POSTBUS 578 3720 AN BILTHOVEN TEL.: 030 274 2777 FAX: 030 274 4476 [email protected] WWW.COGEM.NET CGM 2014-08 GM Vaccines: GM Vaccines: From bench to bedside From bench to bedside ONDERZOEKSRAPPORT ONDERZOEKSRAPPORT CGM 2014 - 08 2014 J.H.C.M. Kreijtz B. Ramezanpour K.D.S. Fernald L.H.M. van de Burgwal GM VACCINES: FROM BENCH TO BEDSIDE An investigation performed for The Netherlands Commission on Genetic Modification (COGEM) GM Vaccines: From Bench to Bedside 2014 © 2014 – COGEM and Viroscience Lab – All Rights Reserved Page | 2 GM Vaccines: From Bench to Bedside 2014 TABLE OF CONTENTS DISCLAIMER COGEM .............................................................................................................................................. 6 DISCLAIMER AUTHORS .......................................................................................................................................... 6 COPYRIGHT ............................................................................................................................................................ 6 AUTHORS ............................................................................................................................................................... 6 PREFACE ................................................................................................................................................................ 7 DELINEATION OF GENETICALLY MODIFIED VACCINE DEFINITIONS ......................................................................... 8 DEFINITIONS AND ABBREVIATIONS ....................................................................................................................... 9 VACCINE TYPES .................................................................................................................................................... 10 LIMITATIONS OF THIS STUDY ............................................................................................................................... 11 1. INTRODUCTION ........................................................................................................................................... 14 1.1 BACKGROUND ................................................................................................................................................ 14 1.2 PROJECT OUTLINE ........................................................................................................................................... 15 1.3 REPORT OUTLINE ............................................................................................................................................ 17 2. MARKET ...................................................................................................................................................... 20 2.1 METHODOLOGY .............................................................................................................................................. 20 2.2 REGISTERED GM VACCINES ............................................................................................................................... 22 2.3 VACCINE TARGET PATHOGENS ............................................................................................................................ 23 2.4 APPLICATION FIELDS ........................................................................................................................................ 24 2.5 VACCINE DEVELOPMENT/PRODUCTION TECHNOLOGIES ........................................................................................... 26 2.6 VACCINES FOR COMPANION ANIMALS .................................................................................................................. 29 2.7 EXOTIC ANIMAL VACCINES (WILDLIFE & ZOO) ....................................................................................................... 30 2.8 HIGHLIGHTS ................................................................................................................................................... 31 3. CLINICAL DEVELOPMENT ............................................................................................................................. 34 3.1 METHODOLOGY .............................................................................................................................................. 34 3.2 INDICATIONS .................................................................................................................................................. 36 3.3 VACCINE TECHNOLOGIES ................................................................................................................................... 39 3.4 VACCINE DEVELOPERS ...................................................................................................................................... 45 3.5 FUTURE EXPECTATIONS ..................................................................................................................................... 46 3.6 HIGHLIGHTS ................................................................................................................................................... 47 4. PRECLINICAL DEVELOPMENT ....................................................................................................................... 50 4.1 METHODOLOGY .............................................................................................................................................. 50 4.2 RESULTS ........................................................................................................................................................ 50 4.3 HIGHLIGHTS ................................................................................................................................................... 54 5. LATEST TRENDS ........................................................................................................................................... 56 5.1 NVGCT SPRING SYMPOSIUM 2014 - 14TH OF MARCH 2014 ................................................................................ 56 © 2014 – COGEM and Viroscience Lab – All Rights Reserved Page | 3 GM Vaccines: From Bench to Bedside 2014 TH 5.2 WORLD VACCINE CONGRESS 2014 - 24-26 OF MARCH 2014 .............................................................................. 56 TH 5.3 VACCINE TECHNOLOGY V - 8-13 OF JUNE 2014 ................................................................................................. 58 5.4 HIGHLIGHTS ................................................................................................................................................... 59 6. PATENTS ...................................................................................................................................................... 62 6.1 METHODOLOGY .............................................................................................................................................. 62 6.2 INDICATION AND TARGETS ................................................................................................................................ 64 6.3 TECHNOLOGY ................................................................................................................................................. 65 6.4 GEOGRAPHY ................................................................................................................................................... 66 6.5 TRENDS ......................................................................................................................................................... 67 6.6 HIGHLIGHTS ................................................................................................................................................... 69 7. EXPERT OPINIONS ....................................................................................................................................... 72 7.1 METHODOLOGY .............................................................................................................................................. 72 7.2 RESULTS ........................................................................................................................................................ 73 7.3 HIGHLIGHTS ................................................................................................................................................... 77 8. DISCUSSION ................................................................................................................................................. 80 8.1 WHAT IS AVAILABLE NOW AND WHAT CAN WE EXPECT? .......................................................................................... 80 8.2 CHANGES IN THE VACCINE INDUSTRY LANDSCAPE ................................................................................................... 83 8.3 PRODUCTION PLATFORMS ................................................................................................................................. 83 8.4 ENVIRONMENTAL RISKS OF GENETICALLY MODIFIED VACCINES .................................................................................. 83 8.5 SUMMARIZING STATEMENT ............................................................................................................................... 85 8.6 GENERAL RECOMMENDATIONS .......................................................................................................................... 86 ACKNOWLEDGEMENTS