BioLineRx Ltd. (NASDAQ:BLRX) lost 0.049% in the previous session after hours of trading to close the day at $0.41.
The stock lost at the back of the company announcing that they had received Orphan Drug Designation for BL-8040 from the Food and Drug Administration for treatment of pancreatic cancer.
BL-8040 approved for cell mobilization and AML
The issuing of the Orphan Drug Designation by the FDA is a significant milestone for BioLineRx in the development of BL-8040. Philip Serlin, the BioLineRx CEO, indicated that the approval is an addition to the orphan designations that the company has received for BL-8040 in stem cell mobilization and AML.
Mr. Serlin stated that despite significant milestones that have been made in the development of treatment for cancers that have checkpoint inhibitors there is still significant unmet medical needs. Pancreatic cancer like most cancers is refractory to the treatment alternatives that have so far been advanced.
Collaborations for clinical evaluation of BL-8040
BioLineRx previously reported positive clinical data that supports the potential of the BL-8040 drug in an immunotherapy treatment combination for pancreatic cancer. The company expects to get results of their on-going pancreatic cancer clinical trials at the end of 2019. BL-8040 is currently under evaluation in clinical trials for the treatment of pancreatic cancer in two immunotherapy collaborations with Merck & Co and also with Roche Group member Genentech.
BL-8040 is a synthetic peptide that acts as a high-affinity antagonist to the CXCR4 receptor that causes progression of tumors, angiogenesis as well as the overall survival of cells. It has strong cell mobilization in cancer and immune cells as well as sensitization of cancer cells in bio-based and chemotherapies.
The Orphan Drug Designation of the BL-8040 entitles BioLineRx to have market exclusivity for a span of seven years to use the drug in the treatment of pancreatic cancer. The company will equally receive incentives for the development of the drug which includes FDA assistance for the design of clinical trials, tax credits as well as FDA-user free exemption.