Israeli-based, clinical-stage biopharmaceutical company BioLineRx has agreed to collaborate with the University of Texas MD Anderson Cancer Center to conduct the Phase II trial for evaluation of BL-8040 in combination with Keytruda (pembrolizumab) to treat pancreatic cancer.
BL-8040 is developed as a short peptide and acts as a high-affinity antagonist for CXCR4, a chemokine receptor directly responsible for tumour progression, angiogenesis, metastasis and cell survival. Merck's humanised monoclonal antibody, Keytruda, boosts the body's immunity system to detect and fight tumour cells.
It resists PD-1 from interacting with its ligands, PD-L1 and PD-L2, subsequently activating T-lymphocytes that may affect both tumour and healthy cells.
The Phase II trial is designed as an open-label, single centre, single-arm study to determine the mechanism that will synergise both the drugs to treat pancreatic cancer.
The trial will also be focused on assessing the biological anti-tumour effects resulting from the combination of BL-8040 and Keytruda.
BioLineRx CEO Kinneret Savitsky said: "We believe that the combination of BL-8040 with Keytruda has the potential to expand the benefit of immunotherapy to cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer, which represent a significant unmet medical need.
"Furthermore, we view BL-8040's inhibition of CXCR4, which may affect the immunosuppressive tumour micro-environment, as potentially synergistic with immune checkpoint inhibitors in additional oncological indications."
The company is also planning to initiate another Phase IIa COMBAT study to assess the efficacy of BL-8040 in combination with Keytruda.
BioLineRx will conduct the study in collaboration with MSD Pharmaceuticals (Merck).