Mathieu, Chantal http://orcid.org/0000-0002-4055-5233
Wiedeman, Alice http://orcid.org/0000-0001-7329-7288
Cerosaletti, Karen http://orcid.org/0000-0002-7403-6239
Long, S. Alice http://orcid.org/0000-0002-0281-1240
Serti, Elisavet http://orcid.org/0000-0003-4129-0254
Cooney, Laura http://orcid.org/0000-0002-2374-3806
Vermeiren, Joan http://orcid.org/0000-0001-9458-1739
Caluwaerts, Silvia http://orcid.org/0009-0002-0422-5584
Van Huynegem, Karolien http://orcid.org/0009-0006-8004-2519
Steidler, Lothar http://orcid.org/0000-0001-6026-476X
Blomme, Sven http://orcid.org/0009-0005-4098-9954
Rottiers, Pieter http://orcid.org/0000-0003-2252-3032
Nepom, Gerald T. http://orcid.org/0000-0002-8063-1464
Herold, Kevan C. http://orcid.org/0000-0003-1534-6613
,
Funding for this research was provided by:
National Institute of Allergy and Infectious Diseases (UM1AI109565)
Article History
Received: 24 May 2023
Accepted: 21 July 2023
First Online: 2 October 2023
Acknowledgements
: The authors would like to thank all investigators and people who participated in the study. Medical writing support was provided by A. Rombout and F. Baert, Emtex Life Science, Belgium. A. Haegeman, E. Festjens and K. Vandenbroucke from Precigen ActoBio contributed to PK sample and data analysis. C. Acosta-Vega from Benaroya Research Institute Human Immunophenotyping Core contributed to CyTOF panel development and staining. E. Balmas, J. L. Blanchfield and J. Chen from Benaroya Research Institute developed the spectral cytometry panels, performed the activation-induced marker assays and analysed the spectral cytometry data.
: The data that support the findings of this study are not openly available for reasons of sensitivity. The sponsor may, at its discretion, grant access to the data (or portions thereof) to qualified researchers on reasonable request; however, access may be subject to certain use and/or privacy obligations.
: This clinical trial was funded by Intrexon Actobiotics N.V. d/b/a Precigen ActoBio. The mechanistic assays and immunological data analysis were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under award no. UM1AI109565. This report is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
: CM serves or has served on advisory panels for Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, Precigen ActoBio, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz and Vertex. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic, Imcyse, Novo Nordisk, Sanofi and Precigen ActoBio; CM serves or has served on speakers bureaus for Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, Astra Zeneca and Novartis. Financial compensation for these activities has been received by KU Leuven. CM is president of the EASD. All external support of the EASD is to be found on ExternalRef removed. JV, SC, KVH, LS, SB and PR are employed by Precigen ActoBio. KC has received funding from Cour Pharmaceuticals and Gentibio. GTN has consulted for Precigen ActoBio as an advisor to the Precigen ActoBio programme. SAL is a consultant for Provention Bio and Sonoma Bio, a co-inventor on a patent filing (‘Methods and compositions for preventing type 1 diabetes’) and a member of the mechanistic study panels for TrialNet and ITN. KCH is a co-inventor on teplizumab patents.
: CM, AW, KC, SAL, ES, LC, JV, SC, KVH, LS, SB, PR, GTN and KCH contributed to the study design; data collection, analysis and interpretation; and drafting and critical revision of the article. All authors approved the final version to be published. PR is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.