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Imaging Biomarkers (IBs) for Safer Drugs: Validation of Translational Imaging Methods in Drug Safety Assessment - Sofia ref.: 116106

Deliverables

Manuscript on novel 89Zr-GLP-1 peptide conjugation

An ARRIVE-compliant manuscript submitted for open-access publication describing the design and synthesis the GLP-1 site-specifically conjugated to the optimised 89Zr chelate, the design and synthesis the GLP-1 site-specifically conjugated to IRDye 800CW, molecular integrity and stability of GLP-1 conjugates analytically verified through LC-MS, in vitro evaluation of properties of 89Zr-labelled GLP-1 conjugate: chemical purity, stability, degradation, suitability for in vivo administration, in vivo evaluation of properties of 89Zr-labelled GLP-1 conjugate and IRDye 800CW GLP-1 conjugate Responsible for coordinating and assembling entire manuscript: Dijon Verification: (1) PDF of manuscript; (2) Email from journal acknowledging receipt of manuscript; (3) Minutes of WP4 meeting prospectively justifying sample size for animal experiments; (4) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable; (5) url of the site (5.0.D4) containing any SOPs and any exemplar data-sets associated with this deliverable. Responsible for mouse imaging: Nijmegen Responsible for analytic verification: Nijmegen GNG 4.1.G4: Thermodynamic and kinetic stability of 89Zr in these novel chelates in blood (in vitro) as well as physicochemical properties of labeled compounds should jusify further animal experiments Site-specific conjugated 89Zr-conjugated GLP-1 and the fluorescent analogue, in vitro are impressive enough to justify further animal experiments Verification: Minutes of WP4 meeting Consequence: If conjugate is unimpressive, previously existing Zr chelates will be used for further studies Date: M18

Manuscript on chronic bleomycin MR&PET

An ARRIVE-compliant manuscript submitted for open-access publication which (a) characterizes the progression of bleomycin-induced lung inflammation and fibrosis in rats using suitable imaging biomarkers employing 1H-MRI and PET/CT using tracers for inflammation (e.g. FDG), and for structural change (e.g. collagen 1) (b) correlates imaging biomarkers with conventional evaluation such as histology, cells, and protein expression; If the studies are negative, report of the negative findings. Responsible: Lund/Truly Verification: (1) Minutes of WP3 meeting (2) Pdf of manuscript; (3) Email from journal acknowledging receipt of manuscript Date: M42 GNG 3.3.G1 GO: PET/CT or MRI biomarkers improve the characterization of progression in rats of bleomycin-induced lung inflammation vs fibrosis. Verification: Minutes of WP3 Date: M24 Consequence: If the imaging biomarkers are uninformative, NO-GO for multisite preclinical evaluation

manuscript on food effects on BSEP function in patients

A manuscript submitted for open-access publication describing food effects in healthy volunteers on the basal activity of BSEP. This deliverable is conditional and subject to Pfizer internal approval as well as to approval by the EMA Responsible: Pfizer Verification: (1) pdf of manuscript; (2) email from journal acknowledging receipt of submitted manuscript; (3) prospective study protocol and sample size (power) calculation appended to WP2 minutes; (4) clinical trial identification number from a recognised clinical trial registry such as clinicaltrials.gov; (5) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable; (6) url of the site (5.0.D4) containing any SOPs and any exemplar data-sets associated with this deliverable ; (7) the data sharing statement..

Manuscript on use of 89Zr pembrolizumab in NHPs

An ARRIVE-compliant manuscript submitted for open-access publication describing 89Zr-pembrolizuab in NHP Responsible: MSD Verification: (1) Minutes of WP4 meeting including prospective sample size calculation and prospective protocol; (2) Opinion of TRISTAN’s independent Ethics Advisory Board that use of NHP is justified in the context of the entire project goals; (3) PDF of manuscript; (4) Email from journal acknowledging receipt of manuscript; (4) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable; (5) url of the site (5.0.D4) containing any SOPs and any exemplar data-sets associated with this deliverable. GNG 4.3.G3: In vivo experiments in NHP justify a clinical study Verification: Minutes of WP4 meeting Consequence: Non-human primate study will not be performed Date: M29

