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Stocks On The Run: BioLineRx Ltd. (NASDAQ/TASE: BLRX)

BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, declared recently that Genentech, a member of the Roche Group, has begind a Phase 1b/2 study for BL-8040 in combination with atezolizumab (TECENTRIQ®), Genentech’s anti-PDL1 cancer immunotherapy agent, evaluating the combination in metastatic pancreatic ductal adenocarcinoma.
Up to 40 patients are planned to be enrolled in this Phase 1b/2, multicenter, randomized, controlled, open-label study to evaluate the clinical response, safety and tolerability, in addition to multiple pharmacodynamic parameters, of BL-8040 in combination with atezolizumab. At First, patients will receive BL-8040 injections as priming monotherapy for five successive days, after which, from day 8, they will receive both BL-8040 and atezolizumab, and continue with multiple treatment cycles for up to two years or until disease progression, clinical deterioration or unacceptable toxicity.
The clinical study partnershipbetween BioLineRx and Genentech, a member of the Roche Group, is part of MORPHEUS, Roche’s Novel Cancer Immunotherapy Development Platform. MORPHEUS is a phase 1b/2 adaptive platform to assess the efficacy and safety of combination cancer immunotherapies.
Philip Serlin, Chief Executive Officer of BioLineRx, stated, “We are very happy with the launch of the first clinical study under our cancer immunotherapy partnershipwith Genentech. Pancreatic cancer is a very difficult cancer to treat, and both conventional chemotherapy and immunotherapy have failed to demonstrate a noteworthybenefit for these patients. BL-8040 has been shown to have robust mobilization of immune cells, improve the infiltration of T cells into solid tumors, and affect the immunosuppressive tumor micro-environment. We are therefore hopeful that combining atezolizumab with BL-8040 can lead to a noteworthyadvancement in the treatment of pancreatic cancer, and of other solid tumors that are difficult to treat. We look forward to the initiation of additional combination studies under this collaboration, all planned for the second half of this year.”
BioLineRx is carrying out a larger cancer immunotherapy partnershipwith Genentech to conduct several Phase 1b/2 studies investigating BL-8040 in combination with atezolizumab in multiple cancer indications, declared in September 2016.
BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in clinical trials to be a robust mobilizer of immune cells and to be effective in inducing direct tumor cell death. Additional findings suggest that BL-8040 may be effective in inducing the migration of anti-tumor T cells into the tumor micro-environment, in addition to improving the infiltration of T cells into solid tumors. Atezolizumab is a humanized monoclonal antibody designed to bind to PD-L1 in tumor cells and tumor infiltrating immune cells and blocks interactions with the PD-1 and B7.1 receptors. Through this interaction, atezolizumab may facilitate the activation of T cells, whose migration into the tumor may be improved by BL-8040.

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