BioLineRx Announces In-Licensing of BL-9020, for Treatment of Type 1 Diabetes October 23, 2013, 7:07 a.m. ET Preclinical data show that BL-9020 prevents formation of Type 1 diabetes JERUSALEM, Oct. 23, 2013 /PRNewswire/ -- BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that it 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 BL-9020, for the treatment of Type 1 diabetes. 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. Previously, the project was developed under BioLineRx's Early Development Program as EDP-10. 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. "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," said Professor Moshe Phillip, M.D., Director of the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes at Schneider Children's Medical Center in Israel, and Vice President of Medical Affairs at BioLineRx. "Oftentimes, when the disease is diagnosed, patients experience a "honeymoon period" which may last up to a year, during which there are still some insulin producing cells in the pancreas. If the disease could be slowed down or halted at this stage, it would be a significant step towards curing diabetes, and will definitely improve the quality of life for millions." Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "The results of the pre-clinical studies were extremely convincing, and raise hopes that BL-9020 can be an effective treatment that will prevent the development of diabetes. In the study, which was performed on a mouse model for diabetes, only 40% of the mice treated with BL-9020 developed the disease, compared to 100% in the control group. Therefore, we have high hopes that BL-9020 will be an effective treatment for preventing or delaying full development of the disease in humans. "Due to its unique mechanism of action, promising in vivo results and the true unmet medical need, this project, although still in pre-clinical stages of development, is already under discussion with a number of potential optimization and manufacturing co-development partners. We believe the co-development approach is the most effective for us in the unique development of antibodies," concluded Dr. Savitsky.
About BL-9020 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. 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 receptor NKp46 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.
About Type 1 Diabetes Type 1 diabetes, which usually appears in children and adolescents, results from auto-immune destruction of the pancreatic beta cells producing insulin. This leads to a pathological, high level of sugar in the blood and urine. Treatment of type 1 diabetes is currently limited to life-time administration of insulin, usually by injection. The disease affects over 20 million people worldwide, and in 2012 the Type 1 diabetes market was estimated at over $3.5 billion.
About BioLineRx BioLineRx is a publicly-traded biopharmaceutical development company dedicated to building a portfolio of products for unmet medical needs, as well as those with advantages over currently available therapies. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization. BioLineRx's current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc. and is in the midst of a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions, which is expected to commence a pivotal CE-mark registration trial in late 2013; BL-8040 for treating acute myeloid leukemia (AML) and other hematological cancers, which is in the midst of a Phase 2 study; and BL-7010 for celiac disease, which is expected to commence a Phase 1/2 study in late 2013.
