Methylome against cancersFrom innovation to a key business case

December 8th, 2010

Dr. Sandra HUYGEN, PhD, MBA

Innovative Molecular Diagnostics Value Chain

PCR Methylation Oncology Diagnosis Personnalized med.

OutcomeObjectivesResources TechnologyInstrumentation

18 proves of concept IP rights on >300 biomarkers

and Companion Dx Outlicencing to Selfscreen Commercial deal with GSK-Bio Sample collection Publications (in prep.)

Partners

Budget - 3.739.054 €

Manpower - 20 FTEs

3.5 Y Dec 2010

2

July 2007

3

How does it work?

4

PEOPLE

SYNERGY

INNOVATION

Business model

S. O.

Commerc.

Key factors

5

People

Synergies

MDxHealth

GSK-BioULg - Patho

Leading vaccine manufacturer

Antigen Specific Cancer Immunotherapies

development

MSP technologyPatented gene portfolio

Academic advisorsCommercial channels

Leading Europeangynecological cancer expertise Stored and prospective clinical

samples

Leading European cancer

expertise in particular in

cervical oncology and HPV

field

ULg - Gyneco

Innovation

Methylation Specific PCR (MSP) Technology

Methylation present in all cancersMethylation regulates gene expression

Specific genes methylated in each cancerAbnormal methylation of specific genes is correlatedwith cancer development

Sensitive detection in all sample typesDetects 1 cancer cell among 10,000 normal cells

One or few genes suffice for testsNo complicated algorithms, etc.

Technology runs on any PCREquipment already installed worldwide

Straight-forward testingAutomatable

Patented TechnologyBoth detection technology and individual genes (biomarkers)

Strategy & Business model

Commercial partners

Diagnostic & pharma companies

Service lab US: CLIA lab

Service lab Wallonia

Development

& test Clinical Trials & FDA

Approval

MassMarket Kit

Sales

Commercialization:

Service Lab Sales

Kit Dev. Kits sales

Service

Lab Dev.Prototype

definitionBiomarker

discoveryReg.

Review

Lab Service sales

Basic research Applied research Commercialization

OncoMethylomic project

Academic partnerships

MSP technology

Prototype

development

Clinical

verification

Structures - Organisation - Strategies (SOS)

Organization,

Project management,

Partner rights & obligations

IP,

Access rights,

Publications,

Confidentiality,

Royalties & Fees

Legal framework

Consortium agreement Clinical Research

Agreements

Steering committee

Business development

Valorization committee

Executive committee

Task forces

BioWin RW – DGO6

Consortium organization

R&D – Technical review

Regulatory AffairsMarketing- BD

Clinical Affairs

Design control

QA

IP

13

Conclusion

Creates a culture of openness and

partnership favorable to innovation

14

For further information

Sandra HUYGEN

Sandra.huygen@AllianSes.bewww.AllianSes.be

Mobile: 0032/486.467.191