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A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics

Current regulation of T cell receptor (TCR)-based therapeutics may require repeated testing of patients for specific HLA alleles as well as companion diagnostics development, despite the invariant nature of the HLA genotype and availability of robust clinical HLA tests. This increases the burden on patients and the organizations developing these products. We propose regulatory flexibility to facilitate the development of and access to TCR-based therapeutics.
By
  1. Miriam Meyer

    1. Immatics Biotechnologies GmbH, Tübingen, Germany. M.M. and A.M. contributed equally.

  2. Andrea Mahr

    1. Immatics Biotechnologies GmbH, Tübingen, Germany. M.M. and A.M. contributed equally.

  3. Joanna Brewer

    1. Adaptimmune LLC, Philadelphia, PA, USA.

  4. Volker Daniel

    1. Institute for Immunology, University Hospital Heidelberg, Heidelberg, Germany.

  5. Justine Dell‘Aringa

    1. Bristol-Myers Squibb, New York, NY, USA.

  6. Tony Goldstone

    1. HCA Healthcare UK, London, UK.

  7. Sarah Hersey

    1. Bristol-Myers Squibb, New York, NY, USA.

  8. Ian Johnston

    1. Miltenyi Biotec, Bergisch Gladbach, Germany.

  9. Pamela Larson

    1. Medigene AG, Martinsried, Planegg, Germany.

  10. Michael Loveridge

    1. T-knife Therapeutics, San Francisco, CA, USA.

  11. Gavin MacBeath

    1. TScan Therapeutics, Waltham, MA, USA.

  12. Mark Moyer

    1. Immunocore, Abingdon, UK.

  13. Dirk Nagorsen

    1. Affini-T Therapeutics, Watertown, MA, USA.

  14. Sophie Papa

    1. Enara Bio, Oxford, UK; King’s College London, London, UK.

  15. Leanne Peiser

    1. Bristol-Myers Squibb, New York, NY, USA.

  16. Koustubh Ranade

    1. Immunocore, Abingdon, UK.

  17. Ruben Rizzi

    1. BioNTech SE, Mainz, Germany.

  18. Axel Roers

    1. Institute for Immunology, University Hospital Heidelberg, Heidelberg, Germany.

  19. Dolores Schendel

    1. Medigene AG, Martinsried, Planegg, Germany.

  20. Pallavur Sivakumar

    1. Bristol-Myers Squibb, New York, NY, USA.

  21. Eric Tran

    1. Providence Cancer Institute, Portland, OR, USA.

  22. Özlem Türeci

    1. BioNTech SE, Mainz, Germany; Helmholtz Institute TRON, Mainz, Germany.

  23. Luise Weigand

    1. Zelluna Immunotherapy AS, Oslo, Norway.

  24. Anders Wennborg

    1. Miltenyi Biomedicine, Bergisch Gladbach, Germany.

  25. Dennis Williams

    1. Adaptimmune LLC, Philadelphia, PA, USA.

  26. Cassian Yee

    1. The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

  27. Cedrik M. Britten

    1. 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

  1. Nathan, P. et al. Overall survival benefit with tebentafusp in metastatic uveal melanoma. N. Engl. J. Med. 385, 1196–1206 (2021).

    Article  PubMed  Google Scholar 

  2. 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).

    Article  PubMed  Google Scholar 

  3. 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).

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Supplementary Information

  1. 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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