitals, study centers

• 27 pharma companies

• 50 CROs

• 30,000 employees in the life sciences and the life science industry (SMEs: 2,850)

• > € 3 bn invested since1996

www.m4.de

0 10 20 30 40 50 60

Preclinic

Phase I

Phase II

Phase III

Market

59

33

36

8

5

Number of Clinical Candidates of Biotech SMEs in the Greater Munich Area,

BioM 2010

Munich‘s Drug Development Pipeline

www.m4.de

Cluster

Management

for Munich

Hospitals

in Munich

Biotech

and Pharma

in Munich

Science

in Munich

4 Strong Partners for Munich

€ 100 mn

Program

on

Personalized

Medicine

www.m4.de

Structure of the m4 Program R

&D

Pro

ject

s

Stru

ctural P

rojects

SP1 – m4 Trial

Service Center

SP2 – m4

Biobank Alliance

SP3 – m4 Data

Integration System

SP4 – m4 Scouting

& Incubation

SP5 – m4

eAcademy

Board

Steering Committee

Representatives from

Academia & Industry

m4-Clustermanagement

BioM

Personalized Medicine

Targeted Therapies

Preclinical

Models

Production Processes

Associated Partners

Academia & Industry

www.m4.de

Clinical Trials Phases I - III Pre Clinic Approval

eAcademy

Master of Translational Science

Executive MBA of Life Science Management

Scouting &

Incubation

special award, scouts,

targeted identification,

active incubation

Biobank Alliance

central access,

legal and ethical harmonization

highest quality standards

Trial Service Center

service and advice

phase I unit

platform service

Data Integration System

information integration

web portal

safety concept

Human Biomaterial Consulting, Recruiting

Transfer of Information

Innovation Human Capital

m4 Strategy: Establishing a Sustainable Infrastructure through Structural Projects

Translational Seed Fund: seed financing opportunities in PM (in progress)

www.m4.de

m4 Scouting & Incubation

• m4 Scouting

Identification of (bio)pharmaceutical research

projects with a high innovationspotential

• m4 Mentor Circle

Professional mentoring by retired experts from

academia and industry

• m4 Award

Regional pre-seed program for innovative

research projects in the field of biomarkers

and drug development

• m4 Incubation

Assisted incubation of the m4 Award projects

www.m4.de

m4 Award

• Bavarian pre-seed program for Personalized Medicine: € 8.5 Mio until 2015

• € 500,000 per project over 2 years; additional € 30,000 for coaching and special advice

• 80 short proposals received until 31st January, 2011

• 28 full length proposals received unti 30th April, 2011

•m4 Award Committee: experts from Biotech, Pharma and Venture Capital

• 5 grants awarded on 18th July, 2011

www.m4.de

Winners of the First Round of the m4 Award

• K-P Hopfner, F Oduncu, G H Fey (LMU):

Triplebodies against AML

• D. Schendel, C Geiger, M Javorović (HMGU):

Individualised Dendritic Cells as Vaccines for

Patients with Hormone-resistant Prostate Cancer

• M Conrad, J A Schick (HMGU):

New Drugs for the Treatment of

Neurodegenerative Diseases

• F Hausch, M Paez-Pereda (MPI Psychiatry):

Development of FKBP51 Specific Molecules

to Treat Depression

• O Ritter (Univ. Würzburg):

Calportin as First Line Treatment of Heart Failure

www.m4.de

m4 Strategy (II): Boosting Innovation through

40 R&D Projects (mostly Cooperations)

Biomarker

Identification & Validation

Companion Diagnostic

Feasibility and Benefit Market

Drug Development Clinical Trials Phase I - III Market Approval

Approval

Value Chain of Personalized Medicine

Preclinic

Validated

Test Kit

Biotech SME

Pharma/Medtech

Industry

Academia / Clinics

PM6

PM10 PM12

PM13

PM 16 PM15

T4

PM1

PM 7

PM 8

PM 17

PM 2

PM9

PM4

PM5

PM 14

T5

T10

T2

T3

T6

T12 T14

T15 T16

P2

P3

PK1

T9

T17

Focus on:

-> new targeted therapeutics

-> innovative therapy concepts

-> identification and validation of biomarkers

by molecular diagnostics and imaging

techniques

-> set up of platform technologies

main indications: oncology, cardiovascular

diseases, chronic lung diseases, autoimmune

diseases and inflammation

www.m4.de

COR-1, a new Drug for the Treatment

of a Severe Form of Heart Failure

COR-1 is a cyclic peptide

which neutralizes

stimulatory autoimmune

antibodies directed against

the beta-adrenergic receptor

mimicking the effect of

natural ligands like

adrenaline and thus leading

to a chronic over-stimulation

of the receptor.

Consequently this leads to

hypertrophy and reduced

function of the heart.

• Ex vivo, COR-1 showed good

efficacy to neutralize anti ß1

receptor autoantibodies.

• In animal models, COR-1

prevented the generation of heart

failure and also reversed existing

heart failure.

• In a placebo-controlled phase

I clinical trial COR-1 was shown

to be well tolerated.

• COR-1 is now being investigated

in a phase II clinical trial; it is

administered to a subgroup of

heart failure patients who have

been stratified by a specific

diagnostic test.

COR-1 – an m4 Lighthouse Project by Corimmun

www.m4.de

m4 – Evolution through Innovation

2010 1996 1984 2020

Winner in the

BioRegio Contest

Munich

Gene Center

Winner in the

Leading Edge Cluster

Competition

m4

International Cluster of Excellence

in Personalized Medicine

www.m4.de

Predictive Biomarkers

- DNA/RNA-omics

- Proteomics

P4 Medicine – Healthcare of the Future

Personalized Stratification of Patients

- Herceptin

- Erbitux

- . . .

Preventive Life Style and Treatment

- Phenylketonuria

- Diabetes

- Cancer

Participatory Informed Decisions

by informed Patients

- 1000$ Genome