Manuscript on physician approaches to DIILD

A survey of physician approaches to treatment of DIILD from drugs with known DIILD risk, submitted for open-access publication Responsible for coordinating and assembling entire manuscript: Sheffield Responsible for contributing Sheffield, Bioxydyn, Manchester, Verification: (1) Pdf of manuscript; (2) Email from journal acknowledging receipt of manuscript

Manuscript on imaging cellular vs non-cellular components

An ARRIVE-compliant manuscript submitted for open-access publication which characterizes the set-up and characterization of cellular vs. non-cellular components of chronic bleomycin-induced lung fibrosis in rats using (a) suitable 1H-MRI and/or PET imaging biomarkers and (b) discusses implications for clinical assessment, (c) correlates imaging biomarkers with conventional evaluation such as histology, cells, protein expression and ‘lung function’. Reports to include also negative findings. Responsible for coordinating and assembling entire manuscript: Lund/Truly Verification: (1) Minutes of WP3 meeting including prospective sample size calculation and prospective protocol; (2) Pdf of manuscript; (3) Email from journal acknowledging receipt of manuscript GNG 3.3 G2: GO: Novel chronic bleomycin model improves the translatability of animal model to clinical setting. Imaging biomarkers suing MRI and/or PET/CT improve characterization of cellular vs. non-cellular components of bleomycin-induced lung fibrosis in a chronic rat model. Verification: (1) Minutes of WP3 meeting Consequence: If the imaging biomarkers are uninformative: NO-GO for multisite preclinical evaluation; NO-GO for progression into man Date: M36

Manuscript on simplified IL2 labeling method

A manuscript submitted for open-access publication describing a simplified method that could be applied in multicentre studies to produce a 68Ga or 18F-labelled IL2-based PET tracer. Responsible for coordinating and assembling entire manuscript: Nijmegen Responsible for contributing: Groningen Verification: (1) PDF of manuscript; (2) Email from journal acknowledging receipt of manuscript; (3) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable; (4) url of the site (5.0.D4) containing any SOPs and any exemplar data-sets associated with this deliverable. GNG 4.3.G1: a simplified method that could be applied in multicentre studies to produce a 68Ga or 18F-labelled IL2-based PET tracer Verification: Minutes of WP4 meeting Consequence: IL2 tracer will not be used in 4.3.D2 Date: M18

Manuscript for gadoxetate relaxivities

A manuscript submitted for open-access publication reporting the different relaxivities of gadoxetate between extra- and intracellular space characterised by in vitro studies at relevant field strengths. May be either a stand-alone manuscript or alternatively included as a section or supplementary material in a broader manuscript. Responsible for coordinating work assembling entire manuscript: Bayer Responsible for contributing data: Bayer, MSD, Sanofi Verification: (1) pdf of manuscript; (2) email from journal acknowledging receipt of submitted manuscript; (3) A copy of the page on the TRISTAN data inventory (5.0.D1) which shows a record for the data acquired in order to generate this deliverable.

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Publications

Imaging Biomarkers and Pathobiological Profiling in a Rat Model of Drug-Induced Interstitial Lung Disease Induced by Bleomycin

Author(s): Irma Mahmutovic Persson, Hanna Falk Håkansson, Anders Örbom, Jian Liu, Karin von Wachenfeldt, Lars E. Olsson
Published in: Frontiers in Physiology, 11, 2020, ISSN 1664-042X
Publisher: Frontiers Research Foundation
DOI: 10.3389/fphys.2020.00584

Survey of water proton longitudinal relaxation in liver in vivo

Author(s): John Charles Waterton
Published in: Magnetic Resonance Materials in Physics, Biology and Medicine, 34(6), 2021, ISSN 2213-7793
Publisher: Springer
DOI: 10.1007/s10334-021-00928-x

S75 Hyperpolarised 129-xenon MRI in differentiating between fibrotic and inflammatory interstitial lung disease and assessing longitudinal change

