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January 16, 2017

BioLineRx begins Phase IIa trial of BL-8040 combined with KEYTRUDA to treat metastatic pancreatic cancer

Clinical-stage bio-pharmaceutical company BioLineRx has begun its second Phase 2a trial investigating BL-8040 in combination with KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy, in patients suffering with metastatic pancreatic cancer.

Clinical-stage bio-pharmaceutical company BioLineRx has begun its second Phase 2a trial investigating BL-8040 in combination with KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy, in patients suffering with metastatic pancreatic cancer.

The trial is part of a research collaboration between MSD and MD Anderson Cancer Center.

The Phase 2a study is open-label, single-centre and single-arm, and intends to analyse the potential of BL-8040 in combination with KEYTRUDA in pancreatic cancer and focuses on the mechanism-of-action, by which both drugs might synergise.

In addition to assessing clinical response, the trial includes multiple assessments to analyse the biological anti-tumour effects induced by the combination.

Last August, the firm 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 in pancreatic cancer.

The investigator-sponsored study is part of a strategic, immuno-oncology, clinical research collaboration between MSD, known as Merck in the US and Canada, and MD Anderson Cancer Center, and is aimed at evaluating Merck's anti-PD-1 therapy, KEYTRUDA, in combination with various treatments and novel drugs.

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"We believe that the trial announced today will support the COMBAT study and deepen our understanding of the mechanism-of-action of the combination treatment."

BioLineRx CEO Philip Serlin said: "This is the second Phase 2 immuno-oncology trial taking place to investigate the combination of BL-8040 and KEYTRUDA for the treatment of pancreatic cancer.

"In September 2016, we announced the initiation of the COMBAT study, our first Phase 2a study for evaluating the clinical efficacy of BL-8040 in combination with KEYTRUDA, also for the treatment of patients with pancreatic cancer.

"The COMBAT study, which is being conducted by BioLineRx under a collaboration agreement between BioLineRx and MSD is also currently recruiting patients. We believe that the trial announced today will support the COMBAT study and deepen our understanding of the mechanism-of-action of the combination treatment.

"We also believe that the combination of BL-8040 with KEYTRUDA has the potential to expand the benefit of immunotherapy to non-respondent patients and cancer types currently resistant to immuno-oncology treatments, such as pancreatic cancer.

"Furthermore, BL-8040's inhibition of CXCR4, which may affect the immunosuppressive tumor micro-environment, is potentially synergistic with immune checkpoint inhibitors in additional oncological indications."

BL-8040, BioLineRx's lead oncology platform, is a CXCR4 antagonist that has indicated in several clinical trials to be a strong mobiliser of immune cells and to be effective at inducing direct tumour cell death.

Further findings in the field of immuno-oncology indicate that CXCR4 antagonists may be effective in inducing the infiltration of anti-tumour T-cells into the tumour. Hence, 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 allow activated T-cells to better reach tumour cells.

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