From ‘science in practise’ to ’science in business’

Jack A Schalken

M2M concentrates all expertise and facilities needed for imaging (molecule-to-man) and translational innovation (bench-to-bed)

AMBITION

A) Imaging from molecule-to-man B)Translational research – from bench-to-bed

Molecular imaging

(Sub)cellular imaging

Organ & body imaging

Imag

ing

Prod

ucti

on

Clinical imaging(volunteers, patients)

Preclinical imaging (in vitro / in vivo)

Small scale GMP-production &

labeling

Chemical synthesis

1

2

3

4

Basic science & discovery

Pre-clinical testing

Proof of concept

Clinical Trials

Individualized medicine & evidence based practice

small molecule virus ribosome animal cell drosophila mouse

10nm 100nm 10 μ 100 μ 1cm 1dm 1m

Globular protein bacterium plant cell mosquito homo sapiens

New biomarkers for prostate cancer are ‘ready for prime time’

Biomarker Substrate Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6GSTP1+methylation

Urine/Bx yes yes ongoing ongoing yes no

PCA3DD3 Urine yes yes yes yes End 2006PROGENSATM

Gen-ProbeCE-marked

2007/2008 PROGENSATM

Gen-Probe

T2-erg Urine yes yes yes ongoing yes no

DRE

Cells in Prostatic urethra

‘..Molecular Uroscopy..’Progensa PCA3

2003

•Unique biomarker and urine as specimen (can be obtained non invasively)

‘Science in practise’ (1996-2003)‘Science to business’ (2003-2006)

•Diagnocure (2000; PCA3 license from RUNMC)•Genprobe (2003; sublicense PCA3 based

molecular diagnostics)•2007; Progensa PCA3 launched

What now?

•PCA3 is a ‘specialty’ test • Expertise• Dedicated personel• Facilities

•NL needs an Oncology Specialty Lab!!

•Solution: found one yourselves• Opportunity meets ambition

‘Times they are a changin’

Knowledge valorisation ‘95•Ad hoc, often attenuating

& ‘06•Pro-active, enabling

NoviogendixA spin off from the Radboud University Nijmegen Medical Center

Noviogendix

•Founded November 2006 by two RUNMC scientists and a business developer

•First round financing Dec 2007 (Biogeneration Ventures, PPM Oost)

•Clear terms between Radboud & Noviogendix• Full transparency• Clearly defined • Negotiations took 6 months (much better than average)

Molecular Diagnostics‘core business’

•Specialty Oncology Laboratory • Extensive panel for infectious diseases• First on the EC market with PrCa marker,

-Progensa PCA3-• Expanding prostate cancer test panel• Expanding in other GU(genito-urinary) diseases

•Research• Marker IP portfolio GU

•Molecular profiling PrCa, RCC, TCC•Target validation (well annotated biorespositories)

Technology & fields of expertise

•Core technology: molecular/gene based diagnostics•Real time PCR (Roche)•NASBA (Biomerieux)•APTIMA DTS 400 (Genprobe)

•Disease focus• Oncology

•GU(genito-urinary)

• Infectious diseases

Noviogendix y

•Good functioning management team (founders)•Efficient and effective marketing and sales team (2)•Key personel for research •10 people in total

•Milestones• > 2000 tests sold• New IPR• Health kennis clusterregeling gemeente Nijmegen• Co-applicant for CTMM & PIDON

Noviogendix Oncology Specialty Laboratory

•Netherlands•UK•Germany•Belgium•France•Sweden•Italy•Misc. Overseas (incl south America and Australia)

Noviogendix Oncology Specialty Laboratory

Noviogendix Research

•RU(NMC) together with Health valley and the city of Nijmegen provide good soil for biotechnological initiatives

•Growing entrepreneurial spirit at RUNMC•Noviogendix can be ‘launched’ in 2009

Noviogendix Challenges

•Strengthen the management team•Be prepared for a second round of financing•Oncology Specialty Laboratory

• Move to new facility and get certification• Develop strategy to increase sales• Extend test portfolio

•Research• Validation of markers• Explore the licensing opportunities

(in- and out-)