BioLineRX, Merck to study drug combination for treatment of pancreatic cancer

The companies will partner in a phase 2 study to evaluate the safety and efficacy of the combination of BioLineRx’s BL-8040 CXCR4 antagonist and Merck’s Keytruda humanized monoclonal antibody in patients with metastatic pancreatic adenocarcinoma.

BioLineRx will sponsor and carry out the study, which is expected to start by mid-2016. The companies have the option to expand the collaboration into a pivotal late-stage trial.

BL-8040 functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival.

It has been demonstrated in various clinical trials to mobilize immune cells and to be effective at inducing direct tumor cell death.

Keytruda increases the ability of the body’s immune system to fight tumor cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.

It activates T lymphocytes which may affect both tumor cells and healthy cells.

BioLineRx CEO Kinneret Savitsky said: "Because certain tumors exhibit only a modest response to existing immunotherapies, we are increasingly seeing clinical studies involving combinations of immuno-oncology agents with other classes of drugs.

"We are initiating this study with the hope that it will show 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 represents a significant unmet medical need."