bart vandekerckhove ghent university
TRANSCRIPT
Bart VandekerckhoveGhent University
Production of investigationaladvanced therapy medicinal products for phase I clinical trials
CERTAIN TUMORS ARE IMMUNOGENIC
R.T. Prehn, J.M. Main
Immunity to
methylcholanthrene-induced
sarcomas
J. Natl. Cancer Inst., 18 (1957)
2
Adaptive immune resistance.
Daniel Morgensztern, and Roy S. Herbst Clin Cancer Res
2016;22:3713-3717
©2016 by American Association for Cancer Research3
IMMUNOGENIC TUMORS ARE CURABLE BY IMMUNE ACTIVATION
Number of somatic mutations in
representative human cancers,
detected by genome-wide
sequencing studies.
B Vogelstein et al.
Science 2013;339:1546-1558
Published by AAAS
5
CERTAIN TUMORS ARE IMMUNOGENIC
| MIDRIXNEO : MPLA-Interferon-activated neoantigen-targeted dendritic cell vaxine
GM-CSF
IL-4
IFNγ
MPLA
| Good manufacturing practices
GMP environment:
Controlled environment
Risk reduction
RISKS?
Starting
materials
ATMPmRNA
Apheresis
product
Drug substance:
mRNA electroporated
DC
Drug products: frozen
mRNA EP DC
Full documentation in the Investigational Medicinal Product Dossier
GMP facility and production process audited and licensed by FAGG
▪ Research
▪ Open systems
▪ Bovine serum
▪ GMP
▪ Closed systems
▪ No animal products
| Translation into a GMP compliant protocol
| Clean room: clean, cleaner, cleanest
Clean room environment atGMP unit 3 Cell Therapy UZ Ghent
• Qualified personnel
• Controlled environment
• Strict clothing requirements
• Control of devices
| MIDRIXNEO team
Principal investigatorsProf. Karim VermaelenProf. Bart Vandekerckhove
GMP productionProf. Bart VandekerckhovePam DevrekerSaskia DesmetNele LootensSarah Vanrenterghem
BioinformaticsProf. Bjorn MentenProf. Kathleen ClaesLaurenz De Cock
ImmunologyDr. Elisabeth BrabantsJoline IngelsKelly Heyns
ImmunopeptidomicsProf. Francis ImpensDr. Rupert Mayer
FarmacyProf Stefaan DE SmedtDr Ine LentackerDr Heleen De witte
SponsorsKom op tegen KankerUniversity of Ghent