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BCRX. BioLineRx Ltd. (BLRX)

Highlights and achievements in 2017 and to date:

Continued progress and execution according to plan on multiple clinical trials for the Company's lead oncology program, BL-8040:
•Initiation of pivotal Phase 3 GENESIS study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation, following successful meeting with the FDA earlier in the year;
•Partial monotherapy results from Phase 2a COMBAT study, investigating the combination of BL-8040 and Merck's PD-1 inhibitor, Keytruda® (pembrolizumab), in pancreatic cancer, showed significantly increased infiltration of T cells into the tumor, as well as robust mobilization of immune cells;
•Initiation of three Phase 1b/2 studies under collaboration with Genentech, exploring the combination of BL-8040 with Tecentriq® (atezolizumab), Genentech's anti-PD-L1 cancer immunotherapy agent;
•Overall long-term survival results in Phase 2a trial in relapsed/refractory AML demonstrated that the combination of BL-8040 with high-dose Ara-C (HiDAC) significantly improved overall survival, compared with historical data of HiDAC monotherapy;
•Partial results of Phase 2 study for BL-8040 as novel stem cell mobilization treatment for allogeneic bone-marrow transplantation support BL-8040 as a one-day dosing regimen for rapid mobilization of stem cells.

The Company also announced progress in expanding and accelerating its growth potential and strengthening its balance sheet:
•Acquired Agalimmune Ltd., a UK-based biopharmaceutical company developing cancer immunotherapy treatments, thereby broadening BioLineRx's position in the immuno-oncology field with a second novel lead compound, AGI-134. Pre-clinical data presented at ASCO-SITC showed complete tumor regression in the majority of mice treated with AGI-134;
•Completed underwritten public offering of American Depository Shares for gross proceeds of $28.9 million led by BVF Partners, L.P; the Company also received an additional $9.6 million direct investment from BVF Partners.

Expected significant upcoming milestones for 2018:


•Top-line results in immuno-oncology Phase 2a COMBAT study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA, expected in H2 2018;
•Results from the lead-in stage of the Phase 3 GENESIS study in stem-cell mobilization, expected in H2 2018;
•Initiation of Phase 1b/2 immuno-oncology study for BL-8040 in combination with Genentech's atezolizumab for non-small cell lung cancer. Partial results in Phase 1b/2 trials under collaboration with Genentech expected in H2 2018;
•Initiation of Phase 1/2a immuno-oncology study for AGI-134 in several solid tumor indications expected in mid-2018;
•Top-line results of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by mid-2018.



https://ih.advfn.com/p.php?pid=nmona&article=76873656

Form 20-F
https://www.sec.gov/Archives/edgar/data/1498403/000117891318000765/zk1821295.htm

http://www.biolinerx.com/