- COMMENT
A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics
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By
- Miriam Meyer0,
- Andrea Mahr1,
- Joanna Brewer2,
- Volker Daniel3,
- Justine Dell‘Aringa4,
- Tony Goldstone5,
- Sarah Hersey6,
- Ian Johnston7,
- Pamela Larson8,
- Michael Loveridge9,
- Gavin MacBeath10,
- Mark Moyer11,
- Dirk Nagorsen12,
- Sophie Papa13,
- Leanne Peiser14,
- Koustubh Ranade15,
- Ruben Rizzi16,
- Axel Roers17,
- Dolores Schendel18,
- Pallavur Sivakumar19,
- Eric Tran20,
- Özlem Türeci21,
- Luise Weigand22,
- Anders Wennborg23,
- Dennis Williams24,
- Cassian Yee25 &
- …
- Cedrik M. Britten26
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Miriam Meyer
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Immatics Biotechnologies GmbH, Tübingen, Germany. M.M. and A.M. contributed equally.
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Andrea Mahr
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Immatics Biotechnologies GmbH, Tübingen, Germany. M.M. and A.M. contributed equally.
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Joanna Brewer
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Adaptimmune LLC, Philadelphia, PA, USA.
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Volker Daniel
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Institute for Immunology, University Hospital Heidelberg, Heidelberg, Germany.
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Justine Dell‘Aringa
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Bristol-Myers Squibb, New York, NY, USA.
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Tony Goldstone
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HCA Healthcare UK, London, UK.
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Sarah Hersey
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Bristol-Myers Squibb, New York, NY, USA.
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Ian Johnston
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Miltenyi Biotec, Bergisch Gladbach, Germany.
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Pamela Larson
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Medigene AG, Martinsried, Planegg, Germany.
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Michael Loveridge
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T-knife Therapeutics, San Francisco, CA, USA.
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Gavin MacBeath
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TScan Therapeutics, Waltham, MA, USA.
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Mark Moyer
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Immunocore, Abingdon, UK.
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Dirk Nagorsen
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Affini-T Therapeutics, Watertown, MA, USA.
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Sophie Papa
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Enara Bio, Oxford, UK; King’s College London, London, UK.
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Leanne Peiser
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Bristol-Myers Squibb, New York, NY, USA.
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Koustubh Ranade
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Immunocore, Abingdon, UK.
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Ruben Rizzi
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BioNTech SE, Mainz, Germany.
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Axel Roers
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Institute for Immunology, University Hospital Heidelberg, Heidelberg, Germany.
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Dolores Schendel
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Medigene AG, Martinsried, Planegg, Germany.
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Pallavur Sivakumar
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Bristol-Myers Squibb, New York, NY, USA.
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Eric Tran
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Providence Cancer Institute, Portland, OR, USA.
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Özlem Türeci
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BioNTech SE, Mainz, Germany; Helmholtz Institute TRON, Mainz, Germany.
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Luise Weigand
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Zelluna Immunotherapy AS, Oslo, Norway.
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Anders Wennborg
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Miltenyi Biomedicine, Bergisch Gladbach, Germany.
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Dennis Williams
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Adaptimmune LLC, Philadelphia, PA, USA.
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Cassian Yee
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The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
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Cedrik M. Britten
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Immatics Biotechnologies GmbH, Tübingen, Germany.
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Nature Reviews Drug Discovery 23, 1-2 (2024)
doi: https://doi.org/10.1038/d41573-023-00189-4
References
Nathan, P. et al. Overall survival benefit with tebentafusp in metastatic uveal melanoma. N. Engl. J. Med. 385, 1196–1206 (2021).
Hong, D. S. et al. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial. Nat. Med. 29, 104–114 (2023).
Directorate-General for Health and Food Safety. MDCG 2022-2 - Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs). European Commission https://health.ec.europa.eu/latest-updates/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en (2022).
Supplementary Information
Competing Interests
The authors declare competing interests, including working for companies that are developing TCR-based therapies. Please see Supplementary information for further details.
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