Clinical Program BL8040

Tel Aviv, Israel, September 20, 2016 - BioLineRx Ltd. (NASDAQ/TASE:BLRX) today 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 [...]

Study is part of strategic research collaboration between MSD and MD Anderson Cancer Center aimed to evaluate KEYTRUDA in selected GI tumors using various combinations

BL-8040 monotherapy resulted in increased infiltration of T cells into tumor. Data to be presented at the upcoming ASCO-GI conference; topline clinical results expected by H2 2018 as planned

Initiation of Phase 3 registrational study expected in second half of this year. Study to focus on stem cell mobilization for autologous transplantation in multiple myeloma patients

Results to date confirm that single injection of BL-8040 mobilizes sufficient amounts of cells required for allogeneic transplantation without need for G-CSF.

Genentech has submitted all three solid tumor trials planned under its cancer immunotherapy collaboration with BioLineRx. Studies will investigate the combination in pancreatic cancer, gastric cancer and non-small cell lung cancer (NSCLC)

Combination trial of BL-8040 and atezolizumab are part of initiative for the development of novel cancer immunotherapy combinations

BL-8040 in combination with high-dose Ara-C significantly improved overall survival compared to historical data

Study will assess mobilization of hematopoietic stem cells by BL-8040 compared to placebo, on top of G-CSF, for autologous transplantation in multiple myeloma patients