BioLineRx Ltd has announced the initiation of a Phase 2a trial investigating BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer. The Phase 2a study, named the COMBAT study, is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA in up to 30 subjects with metastatic pancreatic adenocarcinoma. The study is designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity.
The study will be conducted in the US, Israel and additional territories. In January 2016, BioLineRx entered into an immunotherapy collaboration with MSD, known as Merck in the US and Canada, to support a Phase 2a study investigating BioLineRx’s BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic cancer. BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells and to be effective at inducing direct tumor cell death.
Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumor T cells into the tumor. Therefore, when combined with KEYTRUDA, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells, BL-8040 has the potential to enable activated T cells to better reach tumor cells in the fight against pancreatic cancer.
Philip Serlin, Chief Financial and Operating Officer of BioLineRx, stated, "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.”
"Furthermore, we view BL-8040’s inhibition of CXCR4, which effects a change in the protective tumor micro-environment, as potentially synergistic with immune checkpoint inhibitors in additional oncological indications. To this end, as announced earlier this month, we have entered into a significant cancer immunotherapy collaboration with another global pharma company to support several Phase 1b studies investigating BL-8040 in combination with another immune check point inhibitor in multiple cancer indications. Upon completion of the expected multiple studies, under collaboration with these two world leaders in cancer immunotherapy, each of the parties will have the option to expand the collaboration to include pivotal registration studies,” added Mr. Serlin.