BioLineRx Ltd. has announced the signing of a collaboration agreement with The University of Texas MD Anderson Cancer Center for the investigation of BL-8040 in combination with KEYTRUDA® (pembrolizumab) in pancreatic cancer. The study will be conducted as an investigator-sponsored study, as part of a strategic clinical research collaboration between MSD (known as Merck in the US and Canada) and MD Anderson Cancer Center aimed at evaluating Merck's anti-PD-1 therapy, KEYTRUDA, in combination with various treatments and novel drugs.
The open-label, single center, single-arm Phase 2 study aims to evaluate the potential of BL-8040 with KEYTRUDA in pancreatic cancer and will focus on the mechanism of action by which both drugs might synergize. In addition to assessing clinical response, the study will include multiple assessments to evaluate the biological anti-tumor effects induced by the combination. BioLineRx will supply BL-8040 for the study, which is expected to commence later this year.
In June 2016, the Company announced the filing of the regulatory submissions required tocommence a separate Phase 2a study focusing on evaluating the clinical efficacy of BL-8040 in combination with KEYTRUDA, also for the treatment of patients with pancreatic cancer. This trial, named the COMBAT study, will be conducted under a collaboration agreement between BioLineRx and MSD announced in January 2016. The study is expected to commence shortly after receipt of regulatory approval, anticipated in the third quarter of 2016.
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, BL-8040 has the potential to enable activated T cells to better reach tumor cells in the fight against pancreatic cancer.
"We are very excited that MSD and MD Anderson Cancer Center selected BL-8040 to be tested under their collaboration. This will be the second study planned for investigating the combination of BL-8040 and KEYTRUDA, which further validates the potential of combining the two for the treatment of metastatic pancreatic cancer patients," said Kinneret Savitsky, Ph.D., Chief Executive Officer of BioLineRx.
"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 may affect the immunosuppressive tumor micro-environment, as potentially synergistic with immune checkpoint inhibitors in additional oncological indications."