SECURITIES AND EXCHANGE COMMISSION
 
WASHINGTON, D.C. 20549
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
 
For the month of June 2017
_______________________
 
BioLineRx Ltd.
(Translation of registrant's name into English)
_______________________
 
2 HaMa'ayan Street
Modi'in 7177871, Israel
 (Address of Principal Executive Offices)
_______________________
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:        
 
Form 20-F ☑          Form 40-F ☐
 
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:          
 
Yes           No ☑
 

The registrant hereby files as Exhibit 1 to this Report on Form 6-K its new corporate presentation which contains, among other things, disclosures regarding the registrant's planned phase 3 registrational study for the use of BL-8040 in autologous stem cell mobilization.
 
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933.
 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
  BioLineRx Ltd.  
       
 
By:
/s/ Philip Serlin  
    Philip Serlin  
    Chief Executive Officer  
       
Dated: June 12, 2017
 

 

 
Exhibit 1

 Corporate PresentationJune 2017 
 

 Forward-Looking Statements  This presentation contains “forward-looking statements.” These statements include words like “may,” “expects,” “believes,” “plans,” “scheduled,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  
 

 Drug development company focused on oncology & immunology:BL-8040 (CXCR4 antagonist) with robust clinical program in immuno-oncology, AML and bone marrow transplantationAGI-134 (alpha-Gal immunotherapy) activating a patient-specific, anti-tumor response to patient’s own cancer neo-antigensImmunology/fibrosis franchise under collaboration with Novartis PharmaSignificant collaborations with leading pharma companiesStrategic collaboration with Novartis for joint development of innovative assetsImmunotherapy collaboration with Genentech in multiple oncology indications (BL-8040 & Atezolizumab)Immunotherapy collaboration with Merck in pancreatic cancer (BL-8040 & Keytruda)  BioLineRx Snapshot 
 

       OTHER              Main Pipeline Assets  PROJECT    INDICATION      PARTNERS  PRE-CLINICAL  PHASE 1  PHASE 2  PHASE 3  REGULATORY APPROVAL  CANCER  IMMUNOLOGY  Consolidation AML  Maintenance AML  Gastric cancer  Non-small cell lung cancer  Pancreatic cancer  Pancreatic cancer  Stem-cell mobilization    Type 1 diabetes  NASH  Liver failure diseasesDry eye syndrome  BL-8040  BL-9020  BL-1210  BL-5010                    Regional out-license to Perrigo  Developed under strategic collaboration with Novartis  Collaboration with JHL for China and Southeast Asia  Immunotherapy collaboration with Merck (Pembrolizumab)  Immunotherapy collaboration with Genentech (Atezolizumab)            Skin Lesions    Developed under strategic collaboration with Novartis    BL-1220  BL-1230    Developed under strategic collaboration with Novartis  AGI-134  Solid tumors   
 

 BL-8040  Best-in-class CXCR4 antagonist for multiple oncology indications 
 

 BL-8040 Highlights  Best-in-class CXCR4 antagonistPlatform molecule with MOA relevant in multiple tumorsMost advanced compound targeting CXCR4Partnerships with leading companies and institutions (Genentech, Merck, MDACC)Multiple clinical studies ongoing or in final planning stagesMultiple studies under immunotherapy partnerships with Genentech and MerckData readouts in 2017 and 2018Large phase 2b study in AML consolidation treatment line running at full steamData readout in H2 2019; potential interim analysis in H2 2018Initiation of phase 3 registrational study in autologous SCM planned for H2 2017Received Orphan Designation from FDA for AML & SCMPotential for multiple phase 3 studies under immunotherapy partnerships 
 

 BL-8040 Clinical Development Program   Pre-Clinical  Phase 1  Phase 2  Phase 3  INDICATION  STUDY          ONGOING  PLANNED  AML Consolidation  ACUTE MYELOID LEUKEMIA (AML)  AML Maintenance (Atezolizumab)  BLAST  BATTLE    H2/2017 initiation – Genentech collab  Immunotherapy Combination   Pancreatic (Pembrolizumab)  COMBAT  Merck collab  MORPHEUS  Pancreatic (Atezolizumab)  H2/2017 initiation – Genentech collab  MORPHEUS  Gastric (Atezolizumab)  H2/2017 initiation – Genentech collab  MORPHEUS  NSCLC (Atezolizumab)  H2/2017 initiation – Genentech collab  STEM CELL MOBILIZATION  BL-8040.07  SCM as Single Agent (Allogeneic)    GENESIS  SCM (Autologous)  H2/2017 initiation  Pancreatic (Pembrolizumab)  BL-8040.11  MDACC collab 
 