BioLineRx 和喜康生物共同開發抗 I 型糖尿病單抗體藥物 喜康生物將獲得此藥物（BL-9020）在中國地區以及東南亞地區的開發和商業化許可權 2014 年 1 月 8 日，以色列耶路撒冷----台灣新竹聯合發布：BioLineRx 一家專注於臨床藥物研究、藥物注冊、新型藥物品種開發的生物醫藥公司，與喜康生物，一家專注於蛋白質藥物之製程開發與生產服務的公司，今天共同宣布簽署戰略合作協議，兩家公司達成共識，將在全球范圍內開展新型藥物 BL-9020 的研發以及商業化工作。BL-9020 是一種 I 型糖尿病的標靶單克隆抗體藥物。 依照協議內容，喜康生物主要負責 BL-9020 藥物臨床前、臨床研發階段的藥物開發和商業化生產工作。BioLineRx 公司將負責 BL-9020 藥物的所有臨床前研發工作。BL-9020 的臨床研發工作將由協議雙發按區域分配共同完成。 BL-9020 是一種新型的單克隆抗體藥物，該藥物能夠用於阻止胰腺β細胞的破壞。BL-9020 主要針對 I 型糖尿病的發病初期，在該階段，胰腺β細胞沒有被完全破壞，還具有分泌胰島素的功能。臨床前研究表明，在患有 I 型糖尿病的老鼠體內注入 BL-9020，能夠保護胰腺β細胞，進而推遲或阻止 I 型糖尿病的發生。這種藥物作用，能使 I 型糖尿病患者減少胰島素用量，甚至停止胰島素的使用。 依照協議內容，喜康生物將享有 BL-9020 藥物在中國以及東南亞地區的發展和商業化權利﹔BioLineRx 公司將享有全球其他范圍內的發展和商業化權利。協議規定，協議雙方在各自的授權范圍內，實施 BL-9020 的研發和商業化進程時，均有權利對協議產生的數據進行監管。每一方亦有權以個位數的特許權使用費，在對方區域內銷售 BL-9020。 BioLineRx 首席執行官 kinneretSavitsky 博士說："我們非常高興能夠和喜康生物形成策略性的合作關系，喜康生物是中國生物醫藥領域的一顆新星。喜康生物擁有一支世界領先的技術團隊，團隊成員在生物藥物研發以及商業化生產方面具有深厚的經驗，同時喜康生物在全球還擁有很多合作伙伴。我們雙方將建立起長遠的策略合作關系，我們希望能以此次合作項目為基礎，雙方能在更多的項目領域建立合作關系。" KinneretSavitsky 博士指出: I型糖尿病是一種普遍存在的自身免疫性疾病，在全球范圍內有數以百萬的患者，目前還沒有有效的治療方法。I 型糖尿病患者每天需要注射胰島素維持生命。通常情況下，在 I 型糖尿病的發病初期，有一個"蜜月期"，在該階段，胰腺β細胞沒有被完全破壞，還能分泌少量胰島素，通常該階段能維持一年左右。我們目前臨床前實驗結果表明，BL-9020 能在很大程度上延長"蜜月期"，或者使 I 型糖尿病停留著這個階段，這將是治療 I 型糖尿病的一個關鍵性的進步" 喜康生物首席執行官喬石瑞先生介紹說："中國糖尿病現狀非常嚴峻，中國擁有 1 億的糖尿病患者，並且這個數據將在 2035 年達到 1.5 億，從而使中國成為最大的糖尿病藥物市場。在所有的糖尿病患者中，I 型糖尿病患者佔據 5-10%，I 型糖尿病主要在兒童期確診，一經確診，患者一生都將受到這種慢性疾病的困擾。我們相信，BioLineRx 公司新型預防 I 型糖尿病藥物將能夠改善患者的身體狀況，為中國以及東南亞國家的患者帶來福音。" 喬石瑞先生指出："以色列是全球創新技術中心，我們希望與 BioLineRx 的合作關系能擴展的其他領域，並且希望通過這種合作關系來實現喜康生物的願景-----為全球患者提供高品質、可負擔的生物藥物。"
關於 BL-9020 BL-9020 是靶向與 I 型糖尿病相關的自然殺傷細胞受體 NKp46 的一種一級單克隆抗體。研究結果表明屬於先天免疫系統的自然殺傷類細胞（Natural Killer Cell, NK Cell)對胰島細胞具有一定的破壞作用，因此可導致 I 型糖尿病的發生。來自耶路撒冷希伯來大學的OferMandelboim 教授與 BL-9020 的發明者來自班古裡昂大學的 Angel Progador 教授以及來自耶路撒冷漢德森醫學中心的 Yaakov Naparstek 教授和ChamutalGur 博士合作發現：在實驗動物及人體中，NKp46 受體特異性地識別並破壞胰島 beta 細胞。該發現不僅闡明了 NKp46 受體在糖尿病發生中的重要作用，同時也揭示了抗 NKp46 單克隆抗體具有成為治療 I 型糖尿病的藥物潛力。通過抑制特異性地作用於胰島細胞的自然殺傷細胞(NK cells)來治療糖尿病是一種全新的醫療機制，具有成為疾病治療的新突破的潛力。
The Role of Natural Cytotoxicity Receptors in Various Pathologies: Emphasis on Type I Diabetes. Front Immunol. 2014 Jan 20;5:4. Natural killer (NK) cells are innate immune lymphocytes that function mainly as immune sentinels against viral infection and tumorigenesis. NK cell function is governed by inhibitory and activating signals arising from corresponding receptors. A prominent group of activating NK receptors is the natural cytotoxicity receptors (NCRs), which includes NKp30, NKp44, and NKp46. These receptors bind various diverse ligands of pathogenic, tumor, and even self origin. Type 1 diabetes mellitus (T1D) is a multifactorial autoimmune disease, in which insulin-producing beta (β) cells are ablated by the immune system. This killing of β cells is carried out mainly by T cells, but many other immune cells have been implicated in the pathogenesis of this disease. Importantly, NK cells were shown to be key participants in the initial autoimmune attack. It was shown that all β cells from humans and mice, healthy or sick, express an unknown ligand for the activating NKp46 receptor. In this review, we describe the role played by the NCRs in various pathologies with an emphasis on Type I diabetes.
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