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 November 2016

 

_______________________

 

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:        

 

 

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:          

 

 

On November 21, 2016, the registrant will issue the press release which 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: November 21, 2016

 

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BioLineRx In-licenses Novel Anti-Inflammatory Treatment

for Dry Eye Syndrome Under Strategic Collaboration with

Major Global Pharmaceutical Company

 

 

Tel Aviv, Israel – November 21, 2016 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has signed an exclusive, worldwide agreement with Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., for the in-licensing of a novel anti-inflammatory treatment for Dry Eye Syndrome (DES). This project, to be named BL-1230, is the third project in-licensed under the framework of the Company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.

DES is one of the most prevalent ophthalmic medical conditions, particularly in the elderly, affecting up to 30% of the global population aged 50 years and above, with around 40 million people affected in the US alone. The condition leads to discomfort, inflammation and pain. Currently, treatment options are very limited, and include constant rehydration with artificial tears and local immunosuppressants.

BL-1230 is a potent and selective cannabinoid receptor type 2 (CB2R) agonist developed by Professor Raphael Mechoulam from the Department of Medicinal Chemistry and Natural Products at the Faculty of Medicine of the Hebrew University. The involvement of CB2R in immune modulation is well established, and pre-clinical studies in three ocular inflammatory models have demonstrated that BL-1230 eye drops have significant anti-inflammatory activity, which attenuates the pathology and improves histological outcomes. In addition to DES, BioLineRx intends to explore the potential use of this compound in systemic inflammatory conditions.

“BL-1230 is an additional project in our growing immunology portfolio and already the third project in-licensed under the Company’s exciting strategic collaboration with Novartis for the screening and development of novel drug candidates,” commented Philip Serlin, Chief Executive Officer, BioLineRx. “Inflammation is recognized as both a cause and consequence of DES and is a primary target in assessment and clinical treatment. BL-1230 not only targets inflammation via an immunomodulatory pathway that differs from current treatment options, but also may induce analgesic effects. We therefore hope that this drug will have a beneficial therapeutic effect as compared to available treatments.”

About Dry Eye Syndrome

Dry eye syndrome (DES) is a disease resulting in dryness, tear film instability, irritation, redness, itchy feeling, eye fatigue and even blurred vision, with potential damage to the ocular surface. DES can result from various reasons, including tear gland dysfunction, allergies, Sjogren’s syndrome, or as a side effect of certain medications or surgery. It is a common eye disease, affecting up to 30% of the global population to some degree, and can affect up to 70% of elderly people. Artificial tears are the standard first line treatment. The only FDA approved anti-inflammatory drugs for this condition are Restasis (topical cyclosporine 0.05%, Allergan) and Xiidra (ICAM1i, Shire).

BioLineRx is a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx’s leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment, and has recently initiated a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA^®; and has recently signed a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.

Various statements in this release concerning BioLineRx’s future expectations constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as ”may,” ”expects,” “anticipates,” “believes,” 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. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the ”Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com

or

Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com

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