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Overview

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML and is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 2 study in stem cell mobilization for allogeneic transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which is expected to initiate a first-in-man study in the first half of 2018. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada), on the basis of which the Company has initiated a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA®; and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.

BioLineRx's close ties with universities, research institutes, academic institutions, technology transfer offices and biotechnology companies, both in Israel and globally, enable access to promising projects. The first stage involves a stringent screening and selection process. BioLineRx’s scientists specialize in evaluating potential drug candidates from both scientific and marketing perspectives. After acquiring the most promising projects, and depending on the phase of the project, the Company then performs feasibility assessment studies and development through pre-clinical and clinical stages. Supported and assisted by a distinguished panel of scientific advisers, the Company’s scientists and experts in pharmacy and regulation, clinical trials and IP work together to advance BioLineRx’s pipeline, usually through at least a Phase 2 proof of concept in humans. Finally, in most cases, the Company seeks to partner with medium size and large pharmaceutical companies to complete the clinical development and bring the product to market.

BioLineRx's pipeline currently consists of three main clinical stage therapeutic candidates:

BL-8040, a platform for multiple cancer and hematological indications: Phase 2a trial for relapsed/refractory acute myeloid leukemia (AML) successfully completed; Phase 2b trial ongoing as an AML consolidation treatment; Phase 2 trial in stem cell mobilization for allogeneic transplantation ongoing. 

AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant, anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on anti-metastatic immune response. Alpha-Gal is a cell-surface carbohydrate antigen which is not expressed by humans, unlike virtually all other mammals and bacteria. Therefore, humans universally produce and maintain high levels of anti-Gal antibodies, due to exposure to alpha-Gal on bacteria in the digestive system.

BL-5010, a novel formulation for the non-surgical removal of skin lesions, which was out-licensed to Omega Pharma for OTC indications in the territories of Europe, Australia and additional selected countries; CE mark has been received for first OTC indication and product launch initiated.

In addition, our pipeline includes several compounds at various stages of pre-clinical and clinical development.

BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates, a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA®, and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.