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The regulatory landscape for actively personalized cancer immunotherapies

Nature Biotechnology volume 31, pages 880–882 (2013)Cite this article

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To the Editor:

Figure 1 shows three types of approaches towards precision tumor immunotherapy. The first type (Fig. 1a) is characterized by biomarker-based stratification of patients to be treated with one invariant drug product. Typically, patients are identified who express predictive biomarkers such as HER2 (also known as ERBB2), KRAS or epidermal growth factor receptor (EGFR) mutations. This kind of personalization is well covered by the existing regulatory framework originally intended for the development of chemical and biological drug products.

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Figure 1: Three levels of personalization in cancer immunotherapies.

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Acknowledgements

U.K. participated on behalf of the CIMT Regulatory Research Group. Twincore, Centre for Experimental and Clinical Infection Research, is a joint venture between the Hannover Medical School and the Helmholtz Centre for Infection Research, Hannover, Germany.

Author information

Author notes

  1. Cedrik M Britten and Harpreet Singh-Jasuja: These authors contributed equally to this work.

  2. Thomas Hinz and Ulrich Kalinke: These authors jointly supervised this work.

Authors and Affiliations

  1. TRON - Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz gGmbH, Mainz, Germany

    Cedrik M Britten, Sebastian Kreiter & Ugur Sahin

  2. Ribological GmbH, Mainz, Germany

    Cedrik M Britten

  3. Immatics Biotechnologies GmbH, Tübingen, Germany

    Harpreet Singh-Jasuja

  4. URPhyM, NARILIS, University of Namur, Namur, Belgium

    Bruno Flamion

  5. GlaxoSmithKline, Collegeville, Pennsylvania, USA

    Axel Hoos

  6. Association for Cancer Immunotherapy, Mainz, Germany

    Christoph Huber

  7. Curevac GmbH, Tübingen, Germany

    Karl-Josef Kallen

  8. Georgia Health Sciences University Cancer Center, Augusta, Georgia, USA

    Samir N Khleif

  9. Celldex Therapeutics Inc., Needham, Massachusetts, USA

    Michaela Nielsen

  10. University of Tübingen, Tübingen, Germany

    Hans-Georg Rammensee

  11. BioNTech AG, Mainz, Germany

    Ugur Sahin

  12. Paul-Ehrlich-Institut, Langen, Germany

    Thomas Hinz

  13. Twincore, Centre for Experimental and Clinical Infection Research, Hannover, Germany

    Ulrich Kalinke

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  1. Cedrik M Britten
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Corresponding author

Correspondence to Ulrich Kalinke.

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Competing interests

H.S.-J. is employee and shareholder of Immatics Biotechnologies GmbH, which has a commercial interest in development of cancer immunotherapies.

C.H. is co-founder, advisor and deputy-chairman of BioNTech. BioNTech develops highly individualized mutational epitope tumor vaccines.

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Britten, C., Singh-Jasuja, H., Flamion, B. et al. The regulatory landscape for actively personalized cancer immunotherapies. Nat Biotechnol 31, 880–882 (2013). https://doi.org/10.1038/nbt.2708

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