Immunotherapies and immune biomarkers in Type 1 diabetes: A partnership for success

- Successful immunotherapies have not translated from mice to human for T1D.
- Developing immune biomarkers that translate from animal models to humans is required for success.
- Immune biomarkers in immunotherapy clinical trials are critical for assessing immune efficacy.
- Best practice standards for biomarker assays should be shared between industry and academia.

The standard of care (SoC) for Type 1 diabetes (T1D) today is much the same as it was in the early 1920s, simply with more insulin options-fast-acting, slow-acting, injectable, and inhalable insulins. However, these well-tolerated treatments only manage the symptoms and complications, but do nothing to halt the underlying immune response. There is an unmet need for better treatment options for T1D that address all aspects of the disease. For decades, we have successfully treated T1D in preclinical animal models with immune-modifying therapies that have not demonstrated comparable efficacy in humans. The path to bringing such options to the clinic will depend on the implementation and standard inclusion of biomarkers of immune and therapeutic efficacy in T1D clinical trials, and dictate if we can create a new SoC that treats the underlying autoimmunity as well as the symptoms it causes.