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BATTLE trial focuses on combo treatment for AML



A new clinical trial, known as the BATTLE study, will focus on the maintenance treatment of patients with intermediate and high-risk acute myeloid leukemia (AML) who have achieved a complete response (CR) following induction and consolidation therapy.

Up to 60 patients are planned to be enrolled in this multicenter, single arm, open-label Phase 1b/2 study to evaluate the relapse-free survival, minimal residual disease status, safety and tolerability of the combination of BL-8040, produced by BioLineRx Ltd., and atezolizumab, a cancer immunotherapy from Genentech. The study's primary endpoint is to assess whether the combination of BL-8040 and atezolizumab prolongs relapse free survival. In addition, the effect of the combination therapy on minimal residual disease, multiple immunological parameters and potential biomarkers will be evaluated.

BioLineRx’s CEO, Philip Serlin, said the companies are hopeful that combining atezolizumab with BL-8040 will demonstrate the potential for a new treatment for AML patients that extends the duration of remission following induction treatment — in particular for those for whom stem cell transplantation is inappropriate. The trial is planned to take place at approximately 22 sites in the U.S., Europe and Israel.

BL-8040, BioLineRx's lead oncology platform, is a CXCR4 antagonist that has been shown in a Phase 2a study in relapsed and refractory AML patients to be a robust mobilizer of immune and tumor cells and to be effective in inducing direct tumor cell death. These two effects, when combined with atezolizumab-induced blockade of the interaction between PD-L1 with PD-1 and B7.1, are hypothesized to have a beneficial effect on the minimal residual disease (MRD) status of AML patients. Specifically, this combined approach could potentially reduce an AML patient's MRD status from positive to negative and possibly have a favorable effect on disease outcome. This study's regimen aims at further prolonging the period of remission, exploring a novel maintenance approach to these patients.

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70 percent of human cancers and its expression often correlates with disease severity.

According to BioLineRx, in a number of clinical and pre-clinical studies BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells.

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