Foreign Filer Report • Dec 5, 2017
Foreign Filer Report
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WASHINGTON, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2017
_______________________
(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 ☒ On December 5, 2017, the registrant will be hosting an investor breakfast meeting in New York City beginning at 9:00 am EST. At the meeting, the registrant will present updates about its main therapeutic candidates and corporate objectives. The presentation to be made to investors is filed as Exhibit 1 to this Report on Form 6-K
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the Company 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: December 5, 2017

This presentation contains "forward-looking statements." These statements include words like "may," "expects," "believes," "plans," "scheduled," 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.

Immunology franchise with Novartis
Genentech A Member of the Roche Group

25 NOVARTIS Attractive investment case
Strong balance sheet
\$55 million (end Q3 2017)
Significant upcoming milestones:
| CANCER Stem-cell mobilization BL-8040 Consolidation AML Maintenance AML Gastric cancer Non-small cell lung cancer Pancreatic cancer 3 MSD Pancreatic cancer AGI-134 Solid tumors IMMUNOLOGY Type 1 diabetes BL-9020 Liver failure diseases BL-1220 BL-1230 Dry eye syndrome OTHER Skin lesions BL-5010 Perrigo |
PROJECT | INDICATION | PRE-CLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | REGULATORY APPROVAL |
|---|---|---|---|---|---|---|---|
| Genentech | |||||||
| U novartis | |||||||
| BIOLINERX |





Expected to start Q4 2017 - Phase 3 randomized, placebo-controlled, safety and efficacy study (n=177): NCT03246529

Part 1: Lead in period - dose confirmation in up to 30 Multiple Myeloma patients
Part 2: Randomized placebo controlled study in combination with G-CSF in 177 Multiple Myeloma patients
G-CSF, granulocyte-colony stimulating factor Clinicaltrials.gov. NCT0346529

| Objectives | To demonstrate that the combination of BL-8040 + G-CSF is superior to G-CSF alone in |
|---|---|
| Primary | The ability of mobilize > 6M CD34+ cells in up to 2 apheresis |
| Secondary | The ability to mobilize > 2M CD34+ cells in 1 apheresis |
| Safety and Tolerability | ls safe and tolerable |
| Other Objectives | The combination will also be tested with regard to: |
|---|---|
| Time to engraftment of neutrophils and platelets | |
| Durability of engraftment |


Mobilizing and promoting infiltration of immune cells and reducing immunosuppression in the tumor microenvironment


Phase 2a open-label study in combination with Pembrolizumab (n=30): NCT02826484
A Phase 2a, multi-center, open-label study and efficacy of BL-8040 in combination with Pembrolizumal (Keytruda) in patients with advanced pancreatic cancer



A phase 2a, multicenter, open-label study to assess the safety and efficacy of BL-8040 in combination with Pembrolizumab (Keytruda) in patients with advanced pancreatic cancer
| Objectives | To demonstrate that the combination of BL-8040 and Pembrolizumab |
|---|---|
| Primary | Induces responses assessed as overall response (CR+PR) |
| Prolongs the progression free survival (PFS) | |
| Secondary | Prolongs the overall survival (OS) |
| Safety and Tolerability | Is safe and tolerable |
| Other Objectives | Assessment of |
|---|---|
| Disease control assessment (CR+PR+SD) | |
| Biomarkers for monotherapy and combination treatment | |
| Biopsy assessment for infiltration | |
| Immunophenotyping |

| Site | City/Country | Pl | Patients enrolled |
|---|---|---|---|
| Beth Israel Deaconess MC | Boston/US | study PI- | б |
| Rambam MC | Haifa/Israel | aum | 5 |
| Tel Aviv Sourasky MC | Tel Aviv/ Israel | it Geva | 4 |
| Sheba MC | Ramat Gan/ Israe | Talia Golan | 4 |
| Rabin MC | Petach Tik | Solomon Shtemer | 4 |
| Dana Farber Cancer Institute | TO MAPLE Bos |
Brian Wolpin | 4 |
| Washington University of St Louis | Katrina Pedersen | 2 | |
| Honor Health Research Institute | Izona/US | Erkut Borazanci | 3 |
| NEGROFINALENT Samsung MC |
Seoul/ South Korea | Joon Oh Park | 2 |
| Mayo Clinics | Arizona/US | Mitesh Borad/ Ramesh Ramanathan | 2 |
| Ochsner MC | New Orleans/LA | Robert Ramirez | 1 |
| Massachusetts Gereral Hospital | Boston/US | David Ryan | 0 |
| Baylor Charles A. Sammons Cancer Center | Dallas/US | Carlos Becerra |