 BL-8040 in Immuno-Oncology   
 

 BL-8040’s MoA in Cancer Immunotherapy  Immunostimulant - BL-8040 is a powerful mobilizer of immune cells from the bone marrow and lymph nodes (T-cells, B-cells, immature dendritic-cells and NK-cells)Potentiator - BL-8040 increases infiltration of immune cells into tumors (exhibiting a synergistic effect with anti PD1/PD-L1 immune checkpoint inhibitors)Microenvironment modifier - BL-8040 affects the tumor microenvironment by decreasing CXCR4-mediated migration of immune suppressor cells (i.e. MDSCs, Tregs)                                                                                                                                                      PD-L1/PD1  CXCR4  SDF1  Immunosuppressive cells  Tregs  CD8+ CTL                                                                                                                                                                                                BL-8040                                                                                                                                      PD1 Ab                            PD-L1 Ab    PD1 or PD-L1 Ab.  BL-8040 
 

 BL-8040 is a Powerful Mobilizer of Immune Cells(clinical data)  BL-8040  CD56+/CD3- NK-cells    CD3+ T-cells  CD19+ B-cells    Placebo  Healthy volunteers were treated with BL-8040 or placeboSingle administration of BL-8040 triggered substantial mobilizationLong receptor occupancy results in prolonged effect (≥ 24 hours)   Time post BL8040 (hr) 
 

 BL-8040 Increases T-Cell Infiltration into Tumors (mice model)    Model: Orthotropic syngeneic tumors in pancreas of C57BL/6 male mice Treatment with BL-8040 for 10 consecutive days Treatment with BL-8040 induces accumulation of CD3+ T-cells in PDA tumors  IHC: aCD3 
 

 BL-8040 Increases T-Cell Infiltration into Tumors (cont.)  FACS analysis confirmed enrichment of immune cells within the tumor   * Tumor sections were enzymatically digested and single cell suspensions were analyzed by FACS** Values in the table represent absolute cell count  
 

 BL-8040 Affects the Tumor Microenvironment(CXCR4/SDF-1 Immuno-Suppressive Role in Cancer)  SDF-1 expression is an independent predictor of poor survival in cancer patientsCXCR4/SDF-1 axis is key pathway mediating the attraction of immuno-suppressive cells (MDSCs, Tregs, pDCs) to the tumor environment CXCR4 inhibition selectively reduces infiltration of Tregs into tumors and inhibits the migration of MDSCs to the tumor  Righi E. et al., Cancer Res 2011;Zou W et al., Nature Medicine, 2001;Obermajer et al., Cancer Res, 2011    Ovarian epithelial carcinoma cells express functional SDF-1     CXCR4 inhibition  High CXCR4 expression in cancer–isolated MDSCs   MDSCs migration is inhibited by CXCR4 blockade 
 

 Immunotherapy Collaboration with Genentech  Four phase 1b studies planned to investigate combination of BL-8040 with Genentech’s TecentriqTM (Atezolizumab - anti-PDL1 immune checkpoint inhibitor)Genentech to sponsor and conduct three phase 1b studies in multiple solid tumors BioLineRx to sponsor and conduct phase 1b study in (maintenance) AMLOpen-label, repeated administration studies in up to 60 patients eachStudy endpointsClinical response, safety and tolerabilityMultiple pharmacodynamic parametersStudies are expected to commence in H2 2017; top-lineresults expected in 2019 
 

 Immunotherapy Collaboration with Merck  Phase 2a study to examine combination of BL-8040 with Merck’s Keytruda® (anti-PD1 immune checkpoint inhibitor)Up to 30 patients with metastatic pancreatic adenocarcinomaOpen-label, single-arm trial with sites in the US, Israel and South KoreaStudy endpointsClinical response, safety and tolerabilityMultiple pharmacodynamic parameters, including ability to improve infiltration of T cells into tumor and their reactivityStudy commenced at end of Q3 2016Partial results expected H2 2017Top-line results expected H2 2018 
 

 BL-8040 in AML 
 

 *  BL-8040 Mechanism of Action in AML  Binds CXCR4 with high affinity (1-10 nM)Maintains extended inhibition of CXCR4 through long receptor occupancy (>24 hours)BL-8040 induces apoptosis of AML blasts by down-regulation of survival factorsBone-marrow clearance - eliminates minimal residual disease  BL-8040 directly induces apoptosis  BL-8040 sensitizes tumor cells to other drugs  BL-8040Induces terminal differentiation of tumor cells   BL-8040induces tumor cells mobilization 
 

