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BioLineRx gets US patent covering use of BL-8040 in immunotherapy

Israel-based clinical-stage biopharmaceutical firm BioLineRx has announced that an Issue of Notification has been received from the US Patent and Trademark Office (USPTO) for US Patent No. 8,663,651.

The patent includes claims to protect the use of a clinical-stage drug candidate BL-8040’s composition for improving immune responses to an antigen, such as a tumor-associated antigen.

The issued patent has a term extending to October 2029 and is part of BL-8040’s expanding patent portfolio, which includes 13 issued patents and 25 patent applications pending worldwide, providing a strong intellectual property estate around BL-8040.

BioLineRx chief executive officer Kinneret Savitsky said the company is happy with this newly issued patent for BL-8040, which further strengthens the patent position it has for its leading oncology program.

"We view BL-8040 as a platform for multiple oncological and hematological indications, and robust patent protection provides us with the foundation to pursue these multiple indications for the BL-8040 platform," Savitsky said.

"BL-8040 is currently undergoing a Phase 2 trial for the treatment of acute myeloid leukemia and is expected to enter a Phase 1 trial for stem cell mobilization in the 2nd quarter of 2014.
"We expect top-line results for both of these clinical studies towards the end of the year or early next year."

BL-8040, which is a short peptide that functions as a high-affinity antagonist for CXCR4, is indicated for the treatment of acute myeloid leukemia, as well as other hematological indications.

CXCR4 is a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival.

It is over-expressed in over 70% of human cancers and its expression often correlates with disease severity.

Currently, BL-8040 is undergoing Phase II trial for acute myeloid leukemia (AML) and is expected to start Phase I trial in stem cell mobilization in the second quarter of 2014.