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.
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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.
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By GlobalDataBioLineRx 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.
