A key monoclonal antibody clinically shown to play an important role in fighting juvenile diabetes, anti-CD3 targets an antigen expressed on T lymphocytes, the cells of the immune system that are responsible for the destruction of islet cells of the pancreas, and could slow the progression of the disease in children and adolescents.
A phase I clinical study of the antibody, showed that patients with recent-onset juvenile diabetes appeared to experience improved metabolic control and reduced reliance on insulin up to two years following a single course of treatment with a specific type of the anti-CD3 monoclonal antibody. A phase II clinical trial is planned to commence soon and will evaluate a multi-course study of the drug in patients with new onset diabetes.
Dr Scott Koenig, president and CEO of MacroGenics, commented on the agreement: “This is an exciting opportunity for patients, and for MacroGenics, as it represents a critical step toward the development and commercialization of an important molecule that has been shown to slow the progression of juvenile diabetes in early clinical studies.”
Koenig added that MacroGenics would additionally define the dose and regimen of the drug in clinical trials to create a final candidate with the best product profile.
The American Diabetes Association reports that approximately one in every 400 to 500 children and adolescents will develop type 1 diabetes. Diabetic patients are prone to a variety of complications, including heart disease, high blood pressure, blindness, and kidney disease. Accordingly, treatments that aim to slow the progression of the disease have the opportunity to substantially improve health and quality of life for these patients.