Pharmaceutical Business review

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

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.