 BL-8040 Mechanism of Action in AML  Binds CXCR4 with high affinity (1-10 nM)Maintains extended inhibition of CXCR4 through long receptor occupancy (>24 hours)BL-8040 induces apoptosis of AML blasts by down-regulation of survival factorsBone-marrow clearance - eliminates minimal residual disease        BL-8040 directly induces apoptosis  BL-8040 sensitizes tumor cells to other drugs                                    BL-8040  BL-8040  BL-8040Induces terminal differentiation of tumor cells             BL-8040  BL-8040 + SOC  BL-8040induces tumor cells mobilization 
 
 *  BL-8040 in AML – Background and Direction  Company conducted successful proof-of-concept phase 2a study in relapsed/refractory AML (45 patients)Showed robust bone marrow clearance, induction of apoptosis and terminal differentiation of AML cells Excellent safety and tolerability 
 

 BL-8040 in AML – Background and Direction  Company conducted successful proof-of-concept phase 2a study in relapsed/refractory AML (45 patients)Showed robust bone marrow clearance, induction of apoptosis and terminal differentiation of AML cells Excellent safety and tolerability 
 
 AML – Clinical Development Status  Results support accelerated development in AML space with potential for elimination of minimal residual disease (MRD)Consolidation AML phase 2b study ongoing194 patients, double-blind, placebo controlled at ~25 sites in GermanyEnrollment ongoing: potential interim results in 2018; top-line results by end of 2019Maintenance AML phase 1b study (under Genentech collaboration) in late planning stagesCombination with Atezolizumab as maintenance therapy for high-risk, elderly AML patientsUp to 60 patients, open label study at multiple leading sites in the USExpected to commence in H2 2017 
 

 BL-8040 in SC Mobilization   
 

     Stem Cell Mobilization for Autologous Transplantation  G-CSF is current standard for autologous stem cell mobilization4-6 daily injections of G-CSF, plus 1-4 apheresis sessions required50-70% of patients are poor mobilizersFor poor mobilizers, 1-4 daily injections of Mozobil on top of G-CSF are requiredFast route to registration in autologous SCMRegistrational study expected to commence in H2 2017 based on confirmatorymeeting with FDA held in April 2017:BL-8040 plus G-CSF will be compared to G-CSF plus placeboStudy expected to enroll ~200 patients in totalPrimary endpoint: proportion of patients who mobilize ≥6 million CD-34+ cells in up to 2 leukapheresis sessions in MM patientsPhase 2 allogeneic transplantation study ongoing as complementary indicationSuccessful partial results recently announcedSingle injection of BL-8040 mobilizes sufficient amounts of cells without need for G-CSFTopline results by end of 2017 
 

 BL-8040 is Powerful Mobilizer of CD34+ Cells  Substantial HSC mobilization from BM to PB was recorded Consistent pattern of mobilization across all subjects treated with BL-8040   Time post BL-8040 (hr)  BL-8040: 
 

 Single BL-8040 Administration Results in Robust Collection of Stem Cells Using Single Apheresis  Subject #  Whole blood processed (L)  % CD34+ cells  CD34+/KG (Donor weight)  CD34+/KG (70kg recipient weight)  5001  9.8  0.75   4,091,848    5,091,429   5002  16.0   1.01   11,964,615    11,998,800   5003  16.6   0.85   13,667,866    14,917,500   5004  16.2   0.76   10,154,834    11,794,114   5005  16.6   0.78   11,366,255    15,230,781   5006  16.5   0.87   13,068,548    14,711,451   5007  17.5   0.64   11,076,197    9,652,114   5008  16.7   0.61   9,623,736    9,994,937   Median  16.5 ± 2.3 L   0.77 ± 0.13 %   11.2 x 106 (± 2.8 x 106)   11.9 x 106 (±3.5 x 106)  Leukapheresis started 4 hrs post BL-8040 injection using the Spectra Optia® Apheresis SystemThe median amount of collected stem cells was higher than 11 x 106 per kg     CD34+/µL ; WBC x 103/ µL      Time post BL-8040     CD34+ PB levels 24 hr post BL-8040 are still high even after leukapheresis 
 