Author(s): JA Eaden, GJ Collier, G Norquay, H-F Chan, PJC Hughes, ND Weatherley, S Rajaram, A Swift, CT Leonard, S Skeoch, N Chaudhuri, GJM Parker, SM Bianchi, JM Wild
Published in: Thorax, 76, 2021, ISSN 0040-6376
Publisher: BMJ Publishing Group
DOI: 10.1136/thorax-2020-btsabstracts.80

Development and Evaluation of Interleukin-2–Derived Radiotracers for PET Imaging of T Cells in Mice

Author(s): Elly L. van der Veen, Frans V. Suurs, Frederik Cleeren, Guy Bormans, Philip H. Elsinga, Geke A.P. Hospers, Marjolijn N. Lub-de Hooge, Elisabeth G.E. de Vries, Erik F.J. de Vries, Inês F. Antunes
Published in: Journal of Nuclear Medicine, 61/9, 2020, Page(s) 1355-1360, ISSN 0161-5505
Publisher: Kexue Chubaneshe/Science Press
DOI: 10.2967/jnumed.119.238782

Physiologically Based Pharmacokinetic Modeling of Transporter-Mediated Hepatic Disposition of Imaging Biomarker Gadoxetate in Rats

Author(s): Daniel Scotcher, Nicola Melillo, Sirisha Tadimalla, Adam S. Darwich, Sabina Ziemian, Kayode Ogungbenro, Gunnar Schütz, Steven Sourbron, and Aleksandra Galetin
Published in: Mol. Pharmaceutics, 18, 8, 2021, ISSN 1543-8384
Publisher: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.1c00206

89Zr-pembrolizumab imaging as a non-invasive approach to assess clinical response to PD-1 blockade in cancer

Author(s): I. C. Kok, J. S. Hooiveld, P. P. van de Donk1y, D. Giesen1, E. L. van der Veen, M. N. Lub-de Hooge2, A. H. Brouwers, T. J. N. Hiltermann, A. J. van der Wekken4, L. B. M. Hijmering-Kappelle, W. Timens, S. G. Elias, G. A. P. Hospers, H. J. M. Groen, W. Uyterlinde, B. van der Hiel8, J. B. Haanen, D. J. A. de Groot, M. Jalving & E. G. E. de Vries
Published in: Annals of Oncology, VOLUME 33, ISSUE 1, P80-88, 2021, ISSN 0923-7534
Publisher: Oxford University Press
DOI: 10.1016/j.annonc.2021.10.213

Ex vivo gadoxetate relaxivities in rat liver tissue and blood at five magnetic field strengths from 1.41 to 7 T

Author(s): Sabina Ziemian, Claudia Green, Steven Sourbron, Gregor Jost, Gunnar Schütz, Catherine D.G. Hines
Published in: NMR in Biomedicine, 34/1, 2021, ISSN 0952-3480
Publisher: John Wiley & Sons Inc.
DOI: 10.1002/nbm.4401

Imaging Biomarkers in Animal Models of Drug-Induced Lung Injury: A Systematic Review

Author(s): Irma Mahmutovic Persson, Karin von Wachenfeldt, John C. Waterton, Lars E. Olsson
Published in: J. Clin. Med., 10(1), 107, 2021, ISSN 2077-0383
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm10010107

Longitudinal Imaging Using PET/CT with Collagen-I PET-Tracer and MRI for Assessment of Fibrotic and Inflammatory Lesions in a Rat Lung Injury Model

Author(s): Irma Mahmutovic Persson, Nina Fransén Pettersson, Jian Liu, Hanna Falk Håkansson, Anders Örbom, René In ’t Zandt, Ritha Gidlöf, Marie Sydoff, Karin von Wachenfeldt, Lars E. Olsson
Published in: Journal of Clinical Medicine, 9/11, 2020, Page(s) 3706, ISSN 2077-0383
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm9113706

