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SEC filings
BIOLINERX LTD. filed this Form 6-K on 09/26/2017
Entire Document

Exhibit 1

For immediate release
BioLineRx Announces Initiation of Phase 1b/2 Trial for BL-8040
in AML Under Immunotherapy Collaboration
- The BATTLE trial will investigate the combination of BL-8040 and
atezolizumab under cancer immunotherapy collaboration -
Tel Aviv, Israel, September 26, 2017 - BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today the initiation of a Phase 1b/2 trial for BL-8040 in combination with atezolizumab (TECENTRIQ®), an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche Group. The trial, known as the BATTLE study (NCT03154827), 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 study, to evaluate the relapse-free survival, minimal residual disease status, safety and tolerability of the combination of BL-8040 and atezolizumab for maintenance treatment in AML patients. 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. The trial is planned to take place at approximately 22 sites in the US, Europe and Israel.

The BATTLE study is part of BioLineRx’s cancer immunotherapy collaboration with Genentech to conduct several Phase 1b/2 studies investigating the combination of BL-8040 with atezolizumab in multiple cancer indications, announced in September 2016.

Philip Serlin, Chief Executive Officer of BioLineRx, stated, “We are excited to commence yet another clinical study under this significant immuno-oncology collaboration, following the recent initiation of a study to evaluate the combination of the same two drugs for the treatment of pancreatic cancer. The BATTLE study is the first study under our collaboration in hematologic malignancies, and we are hopeful that combining atezolizumab with BL-8040 will demonstrate the potential to establish a new treatment for AML patients that would extend the duration of remission following induction treatment, in particular for patients for whom stem-cell transplantation is inappropriate. We look forward to the initiation of additional combination studies under this collaboration, all planned by the end of this year.”