Israeli-based BioLineRx has started its Phase IIa COMBAT trial of BL-8040 in combination with KEYTRUDA (pembrolizumab) to treat metastatic pancreatic cancer.
BL-8040 is a short peptide designed to inhibit CXCR4, a chemokine receptor considered 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, which may affect both tumour and healthy cells.
The Phase IIa COMBAT trial has been designed as an open-label, multicentre, single-arm study intended to assess the safety, efficacy, tolerability and multiple pharmacodynamic parameters of the combination of BL-8040 and KEYTRUDA.
The study is a result of immunotherapy collaboration between BioLineRx and Merck and will involve 30 patients with metastatic pancreatic adenocarcinoma.
BioLineRx chief financial and operating officer Philip Serlin said: "We are looking forward to conducting this combination study of our lead oncology product and MSD's immune checkpoint inhibitor, which will be the first study of BL-8040 in the exciting and promising field of cancer immunotherapy.
“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."
Clinical and pre-clinical studies have validated the efficacy of BL-8040 in classifying cancer cells from the bone marrow and exposing them to chemo-based and bio-based anti-cancer therapy.
Image: Axial CT image displays macrocystic adenocarcinoma of the pancreatic head. Photo: courtesy of MBq.