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Agreements

Date: 2016-09-07

Type of information: Clinical research agreement

Compound: BL-8040 and atezolizumab

Company: BiolineRx (Israel) Genentech, a member of Roche Group (USA - CA - Switzerland)

Therapeutic area: Cancer - Oncology

Type agreement:

clinical research

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor/peptide. BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

Anti-PDL1 antibody MPDL3280A (atezolizumab) is an investigational monoclonal antibody designed to make cancer cells more vulnerable to the body’s immune system by interfering with a protein called PD-L1. PD-L1 is found on the surface of cells in tumours and is believed to act as a “stop sign,” preventing the immune system from destroying cancer cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells. MPDL3280A is being studied in clinical trials to understand whether blocking PD-L1 will help the immune system respond to cancer.  

By inhibiting PD-L1, atezolizumab may enable the activation of T cells, whose migration into the tumor may be enhanced by BL-8040.

Disease: acute myeloid leukemia (AML), solid tumors

Details:

* On September 7, 2016, BioLineRx announced that it has entered into a collaboration with Genentech, a member of the Roche Group, to support several Phase 1b studies investigating BioLineRx's BL-8040 in combination with atezolizumab, Genentech's anti-PDL1 cancer immunotherapy, in multiple cancer indications. The Phase 1b studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters, in hematologic malignancies and solid tumors.

Under the agreement, Genentech will sponsor and conduct several Phase 1b trials in multiple solid cancer indications. In addition, BioLineRx will sponsor and conduct a Phase 1b study in acute myeloid leukemia (AML) patients. The studies are planned as open-label, multicenter, single-arm trials designed to evaluate the safety and efficacy of the combination of BL-8040 and Atezolizumab. Upon completion of the studies, both parties will have the option to expand the collaboration to include a pivotal registration study. Additional details of the collaboration were not disclosed.

 

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