BioLineRx Ltd. has announced positive pre-clinical results for BL-9020, a novel monoclonal antibody for the treatment of Type 1 diabetes. The results were published on-line in PLoS One.
BL-9020 is a novel monoclonal antibody treatment designed to prevent immune-mediated destruction of insulin-producing beta cells in the pancreas. It was developed to treat Type 1 diabetes in early stage patients, during what is known as the "honeymoon period," where the pancreatic beta cells have not been completely destroyed and continue to secrete insulin.
BL-9020 targets NKp46, a unique target that is involved in the innate response against the pancreas. Pre-clinical studies in mouse models of Type 1 diabetes suggest that BL-9020 can inhibit beta cell death, thus preventing full maturation of the disease. This effect could significantly delay, and potentially prevent, the need for chronic insulin use by Type 1 diabetes patients, as well as provide a potential benefit in minimizing diabetes-related complications.
The new set of experiments shows that BL-9020 led to decreased levels of its target, NKp46, on murine NK cells, and specifically reduces the cytotoxic activity mediated by NKp46 in these cells. Consequently, BL-9020 significantly delayed the onset of diabetes and lowered the incidence of Type 1 diabetes in two different mouse models of diabetes.
After a single treatment of BL-9020, hyperglycemia was significantly less severe. Moreover, following a repeated long-term treatment regimen of pre-diabetic mice, 70% of mice treated with BL-9020 remained diabetes-free throughout the experiment (25 weeks), compared to only 30% of control-treated mice.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "We are greatly encouraged by these pre-clinical studies, showing that BL-9020 is able to delay the development of Type 1 diabetes in pre-diabetic mice. Type 1 diabetes is a highly prevalent autoimmune disease affecting millions around the world. Currently there is no cure for the disease, and patients with diabetes need to administer insulin on a daily basis throughout their lifetime. Many patients experience a "honeymoon period" following diagnosis which may last up to a year and can offer an opportunity for disease modifying therapies. Inhibiting the innate immune system, which has shown involvement in the destruction of the pancreas, is a novel approach for such treatment. In light of these promising pre-clinical results, we hope that BL-9020 will eventually be able to improve the quality of life for millions of children diagnosed with type 1 diabetes.”
As previously disclosed, in January 2014, BioLineRx entered into a collaboration agreement with JHL Biotech to collaborate in the development and commercialization of BL-9020.
Pursuant to the collaboration agreement, JHL Biotech is responsible for all process development and manufacturing of BL-9020 during its pre-clinical and clinical development stages, and BioLineRx is responsible for all pre-clinical development of BL-9020. Responsibility for clinical development of the product will be shared by the parties on a regional basis.