 CXCR4 Competitor Landscape  Compound(Company)  Dev. Stage  Molecule Type  Indications (under development)  AML  SCM  IO  BL-8040 (BioLineRx)  Phase 2  Peptide (sc)  Auto/Allo SCM; AML (r/r, consolidation, maintenance);Solid tumors (gastric, pancreatic, NSCLC)  Ph 2  Ph 3 ready  Ph 1/2 (+Pembro/+Atezo)  Mozobil (Genzyme/Sanofi)  Launched  Small molecule (IV)  Auto SCM;AML; Solid tumors (pancreatic, ovarian and colorectal cancers)  Ph 1/2  Launched  -  LY-2510924(Eli Lilly)  Phase 2  Peptide (IV)  r/r AML; solid tumors  Ph 1  -  Ph 1 (+Durvalumab)  Ulocuplumab(BMS)  Phase 2  Ab(IV)  AML  Ph 1/2  -   Terminated  X4P-001(X4 Pharmaceuticals)  Phase 2/3   Small molecule (oral)  WHIM syndrome; RCC, melanoma; ovarian cancer  -  -  Ph 1/2 (+Pembro/+Nivo) 
 

   BL-8040  Mozobil  Ulocuplumab  Affinity for CXCR4  1-10 nM  84 nM   5nM  CXCR4 Binding site  Extracellular domains in the CXCR4 receptor   Trans-membrane regions in the CXCR4 receptor   Extracellular domains in the CXCR4 receptor   Molecule Type  Peptide   Small molecule   Ab  Plasma half-life  1-3 hr  ~3-5 hr  More than 24hr  Receptor occupancy   More than 24 hr  ~2 hr  Not published  Cancer Cell Death  Remarkable apoptosis in samples from clinical study patients (Phase 2 study rrAML)  Has no effect on cancer cell apoptosis(Reum H et al., 2015)  Apoptosis of AML cells. Modest effect in patients.(ASH 2013)   Mobilization (fold increase leukocytes/ blast)  4/8 (Phase 2 in rrAML)  1.8/2.8(Uy G.L. et al.,  Blood 2017; Phase 1/2 in rrAML)   2/5  (Becker P.S. et al; Blood 2014; Phase1 in rrAML)  T-Cell Infiltration into Tumors   Infiltration was demonstrated in preclinical murine models   Infiltration was demonstrated in preclinical murine models  Not published  Other remarks re BL-8040 (Abraham M et al., 2017):BL-8040 induces apoptosis of AML blasts by down-regulating ERK BCL-2, MCL-1 and cyclin-D1 BL-8040 synergizes with FLT3 and BCL-2 inhibitors to induce AML cell death               Superior  Neutral  Inferior  BL-8040 is Best-in-Class vs. Competitors 
 

 BL-8040 Summary  Most advanced antagonist of CXCR4, an exciting and validated targetRobust platform for multiple oncology indicationsImmunotherapyAMLStem-cell mobilization/transplantationSignificant efficacy demonstrated in numerous clinical studiesPartnerships with Genentech and Merck in immuno-oncologyRegistrational study in autologous SCM expected to start in H2 2017 
 

 AGI-134  Alpha-Gal immunotherapy, activating anti-tumor response to patient’s own neoantigens 
 

 AGI-134 Highlights  Unique mechanism harnessing naturally occurring immune machineryPromotes systemic anti-tumor response against patient’s own tumor antigensApplicable for large array of tumorsTargets primary tumor, as well as existing and potential future metastasesReduces immuno-suppressive nature of tumor microenvironmentNear-clinical stage (following pre-IND meeting)Phase 1 in solid tumors expected to initiate in H1 2018; final preparations underwayProposed initial indications: melanoma, liver, head and neck, colorectal, breast cancer, lymphomaStudies to include substantial biomarker identification 
 

   AGI-134 Mechanism of ActionTransforming cold into hot tumors, targeting patient’s own neoantigens    Coating of tumor cells by AGI-134   Tumor destruction  Intra-tumoral injection of AGI-134  Binding of anti - a Gal antibodies  Initial cell death   Spillage of tumor-associated antigens  Alteration of tumormicroenvironment                                                              Increased uptake by antigen presenting cells  Stimulation & recruitment of T cells                      Antigen presenting cell  Tumor cell  AGI-134  NK cell  C3a / C5a  Neoantigens  T cell  C1q  anti - a Gal           
 

 AGI-134: Key Efficacy Findings  In vitro and in vivo studies have validated the underlying steps of the MOASingle dose of AGI-134 demonstrated systemic effect by protecting mice from secondary tumor development for over 90 days Combination of AGI-134 with immune checkpoint inhibitor (PD-1) gave increased efficacy over either agent alone     
 

 AGI-134: Unique MOA Among Intratumoral Agents    Oncolytic viruses  PAMPs  AGI-134  Injected tumor cells identified by naturally occurring pre-existing antibodies        Antibody-bound tumor cells destroyed by activated complement and ADCC        Tumor neoantigens release by spilling        Antibody-activated complement system creates pro-inflammatory milieu in the tumor microenvironment        Complement chemo-attractants recruit immune cells to the tumor        Activation of antigen presenting cells and increased (APCs) uptake of tumor antigens        APCs induce a follow-on systemic immune response by the stimulation and clonal expansion of T cells       
 

