BioLineRx announced Genentech, a member of the Roche Group, has filed a total of three regulatory submissions required to commence Phase 1b trials for BL-8040 in combination with atezolizumab (Tecentriq), Genentech's anti-PDL1 cancer immunotherapy, for the treatment of patients with solid tumors. The trials for pancreatic, gastric and non-small cell cancer are expected to commence during the second half of 2017, after receipt of regulatory approval.
These clinical studies are part of a cancer immunotherapy collaboration between BioLineRx and Genentech to conduct several Phase 1b studies investigating BL-8040 in combination with atezolizumab in multiple cancer indications, announced in September 2016. The Phase 1b studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters.
BL-8040, BioLineRx's lead oncology platform, is a CXCR4 antagonist that has been shown in clinical trials to be a robust mobilizer of immune cells and to be effective in inducing direct tumor cell death. Additional findings in the field of immuno-oncology suggest that CXCR4 antagonists may be effective in inducing the migration of anti-tumor T cells into the tumor micro-environment, as well as improving the infiltration of T cells into solid tumors. Atezolizumab is a humanized monoclonal antibody designed to bind to PD-L1 in tumor cells and tumor infiltrating immune cells and blocks interactions with the PD-1 and B7.1 receptors. Through this interaction, atezolizumab may enable the activation of T cells, whose migration into the tumor may be enhanced by BL-8040.
"The completion of all three regulatory submissions by our partner, Genentech, for the combination studies of our CXCR4 inhibitor lead oncology platform and their anti-PD-L1 immune checkpoint inhibitor, is a testimony to the commitment on the part of both companies to advance our collaboration and establish new treatments for the potential benefit of cancer patients,” Philip Serlin, Chief Executive Officer of BioLineRx said. “This follows our recently announced regulatory filing of the same combination for the treatment of AML patients. Our clinical collaboration with Genentech is advancing on track, and we look forward to the initiation of these multiple clinical studies."