BioLineRx has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent titled, ‘COMPOSITION OF BL-8040’, which covers the composition of motixafortide (APHEXDA/BL-8040).

The patent strengthens BioLineRx's robust intellectual property (IP) estate and extends its patent protection on motixafortide in the US through December 2041.

"We are very pleased to significantly strengthen our motixafortide IP with this key Composition of Matter patent that, among other things, extends our protection on this drug substance through December 2041," stated Philip Serlin, Chief Executive Officer of BioLineRx.

"We believe this allowance reflects the USPTO's acknowledgment of the unique attributes of motixafortide that make it a significant advancement among mobilization agents for multiple myeloma patients undergoing autologous stem cell transplantation, as well as the other high-need indications in which it is being investigated, including pancreatic cancer and gene therapies for patients with sickle cell disease (SCD)," Serlin added.

 In addition to a broad range of US and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation.

Additionally, motixafortide was granted five years of data exclusivity across all indications as a New Chemical Entity (NCE).

Motixafortide has also been granted Orphan Drug Designation in the US and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).