Date: 2015-03-11
Type of information: Publication of results in a medical journal
phase: preclinical
Announcement: publication of results in Plos One
Company: BiolineRx (Israel)
Product: BL-9020
Action
mechanism: monoclonal antibody. BL-9020 is a first-in-class, monoclonal antibody which targets the Natural Killer (NK) receptor NKp46, which has been linked to Type 1 diabetes. Studies have shown that Natural Killer cells belonging to the innate immune system have a key role in the damage to pancreatic cells and, as a consequence, in the development of Type 1 diabetes. Professor Ofer Mandelboim from the Hebrew University of Jerusalem and Professor Angel Progador from Ben-Gurion University, the inventors of BL-9020, together with Professor Yaakov Naparstek and Dr. Chamutal Gur from Hadassah Medical Center in Jerusalem, found that the NKp46 receptor specifically recognizes pancreatic beta cells, leading to their destruction in both animal and human cells. These findings demonstrate the importance of the NKp46 receptor in diabetes development and emphasize the therapeutic potential of an anti-NKp46 monoclonal antibody as a new treatment modality for Type 1 diabetes. 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.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases - Autoimmune diseases
Country:
Trial details:
Latest
news: * On March 11, 2015, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, 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.
