Overcoming Obstacles in the Development of Antigen-Specific Immunotherapies for Type 1 Diabetes

Antigen-specific immunotherapy (ASI) holds great promise for type 1 diabetes (T1D). Preclinical success for this approach has been demonstrated , however, clinical translation is still pending. Reasons explaining the slow progress to approve ASI are complex and span all stages of research and develo...

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Bibliographic Details
Published in:Frontiers in immunology 2021-08, Vol.12, p.730414-730414
Main Authors: Thomas, Ranjeny, Carballido, José M, Wesley, Johnna D, Ahmed, Simi T
Format: Article
Language:English
Subjects:
Animals
Antigens - immunology
Autoimmunity
Biomarkers - metabolism
Diabetes Mellitus, Type 1 - immunology
Diabetes Mellitus, Type 1 - metabolism
Diabetes Mellitus, Type 1 - therapy
Humans
Immunology
immunotherapy
Immunotherapy - adverse effects
precision medicine
T1D
tolerance
Translational Research, Biomedical
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Summary:Antigen-specific immunotherapy (ASI) holds great promise for type 1 diabetes (T1D). Preclinical success for this approach has been demonstrated , however, clinical translation is still pending. Reasons explaining the slow progress to approve ASI are complex and span all stages of research and development, in both academic and industry environments. The basic four hurdles comprise a lack of translatability of pre-clinical research to human trials; an absence of robust prognostic and predictive biomarkers for therapeutic outcome; a need for a clear regulatory path addressing ASI modalities; and the limited acceptance to develop therapies intervening at the pre-symptomatic stages of disease. The core theme to address these challenges is collaboration-early, transparent, and engaged interactions between academic labs, pharmaceutical research and clinical development teams, advocacy groups, and regulatory agencies to drive a fundamental shift in how we think and treat T1D.
ISSN:1664-3224
1664-3224
DOI:10.3389/fimmu.2021.730414