PET/CT Imaging of 89Zr-N-sucDf-Pembrolizumab in Healthy Cynomolgus Monkeys

Author(s): Wenping Li, Yuchuan Wang, Daniel Rubins, Idriss Bennacef, Marie Holahan, Hyking Haley, Mona Purcell, Liza Gantert, SuChun Hseih, Michael Judo, Wolfgang Seghezzi, Shuli Zhang, Elly L. van der Veen, Marjolijn N. Lub-de Hooge, Elisabeth G.E. de Vries, Jeffrey L. Evelhoch, Michael Klimas, Eric D. Hostetler
Published in: Molecular Imaging and Biology, 23/2, 2021, Page(s) 250-259, ISSN 1536-1632
Publisher: Elsevier BV
DOI: 10.1007/s11307-020-01558-w

89 Zr-Immuno-Positron Emission Tomography in Oncology: State-of-the-Art 89 Zr Radiochemistry

Author(s): Sandra Heskamp, René Raavé, Otto Boerman, Mark Rijpkema, Victor Goncalves, Franck Denat
Published in: Bioconjugate Chemistry, 28/9, 2017, Page(s) 2211-2223, ISSN 1043-1802
Publisher: American Chemical Society
DOI: 10.1021/acs.bioconjchem.7b00325

Drug-Induced Interstitial Lung Disease: A Systematic Review

Author(s): Sarah Skeoch, Nicholas Weatherley, Andrew Swift, Alexander Oldroyd, Christopher Johns, Conal Hayton, Alessandro Giollo, James Wild, John Waterton, Maya Buch, Kim Linton, Ian Bruce, Colm Leonard, Stephen Bianchi, Nazia Chaudhuri
Published in: Journal of Clinical Medicine, 7/10, 2018, Page(s) 356, ISSN 2077-0383
Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm7100356

Synthesis and evaluation of zirconium-89 labelled and long-lived GLP-1 receptor agonists for PET imaging

Author(s): Christian Borch Jacobsen, René Raavé, Marie Østergaard Pedersen, Pierre Adumeau, Mathieu Moreau, Ibai E. Valverde, Inga Bjørnsdottir, Jesper Bøggild Kristensen, Mette Finderup Grove, Kirsten Raun, James McGuire, Victor Goncalves, Sandra Heskamp, Franck Denat, Magnus Gustafsson
Published in: Nuclear Medicine and Biology, 82-83, 2020, Page(s) 49-56, ISSN 0969-8051
Publisher: Elsevier BV
DOI: 10.1016/j.nucmedbio.2019.11.006

Tracers for non-invasive radionuclide imaging of immune checkpoint expression in cancer

Author(s): Peter Wierstra, Gerwin Sandker, Erik Aarntzen, Martin Gotthardt, Gosse Adema, Johan Bussink, René Raavé, Sandra Heskamp
Published in: EJNMMI Radiopharmacy and Chemistry, 4/1, 2019, ISSN 2365-421X
Publisher: Springer Nature
DOI: 10.1186/s41181-019-0078-z

Clinical-grade N-(4-[18F]fluorobenzoyl)-interleukin-2 for PET imaging of activated T-cells in humans

Author(s): Elly L. van der Veen, Inês F. Antunes, Petra Maarsingh, Janet Hessels-Scheper, Rolf Zijlma, Hendrikus H. Boersma, Annelies Jorritsma-Smit, Geke A. P. Hospers, Elisabeth G. E. de Vries, Marjolijn N. Lub-de Hooge, Erik F. J. de Vries
Published in: EJNMMI Radiopharmacy and Chemistry, 4/1, 2019, ISSN 2365-421X
Publisher: Springer Nature
DOI: 10.1186/s41181-019-0062-7

Direct comparison of the in vitro and in vivo stability of DFO, DFO* and DFOcyclo* for 89Zr-immunoPET

Author(s): René Raavé, Gerwin Sandker, Pierre Adumeau, Christian Borch Jacobsen, Floriane Mangin, Michel Meyer, Mathieu Moreau, Claire Bernhard, Laurène Da Costa, Adrien Dubois, Victor Goncalves, Magnus Gustafsson, Mark Rijpkema, Otto Boerman, Jean-Claude Chambron, Sandra Heskamp, Franck Denat
Published in: European Journal of Nuclear Medicine and Molecular Imaging, 46/9, 2019, Page(s) 1966-1977, ISSN 1619-7070
Publisher: Springer Verlag
DOI: 10.1007/s00259-019-04343-2

