IRE ELiT. 6 th Symposium on Medical Isotopes Mechelen, 11 May Philippe van Put IRE ELiT. Ge/ 68 Ga generator: first evaluation

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1 IRE ELiT 68 Ge/ 68 Ga generator: first evaluation 6 th Symposium on Medical Isotopes Mechelen, 11 May 2017 Philippe van Put IRE ELiT

2 Where we start Creation of IRE and first constructions Worldwide leadership in the production of 99 Mo, 131 I and 133 Xe Creation of the IRE ELiT subsidiary New development in radiopharma activities ( 188 Re, 68 Ga, etc.) Launch of Galli Eo ( 68 Ga generator) -GMP certification of the radiopharma facility -Europe filing for Marketing authorization

3 IRE Elit : innovation centre for IRE DELIVERY SOLUTIONS FOR RADIOPHARMACEUTICALS Better access to PET Imaging isotopes Better access to Theragnostic RESEARCH PROGRAMS & EXPERTS BOARD COMPLIANT GMP CERTIFICATION Strategy: Working with the users, in a test and learn mode for short time to market and quick results.

4 R&D investments 12.0% 10.0% 8.0% R&D spending vs Revenue 7.0% 8.9% 10.2% 6.0% 4.0% 2.0% 3.8% 5.4% 0.0%

5 Nuclear Medicine Diagnostic Ideal world Radio-isotope has to be easily accessible on demand with limited infrastructures Vectors should be widely available Linking the radio-isotope and the Vector should be: As easy as possible As fast as possible Risk of failure should be as low as possible (patient safety) Collected information should be accurate and relevant

6 Nuclear Medicine Diagnostic real world SPECT 99 Mo/ 99m Tc Produced by a generator Widely available at low price Standardized protocol Vector kits available for a lot of pathologies Simple to use kits «shake and bake» type Basic laboratory Quantification limitation Image quality PET F18 Cyclotron production Commercially widely available - price depends of distance to cyclotron Combination with a Vector requires a synthesis process Automation required because of radiation Complex laboratory Better quantification Improved image quality

7 So Ideal world is «Doing PET as simply as SPECT» -> PET Generator similar to 99 Mo/ 99m Tc -> Direct labelling =«Shake and go to the patient» Where to look at.

8 68 Ga properties Physical properties T 1/2 = 68 min b + : 89% 68 Ge/ 68 Ga generator based production Mother 68 Ge cyclotron produced (T 1/2 = 271 d) Chemical properties Trivalent metal Chelation chemistry Applicability Short half-life molecules with fast biokinetics (Peptides, Ab-fragments, )

9 Gallium-68: new high potential PET tracer Ga-68 publications Ga-68 clinicals trials 107* (2017) EU 31 USA 30 Asia 42 Canada 3 ROW 20 * clinicaltrial.gov

10 Galli EoTM generator

11 Galli Eo Story A user-friendly generator designed in 3 parts 1- SIMPLE Original mechanism to deliver a fixed and small vol: 1,1 ml 2- INNOVATIVE Specific column SUSTAINABLE Eluent inside for the entire shelf life: 450 elutions

12 Galli Eo SIMPLICITY 1- Original mechanism to deliver a fixed and small vol: 1,1 ml 1 High concentration No need for concentration /fractionning Fast reaction time Tailored for kit form compound

13 In practice: elution with vaccum vial The elution can be performed connected to chemistry module clic

14 Galli Eo INNOVATION 2-Specific column 2 IRE exclusive design Inorganic material with high Germanium affinity Very low breaktrough No need for prepurification (and especially no waste generated by this step) No elution after week-end

15 Galli Eo SUSTAINABILITY 3-Eluent inside 3 Sterility guarantee Extended shelf-life :450 elutions Full control of the chromatographic system à stability of specifications during the whole shelflife

16 Galli Eo Story SIMPLE & INNOVATIVE à ready for cold kits direct labelling COST EFFECTIVE à «all inclusive» solution No module, no cassette, no eluent to replace Quick & high activity: more patient / dose SUSTAINABLE à no waste generated à return of the generator at the end of its life Lowest cost per dose solution compared to others!

17 Galli Eo first evaluation A test user testimony Had the Galli Eo been a box of Belgian chocolates, it would not have brought a brighter smile to my face. To date we have performed 17 elutions. The Ga-68 yield and recharge have been just as predicted. Its ease of operation and the short time to elute have been a dream. In fact three different pharmacist have had the opportunity to elute the unit to date. Success story no doubts!

18 Clinical Perspectives with Gallium -68 compared to F-18 Diagnostic 18 F/ 11 C 68 Ga Angiogenesis General cancer imaging [ 18 F]-galacto-RGD [ 18 F]-FDG [ 68 Ga]DOTA-RGD [ 68 Ga]-VEGF [ 68 Ga]-CXCR4 biomarker [ 68 Ga]-uPAR biomarker [ 68 Ga]-SCN-NOTA-BZA Hypoxia [ 18 F]-nitromidazoles (FAZA, FMISO, FETNIM) [ 68 Ga]-DOTA-imidazoles Proliferation [ 18 F]-FLT [ 68 Ga]-DO3A-thymidine Glioma NET Prostate cancer [ 18 F] FET [ 11 C]methionine [ 18 F] FDOPA [ 18 F]/[ 11 C]-HTP [ 18 F]FDG [ 11 C]acetate [ 18 F]/[ 11 C]choline [ 68 Ga]-glutamine [ 68 Ga]-DO3A-alanine [ 68 Ga]-DO2A-tyrosine [ 68 Ga]-DOTATOC/NOC/TATE [ 68 Ga]-HBED-CC-PSMA

19 Making PET as simple as SPECT Conclusion A PET generator as simple/reliable as a SPECT generator is available A lot of work are under progress for testing new vectors Some vectors to combine to 68 Ga are close to get Marketing Approval (few weeks to months) 68 Ga is likely to play a significant role in diagnostics in the next 3-5 years.

20 More information

21 Contacts Sales administration: Cynthia Hambenne T Business development Philippe van Put T Marketing: Bérénice Pignol T

22 Thank you for your attention