TEL AVIV, Israel, May 22, 2017 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ: BLRX, TASE: BLRX), a clinical-stage
biopharmaceutical company focused on oncology and immunology,
announced today the filing of regulatory submissions required to
commence a Phase 1b trial for BL-8040 in combination with
atezolizumab (Tecentriq®), Genentech, a member of the
Roche Group's anti-PDL1 cancer immunotherapy, for the maintenance
treatment of patients with acute myeloid leukemia (AML) who have
achieved complete response following induction therapy. The trial,
named BATTLE, is expected to commence in the second half of 2017,
following receipt of regulatory approval.
This clinical study is part of BioLineRx's cancer immunotherapy
collaboration with Genentech to conduct several Phase 1b studies
investigating BL-8040 in combination with atezolizumab in multiple
cancer indications, announced in September
2016. The Phase 1b study will evaluate the clinical
response, safety and tolerability of the combination of these
therapies, as well as multiple pharmacodynamic parameters.
BL-8040, BioLineRx's lead oncology platform, is a CXCR4
antagonist that has been shown, in a successful Phase 2a study in
relapsed and refractory AML patients, to be a robust mobilizer of
immune and tumor cells and to be effective in inducing direct tumor
cell death. These two effects, when combined with
atezolizumab-induced blockade of the interaction between PD-L1 with
PD-1 and B7.1, are hypothesized to have a beneficial effect on the
minimal residual disease (MRD) status of AML patients.
Specifically, this combined approach could potentially reduce an
AML patient's MRD status from positive to negative, and possibly
have a favorable effect on disease outcome. This study's regimen
aims at further prolonging the period of remission, exploring a
novel maintenance approach to these patients.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "Our collaboration with Genentech in
multiple cancer indications is on target and advancing as planned.
Our robust partnership with a world leader in cancer immunotherapy
is very exciting, and we are looking forward to initiating this
combination study, which will hopefully demonstrate the potential
to expand the benefit of immunotherapy to cancer patient
populations that currently do not benefit from cancer immunotherapy
treatments."
About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid
leukemia, solid tumors, and stem cell mobilization. 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 cell
death (apoptosis). In addition, BL-8040 has also demonstrated
robust stem-cell mobilization, including the mobilization of
colony-forming cells, T, B and NK cells. BL-8040 was licensed by
BioLineRx from Biokine Therapeutics and was previously developed
under the name BKT-140.
About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is a cancer of the blood and bone
marrow and is the most common type of acute leukemia in adults.
According to the American Cancer Society, approximately 20,000
new cases of AML were diagnosed in the United States in
2016, and the median age of AML patients was 67 years old. The
first treatment line for patients with AML includes a combination
of chemotherapy drugs and is called induction treatment. The median
survival for AML patients receiving induction chemotherapy is less
than two years, with shorter survival for patients over the age of
60 or for those with certain gene or chromosome aberrations. Due to
relapsed or refractory disease (where the disease is not responsive
to standard treatments), the overall five-year survival rate for
AML is between 10 and 40 percent.
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused
on oncology and immunology. The Company in-licenses novel
compounds, 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 acute myeloid leukemia (AML) and
is in the midst of a Phase 2b study as an AML consolidation
treatment and is expected to initiate a Phase 3 study in stem cell
mobilization for autologous transplantation; and AGI-134, an
immunotherapy treatment in development for multiple solid tumors,
which is expected to initiate a first-in-man study in the first
half of 2018. In addition, BioLineRx has a strategic collaboration
with Novartis Pharma AG 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 Inc., 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.
Tecentriq® is a registered trademark of Genentech, a
member of the Roche Group.
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 23, 2017. 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.