BioLineRx Receives European Patent Covering BL-8040 with Cytarabine for Acute Myeloid Leukemia

May 16, 2018

BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX), announced on 5/16/18 that the European Patent Office (EPO) has issued a Decision to Grant a patent claiming the use of BL-8040 with cytarabine, a chemotherapeutic agent, for the treatment of acute myeloid leukemia (AML).

This patent will be valid through March 2034, with the option of up to five years' patent term extension. Member patents were also granted in Japan and Hong Kong. Additional corresponding patent applications are pending in China (a Notice of Acceptance was received), Israel (a Notice of Acceptance was received), the United States, India, Korea, Mexico, Brazil, Canada and Australia.

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% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

"The long-term patent exclusivity we have received from the European Patent Office for BL-8040 in combination with cytarabine provides us with significant additional patent protection in AML, one of BL-8040's key indications," said Philip A. Serlin, Chief Executive Officer of BioLineRx. "In this regard, we are moving forward in full force with two ongoing trials in the AML space - a Phase 2b in consolidation AML and a Phase 1b/2 in maintenance AML, in addition to the continued follow-up on encouraging overall survival results shown in our recently completed relapsed/refractory AML study."

BL-8040 is also in trials for use in treating pancreatic cancer. Results from the phase Iia study are expected in the second half of 2018.

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