Immunotherapy is a powerful weapon against cancer during the long-lasting anti-cancer battle. And recently, it was found to be also applicable to diabetes, another important chronic disease that tortures a large population.

During the American Diabetes Association (ADA) 79th Scientific Sessions held in San Francisco this June, an important study showed for the first time that the incidence of type 1 diabetes can be delayed by two years or more through preventive immunotherapy treatment. The findings were also published online in the New England Journal of Medicine.

Type 1 diabetes is a chronic autoimmune disease, and the wrong attack of T cells leads to impaired islet beta cell function, and patients need to rely on exogenous insulin therapy. Among the population that are genetically susceptible to type 1 diabetes, it has been observed that the disease actually begun to develop before the onset of hyperglycemia, mainly due to the appearance of autoantibodies and abnormal glucose tolerance. At present, there are no effective prevention measures among the high-risk populations.

Teplizumab is a CD3 monoclonal antibody drug that targets T cells and protects beta cells. Previous clinical studies have found that teplizumab is effective in slowing beta cell damage in patients with newly diagnosed type 1 diabetes. The study's lead author, Dr. Kevan C. Herold of Yale University, said, "This drug has not been tested in a non-patient population, and we hope to understand whether early intervention using teplizumab can benefit people at high risk for type 1 diabetes."

This phase 2, randomized, placebo-controlled, double-blind trial was sponsored by the National Institutes of Health and was conducted by an international scientific organization called Type 1 Diabetes TrialNet.

The study included 76 subjects aged 8-49 years, of whom 55 (72%) were adolescents below 18 years old. These subjects are all at high risk of diabetes because they have a family history of type 1 diabetes. Besides, they already have at least two autoantibodies associated with diabetes, and have developed impaired glucose tolerance. Subjects were randomized to receive 14-day teplizumab (44 patients) or placebo (32 patients). All subjects received a glucose tolerance test every 6 months until the end of the study or until they developed type 1 diabetes.

The median time to progression to type 1 diabetes was 24.4 months in the control group and 48.4 months in the teplizumab treatment group. 72% of the control group were diagnosed with type 1 diabetes, compared with 43% of the teplizumab group. Statistics showed that teplizumab reduced the risk of type 1 diabetes by 59% (HR=0.41; 95% CI, 0.22 - 0.78; P= 0.006).

The researchers found that the efficacy of teplizumab was most pronounced in the first year after administration. At the same time, many factors, including age, may affect the preventive effect of teplizumab, which is associated with faster development of type 1 diabetes in adults and adolescents.

Dr. Lisa Spain, a project scientist at the NIH Institute for Diabetes, Digestive and Kidney Diseases (NIDDK), said: "The difference between the two groups is very impressive. This is the first time we have demonstrated that prophylaxis can delay the onset of type 1 diabetes. This result is important for people, especially young people with a family history, who can benefit from early screening and treatment."

In terms of safety, the side effects of teplizumab are similar to those previously seen in patients with newly diagnosed type 1 diabetes, including rashes and decreased lymphocyte counts in the short term.

This result is undoubtedly encouraging, but the researchers also said that it is necessary to expand the subject to a larger population so as to understand the effect of teplizumab in a wider range of high-risk groups. In addition, the mechanism of action, long-term efficacy and safety of the drug need to be further confirmed.

This finding is definitely exciting as our biological research on type 1 diabetes has been around for decades and finally brings a potential treatment that can really benefit people.

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Reference:

[1] Kevan C. Herold, et al., (2019). An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med, 10.1056/NEJMoa1902226

[2] Drug delays type 1 diabetes in people at high risk. Retrieved Jun 10, 2019, from https://www.eurekalert.org/pub_releases/2019-06/niod-ddt060619.php