TEL AVIV, Israel, December 5, 2016 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage
biopharmaceutical company dedicated to identifying, in-licensing
and developing promising therapeutic candidates, presents positive
Phase 2a correlative data, as well as detailed mechanism-of-action
data, for BL-8040, the Company's leading oncology platform at the
ongoing 58th American Society of Hematology (ASH) Annual Meeting
and Exhibition in San Diego,
California.
As previously announced, in an oral presentation at 10:30am PST today, entitled, "The High Affinity
CXCR4 Inhibitor, BL-8040, Induces Apoptosis of AML Blasts and their
Terminal Differentiation by Blocking AKT/ERK Survival Signals and
Downregulating BCL-2, MCL-1 and Cyclin-D1 through Regulation of
miR-15a/16-1 Expression," BioLineRx reports detailed data on the
mechanism-of-action by which BL-8040 directly induces apoptosis of
AML cells. The data, presented by Prof. Amnon Peled, are from in vitro studies
using human AML cell lines and human primary AML samples, as well
as in vivo studies using human primary AML cells engrafted
in NOD scid gamma (NSG) mice.
In addition, yesterday, in a poster titled, "The Selective Anti
Leukemic Effect of BL-8040, a Peptidic CXCR4 Antagonist, is
Mediated by Induction of Leukemic Blast Mobilization,
Differentiation and Apoptosis: Results of Correlative Studies from
a Ph2a Trial in Acute Myeloid Leukemia," BioLineRx reported the
final correlative results from its Phase 2a trial in acute myeloid
leukemia (AML). The trial consisted of 45 AML patients receiving
BL-8040 monotherapy on days 1-2, followed by the same dose of
BL-8040 plus chemotherapy (Cytarabine) on days 3-7. All patients
had poor-risk disease and had been heavily pretreated, with 19%
having relapsed after a short first remission (≤12 months), 17%
having 2 or more relapses, while 45% were refractory to 1-2
induction treatments. The composite complete remission rate,
including both complete remission (CR) and complete remission with
incomplete blood count recovery (CRi), was 38% in subjects
receiving BL-8040 dose ≥1.0 mg/kg (n=39). These response rates are
superior to the historical response rate of approximately 20%
reported for high-risk AML patients treated with Cytarabine
alone.
Philip Serlin, CEO of BioLineRx,
commented, "We are excited to take part in the world's premier
event in malignant and non-malignant hematology, with over 20,000
hematology professionals from every subspecialty in attendance. At
this event, we are pleased to present additional positive results
about BL-8040. This includes clinical data that supports the
rational for incorporation of BL-8040 in front-line AML treatment
settings, such as AML consolidation and maintenance. In this
regard, we are currently running a large Phase 2b study in
consolidation AML, and we expect to initiate a Phase 1b study in
maintenance AML under our collaboration with Genentech in mid-2017.
We are also pleased to see pre-clinical data that support the
mechanism of action of BL-8040 and show synergistic effects of
BL-8040 with drugs that are also being investigated as AML
treatments. We continue to anticipate that BL-8040, in combination
with a growing repertoire of drugs, will be able to offer hope in
this difficult to treat condition."
About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid
leukemia, solid tumors, and certain hematological indications. It
functions as a high-affinity antagonist for CXCR4, a chemokine
receptor that is directly involved in tumor progression,
angiogenesis, metastasis and cell survival. CXCR4 is over-expressed
in more than 70% of human cancers and its expression often
correlates with disease severity. In a number of clinical and
pre-clinical studies, BL-8040 has shown robust mobilization of
cancer cells from the bone marrow, thereby sensitizing these cells
to chemo- and bio-based anti-cancer therapy, as well as a direct
anti-cancer effect by inducing apoptosis. In addition, BL-8040 has
also demonstrated robust stem-cell mobilization, including the
mobilization of colony-forming cells, and T, B and NK cells.
Furthermore, scientific findings in the field of immuno-oncology
suggest that CXCR4 antagonists may be effective in inducing the
infiltration of anti-tumor T cells into the tumor. Therefore, when
combined with immune checkpoint inhibitors, BL-8040 has the
potential to enable activated T cells to better reach tumor cells.
BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was
previously developed under the name BKT-140.
About BioLineRx
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 and is in the midst of a Phase
2b study as an AML consolidation treatment and 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), on the basis of which the Company has
initiated a Phase 2a study in pancreatic cancer using the
combination of BL-8040 and Merck's KEYTRUDA®; and 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.
For additional information on BioLineRx, please visit the
Company's website at http://www.biolinerx.com, where you can review
the Company's SEC filings, press releases, announcements and
events. BioLineRx industry updates are also regularly updated on
Facebook, Twitter, and LinkedIn.
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
SOURCE BioLineRx Ltd.