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Drugs in Developement


Indication: Type 1 Diabetes
Mode of Action: Inhibitor the Natural Killer (NK) receptor NKp46
Stage of Development: Pre-clinical
Patent Status: Patents granted or pending in the USA, Europe and Israel, 20 years expiration in 2030

BL-9020 Overview
BL-9020 is a novel antibody treatment for prevention of the development of Type 1 diabetes.  It was developed to treat Type 1 diabetes in early stage patients, during what is known as the "honeymoon period.” At this early stage of the disease, the insulin-producing pancreatic cells are not completely destroyed and continue to secrete insulin. Pre-clinical studies suggest that BL-9020 can preserve surviving cells, thus preventing full maturation of the disease.

BL-9020 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.

The inventors of BL-9020 have shown that NKp46 specifically recognizes pancreatic beta cells, leading to their destruction in both animal and human cells. These findings support NKp46 as an attractive target for anti-diabetes therapies and anti-NKp46 monoclonal antibodies as a new treatment modality for Type 1 diabetes. The inhibition of NK cells that are specifically targeted to the pancreas is a novel mechanism that could hopefully modify the course of the disease.

In January 2014, BioLineRx and JHL Biotech, a biopharmaceutical company that develops, manufactures, and commercializes biotherapeutics, have entered into an agreement to collaborate in the development and commercialization of BL-9020. Pursuant to the collaboration agreement, JHL Biotech will be responsible for all process development and manufacturing of BL-9020 during its pre-clinical and clinical development stages, and BioLineRx will be responsible for all pre-clinical development of BL-9020. Responsibility for clinical development of BL-9020 will be shared by the parties on a regional basis. Under the terms of the agreement, JHL Biotech will have global manufacturing rights to BL-9020, along with development and commercialization rights in China and Southeast Asia, and BioLineRx will have development and commercialization rights in the rest of the world. In all development and manufacturing of BL-9020, JHL Biotech will adhere to FDA guidelines and regulations. Each of JHL Biotech and BioLineRx will have rights to all development and regulatory data generated under the agreement in order to commercialize BL-9020 in its respective territory.

Pre-Clinical Data
Promising results of preclinical studies in a mouse model of Type 1 diabetes demonstrated that BL-9020 is able to inhibit the onset of diabetes. In the study only 40% of the mice treated with BL-9020 developed the disease, compared to 100% in the control group.

BL-9020 was invented by Professor Ofer Mandelboim from the Hebrew University of Jerusalem and Professor Angel Progador from Ben-Gurion University, together with Professor Yaakov Naparstek and Dr. Chamutal Gur from Hadassah Medical Center in Jerusalem.

BL-9020 is being developed by BioLineRx Ltd. under a worldwide exclusive license agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, B.G. Negev Technologies and Applications, and Hadasit Medical Research Services and Development.

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