 AGI-134 Summary  Novel and demonstrated mechanism of action Technology potential Addresses wide range of poorly treated solid tumorsTransforms “cold” into “hot” tumorsTargets patient’s neoantigensStrong pre-clinical data, clear development pathway discussed with MHRA and FDANear-clinical stage, with first-in-man study expected to initiate H1 2018Phase 1/2 development plan designed to include comprehensive biomarker strategyDemonstrated synergy with immune checkpoint inhibitorsAcquisition of Agalimmune provides BioLineRx with several earlier-stage projects, as well additional capabilities to augment focus on immunology and oncology 
 

 Corporate   
 

 BioLineRx Management  Philip A. Serlin, CPA, MBA – Chief Executive OfficerServed as the Company’s CFO and COO from 2009 to 2016. Previously CFO and COO of Kayote Networks and CFO of Tescom Software Systems Testing. Background includes senior positions at Chiaro Networks and at Deloitte in Tel Aviv, and at the SEC in Washington, D.C.Mali Zeevi, CPA – Chief Financial OfficerServed as the Company’s Senior Director of Finance and Reporting 2009-2016. Previously Vice President Finance at Tescom Software Systems Testing and manager at PriceWaterhouseCoopers.David Malek, MBA – Chief Business OfficerJoined the Company in 2011 as Vice President of Business Development. Previously in various management positions at Sanofi-Aventis, including Director of Oncology - New Products and Business Development.Ella Sorani, PhD – VP DevelopmentJoined the Company in January 2017. Previous 16 years served in a number of management positions in the global R&D division at Teva Pharmaceutical Industries. In most recent position, led global development of one of Teva’s leading innovative late stage compounds. Abi Vainstein, MD – VP Clinical and Medical AffairsServed as the Company’s Senior Medical Director from 2014 to 2016. Previously Director and Clinical Program Leader for COPAXONE®, and several other senior medical positions at Teva Pharmaceutical Industries. 
 

 Strategic Collaboration with Novartis  Novartis selected BLRX as its partner for asset identification and early developmentExclusive first look at all Israeli-based projects scouted by BioLineRxCo-develop selected projects through clinical proof-of-concept (POC)Unique collaboration provides lasting shareholder value and key insights3 projects brought under collaboration so far, in areas of fibrosis and inflammationFinancial highlights:Upfront $10 million equity investment in BLRXUpon selection of clinical project (or when a project reaches IND), BioLineRx receives:$5 million option fee (non-dilutive)50% of remaining R&D expenses up to POC (in equity at a premium to market)Novartis receives right of first negotiation for full out-license upon clinical POC 
 

 Cash position$55 million as of April 30, 2017Existing financial resources fund operational requirements into 2019Capital structureTraded on NASDAQ and TASE (Symbol: BLRX)96 million shares outstanding; 104 million fully dilutedUS shareholders represent ~70% of investor base, including key life-sciences investorsOther~50 employees, approximately 2/3 with advanced degreesAnalyst coverage: JMP Securities, HC Wainwright, Maxim Group  Financial Summary 
 

 Principal Expected Development Milestones in 2017/2018  2018  2017  BL-8040 (Autologous SCM) phase 3 initiation     BL-8040 (Pancreatic Cancer) phase 2 partial results    BL-8040 (Allogeneic SCM) phase 2 top-line results    BL-8040 (AML Maintenance) phase 1b initiation    BL-8040 (Multiple Solid Tumors) phase 1b initiation    BL-8040 (Pancreatic Cancer) phase 2 top-line results    BL-8040 (AML Consolidation) phase 2b interim analysis    Does not include milestones expected from newly in-licensed programs  BL-8040 (AML Maintenance) phase 1b partial results    BL-8040 (Multiple Solid Tumors) phase 1b partial results    AGI-134 (Multiple Solid Tumors) phase 1/2 initiation    BL-8040 (Allogeneic SCM) phase 2 partial results    √ 
 

 Takeaways……  Focus on oncology and immunology (mainly immuno-oncology)9 clinical studies ongoing or planned for next 12-18 monthsRead-out from 3-4 phase 2 studies over next 12-18 monthsInitiation of phase 3 registrational study expected in H2 2017Significant collaborations with 3 of the leading global pharma companiesAnticipated new clinical/advanced pre-clinical compounds to enter pipelineContinued execution of strategic transactions as opportunities arise 
 

   Thank  You