Experimental and quantitative imaging techniques in interstitial lung disease

Author(s): Nicholas D Weatherley, James A Eaden, Neil J Stewart, Brian J Bartholmai, Andrew J Swift, Stephen Mark Bianchi, Jim M Wild
Published in: Thorax, 74/6, 2019, Page(s) 611-619, ISSN 0040-6376
Publisher: BMJ Publishing Group
DOI: 10.1136/thoraxjnl-2018-211779

Repeatability and reproducibility of longitudinal relaxation rate in 12 small-animal MRI systems

Author(s): John C. Waterton, Catherine D.G. Hines, Paul D. Hockings, Iina Laitinen, Sabina Ziemian, Simon Campbell, Michael Gottschalk, Claudia Green, Michael Haase, Katja Hassemer, Hans-Paul Juretschke, Sascha Koehler, William Lloyd, Yanping Luo, Irma Mahmutovic Persson, James P.B. O'Connor, Lars E. Olsson, Kashmira Pindoria, Jurgen E. Schneider, Steven Sourbron, Denise Steinmann, Klaus Strobel, Sirisha Tad
Published in: Magnetic Resonance Imaging, 59, 2019, Page(s) 121-129, ISSN 0730-725X
Publisher: Elsevier BV
DOI: 10.1016/j.mri.2019.03.008

Feasibility of PET/CT system performance harmonisation for quantitative multicentre 89Zr studies

Author(s): Andres Kaalep, Marc Huisman, Terez Sera, Danielle Vugts, Ronald Boellaard
Published in: EJNMMI Physics, 5/1, 2018, ISSN 2197-7364
Publisher: Springer Nature
DOI: 10.1186/s40658-018-0226-7

How consistently do physicians diagnose and manage drug-induced interstitial lung disease? Two surveys of European ILD specialist physicians

Author(s): James A. Eaden, Sarah Skeoch, John C. Waterton, Nazia Chaudhuri, Stephen M. Bianchi
Published in: ERJ Open Research, 6/1, 2020, Page(s) 00286-2019, ISSN 2312-0541
Publisher: European Respiratory Society
DOI: 10.1183/23120541.00286-2019

Bias, Repeatability and Reproducibility of Liver T1 Mapping With Variable Flip Angles

Author(s): Sirisha Tadimalla PhD,Daniel J. Wilson PhD,David Shelley BSc,Gavin Bainbridge BSc,Margaret Saysell BSc,Iosif A. Mendichovszky MD,Martin J. Graves PhD,J. Ashley Guthrie MB,John C. Waterton PhD,Geoffrey J.M. Parker PhD,Steven P. Sourbron
Published in: Journal of Magnetic Resonance Imaging, 2022, ISSN 1053-1807
Publisher: John Wiley & Sons Inc.
DOI: 10.1002/jmri.28127

Drug-Induced Liver Toxicity

Author(s): Minjun Chen, Yvonne Will
Published in: Methods in Pharmacology and Toxicology, 2018, ISBN 978-1-4939-7677-5
Publisher: Springer New York
DOI: 10.1007/978-1-4939-7677-5

Noninvasive Preclinical and Clinical Imaging of Liver Transporter Function Relevant to Drug-Induced Liver Injury

Author(s): J. Gerry Kenna, John C. Waterton, Andreas Baudy, Aleksandra Galetin, Catherine D. G. Hines, Paul Hockings, Manishkumar Patel, Daniel Scotcher, Steven Sourbron, Sabina Ziemian, Gunnar Schuetz
Published in: Drug-Induced Liver Toxicity, 2018, Page(s) 627-651, ISBN 978-1-4939-7676-8
Publisher: Springer New York
DOI: 10.1007/978-1-4939-7677-5_30