Date: 2014-01-08
Type of information: Development agreement
Compound: BL-9020
Company: BioLineRx (Israel) JHL Biotech (Taïwan)
Therapeutic area: Metabolic diseases
Type agreement: development
commercialisation
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. The inhibition of NK cells that are specifically targeted to the pancreas is a novel mechanism with potential to modify the course of the disease.
Disease: type 1 diabetes
Details: * On January 8, 2014, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, and JHL Biotech, a biopharmaceutical company that develops, manufactures, and commercializes biologic medicines, have announced that they have entered into an agreement to collaborate in the development and commercialization of BL-9020, a novel monoclonal antibody for the treatment of Type 1 diabetes. 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 Chinanand 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. Each party will also be entitled to single-digit royalties on the sale of BL-9020 in the other party\'s respective territory.
Last October, BioLineRx has signed a worldwide, exclusive license agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, B.G. Negev Technologies and Applications Ltd., and Hadasit Medical Research Services and Development Ltd. for BioLineRx to develop and commercialize this monoclonal antibody, for the treatment of Type 1 diabetes.
Financial terms:
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