Phase 1/2a dose escalation/expansion study (n=42): NCT01838395

Dose escalation (0.5 to 2.0 mg/kg) with expansion cohort at 1.5mg/kg
CR, complete response; CRi, complete response with incomplete hematological recovery; AML, Acute Myeloid Leukemia

| Population | Relapsed or refractory AML patients including patients after allogeneic transplantation |
|||||
|---|---|---|---|---|---|---|
| Primary Endpoint | Safety and Tolerability | BL-8040 was found to be safe and well tolerated in combination with high dose cytarabine |
||||
| Secondary endpoint | Composite Response rate of 38% in subjects receiving BL-8040 dose ≥1.0 mg/kg (n=39), compared to 16.3 % with cytarabine according to historical data* |
|||||
| Exploratory endpoint | BL-8040 was found to be pro-apoptotic as a single agent | |||||
| Bl-8040 was found to mobilize blasts to the peripheral blood |
*VALOR Study, Ravandi et al.

Circles displayed identify censoring pattern
Phase 2b double-blind, placebo controlled study (n=194): NC T02502968
Treatment: Two or three cycles (age-based) of consolidation with high-dose Ara-C together in combination with either BL-8040 or placebo


| Objectives | To demonstrate that the combination of BL-8040 High Dose Cytarabine (HiDAC) |
|---|---|
| Primary | Prolongs the Relapse free survival |
| Secondary | Reduces the minimal residual disease (MRD) |
| Prolongs the Overall survival | |
| Safety and Tolerability | Is safe and tolerable. |

Phase 1b/2 single arm, open-label study (n=60): NCT03154827
A Phase 1b/2, multi-center, single arm, open-label study, to evaluate the safety and efficacy of BL-8040 in combination with Atezolizumab for maintenance treatment in AML patients of 60 years or older that are not fit for transplant

| Objectives | To demonstrate that the combination of BL-8040 and Atezolizumab |
|---|---|
| Primary | Prolongs the relapse free survival (RFS) time as compared to historical data. |
| Secondary | Reduces the minimal residual disease (MRD) |
| Prolongs the Overall Survival (OS) time as compared to historical data. | |
| Prolongs the time to first relapse as compared to historical data. | |
| Safety and Tolerability | Is safe and tolerable. |

AGI-134: a novel and unique immuno-oncology agent tackling the challenge of tumor neoantigen heterogeneity


Xenotransplantation experiments in the 1980s-90s found that, when introduced to humans, the alpha-Gal-positive tissue was bound by preexisting human anti-Gal antibodies, which were the main cause of the rejection, e.g. of porcine heart valves




A fully synthetic a-Gal glycolipid molecule for intratumoral injection into solid tumors, to induce an immune response against a patient's own neoantigens





| And Sunny General A 1979 |
Post polices of colliers concel upportunes |
a populars for porpo storonise delivious activitions and |
Oleophing one and | ||
|---|---|---|---|---|---|
| Evokes personalized anti-tumor immunity | V | V | |||
| Targets a multitude of patient-specific neoantigens | V | ||||
| Does not require complex ex vivo processing or computer modelling |
V | ||||
| Harnesses pre-existing antibodies | V | ||||
| Directly labels the treated tumor for destruction | V | ||||
| Activates the complement cascade, creating a proinflammatory TME |
V |
*NewLink Genetics were developing a whole-cell cancer vaccine using alpha-Gal to boost immunogenicity. As whole-cell cancer vaccines do not target patient-specific neoantigens and do not atter the TME, they failed in Ph 3


A comprehensive immune monitoring strategy that aims to:






Our plan is to become a significant player in the biotech industry
We intend to achieve the following:

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