BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage
biopharmaceutical company dedicated to identifying, in-licensing and
developing promising therapeutic candidates, announced today that
research underlying BL-9020, for the treatment of Type 1 diabetes, won
the Hebrew University's prestigious Kaye Innovation Award.
The award was granted to Hebrew University immunologist Professor Ofer
Mandelboim, who studied the function of a protein receptor called NKp46
in the development of Type 1 diabetes. Prof. Mandelboim showed that
NKp46 present on Natural Killer cells has a critical role in the
development of the disease in mice, and that inhibition of the receptor
almost entirely prevented the development of diabetes. This
groundbreaking research is the basis for BioLineRx’s BL-9020, a novel
monoclonal antibody which targets the Natural Killer (NK) receptor NKp46
for the prevention and treatment of Type 1 diabetes.
In January 2014, BioLineRx entered into a collaboration agreement with
JHL Biotech for the further development and commercialization of BL-9020
in China and additional Southeast Asia countries. Under the terms of the
agreement, BioLineRx retains the development and commercialization
rights in the rest of the world.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "Type 1 diabetes is a
highly prevalent autoimmune disease affecting millions around the world.
Currently there is no cure for the disease, and patients with diabetes
need to administer insulin on a daily basis throughout their lifetime.
Oftentimes, when the disease is diagnosed, patients experience a
'honeymoon period' which may last up to a year, during which there are
still some insulin producing cells in the pancreas. Inhibiting the
innate immune system, which has shown involvement in the destruction of
the pancreas, is a novel approach for such treatment. Based on promising
pre-clinical results, we have high hopes that BL-9020 may slow down or
halt progression of the disease at this stage, which could be a
significant step towards curing diabetes.”
BL-9020 is a novel monoclonal antibody treatment designed to prevent
immune-mediated destruction of insulin-producing beta cells in the
pancreas. It was developed to treat Type 1 diabetes in early stage
patients, during what is known as the "honeymoon period," where the
pancreatic beta cells have not been completely destroyed and continue to
secrete insulin. BL-9020 targets NKp46, a unique target that is involved
in the innate response against the pancreas. Pre-clinical studies in
mouse models of Type 1 diabetes suggest that BL-9020 can inhibit beta
cell death, thus preventing full maturation of the disease. This effect
could significantly delay, and potentially prevent, the need for chronic
insulin use by Type 1 diabetes patients, as well as provide a potential
benefit in minimizing diabetes-related complications.
About the Kaye Awards
The Kaye Awards have been given annually since 1994. Isaac Kaye from the
United Kingdom, a prominent industrialist in the pharmaceutical
industry, established the awards to encourage faculty, staff and
students of the Hebrew University to develop innovative methods and
inventions with good commercial potential which will benefit the
university and society.
About BL-9020
BL-9020 is a first-in-class, monoclonal antibody that targets the
Natural Killer (NK) receptor NKp46, which has been linked to Type 1
diabetes. Studies have shown that Natural Killer cells belonging to the
innate immune system have a key role in the damage to pancreatic cells
and, as a consequence, in the development of Type 1 diabetes. Professor
Ofer Mandelboim from the Hebrew University of Jerusalem and Professor
Angel Porgador from Ben-Gurion University, the inventors of BL-9020,
together with Professor Yaakov Naparstek and Dr. Chamutal Gur from
Hadassah Medical Center in Jerusalem, found that the NKp46 receptor
specifically recognizes pancreatic beta cells, leading to their
destruction. These findings demonstrate the importance of the NKp46
receptor in diabetes development and emphasize the therapeutic potential
of an anti-NKp46 monoclonal antibody as a new treatment modality for
Type 1 diabetes. The inhibition of the NK cell receptor, which
specifically targets the pancreas, is a novel mechanism with potential
to modify the course of the disease. BL-9020 is being developed by
BioLineRx under a worldwide exclusive license agreement with Yissum
Research Development Company of the Hebrew University of Jerusalem, B.G.
Negev Technologies and Applications, and Hadasit Medical Research
Services and Development.
About Type 1 Diabetes
Type 1 diabetes, which usually appears in children and adolescents,
results from auto-immune destruction of the pancreatic beta cells
producing insulin. This leads to a pathologically high level of sugar in
the blood and urine. This hyperglycemia leads to high morbidity and
mortality rates. Treatment of Type 1 diabetes is currently limited to
lifetime administration of insulin by injection. The disease affects
over 30 million people worldwide, and in 2012, the Type 1 diabetes
market was estimated at over $3.5 billion.
About BioLineRx
BioLineRx is a publicly-traded, 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 current portfolio consists of a variety of clinical and
pre-clinical projects, including: BL-1040 for prevention of pathological
cardiac remodeling following a myocardial infarction, which has been
out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a
pivotal CE-Mark registration trial scheduled for completion in mid-2015;
BL-8040, a cancer therapy platform, which is in the midst of a Phase 2
study for acute myeloid leukemia (AML), and has successfully completed a
Phase 1 study in stem cell mobilization; and BL-7010 for celiac disease,
which has successfully completed a Phase 1/2 study.
In December 2014, BioLineRx entered into a strategic collaboration
with Novartis for the co-development of selected Israeli-sourced novel
drug candidates. The companies intend to co-develop a number of
pre-clinical and early clinical therapeutic projects through clinical
proof-of-concept for potential future licensing by Novartis.
For more information on BioLineRx, please visit www.biolinerx.com
or download the investor relations mobile device app, which allows users
access to the Company’s SEC documents, press releases, and events.
BioLineRx’s IR app is available on the iTunes App Store as well as
the Google Play Store.
Various statements in this release concerning BioLineRx’s future
expectations, including specifically those related to the development
and commercialization of BL-9020, 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 23, 2015. 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.
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