TEL AVIV, Israel, September 26, 2017 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage
biopharmaceutical company focused on oncology and immunology,
announced today the initiation of a Phase 1b/2 trial for BL-8040 in
combination with atezolizumab (TECENTRIQ®), an anti-PDL1
cancer immunotherapy from Genentech, a member of the Roche Group.
The trial, known as the BATTLE study (NCT03154827), will focus on
the maintenance treatment of patients with intermediate and
high-risk acute myeloid leukemia (AML) who have achieved a complete
response (CR) following induction and consolidation therapy.
Up to 60 patients are planned to be enrolled in this
multicenter, single arm, open-label study, to evaluate the
relapse-free survival, minimal residual disease status, safety and
tolerability of the combination of BL-8040 and atezolizumab for
maintenance treatment in AML patients. The study's primary endpoint
is to assess whether the combination of BL-8040 and atezolizumab
prolongs relapse free survival. In addition, the effect of the
combination therapy on minimal residual disease, multiple
immunological parameters and potential biomarkers will be
evaluated. The trial is planned to take place at approximately 22
sites in the U.S., Europe and
Israel.
The BATTLE study is a part of BioLineRx's cancer immunotherapy
collaboration with Genentech to conduct several Phase 1b/2 studies
investigating the combination of BL-8040 with atezolizumab in
multiple cancer indications, announced in September 2016.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "We are excited to commence yet
another clinical study under this significant immuno-oncology
collaboration, following the recent initiation of a study to
evaluate the combination of the same two drugs for the treatment of
pancreatic cancer. The BATTLE study is the first study under our
collaboration in hematologic malignancies, and we are hopeful that
combining atezolizumab with BL-8040 will demonstrate the potential
to establish a new treatment for AML patients that would extend the
duration of remission following induction treatment, in particular
for patients for whom stem-cell transplantation is inappropriate.
We look forward to the initiation of additional combination studies
under this collaboration, all planned by the end of this year."
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.
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 AML, 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 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/2 studies
for multiple solid tumor indications and AML.
TECENTRIQ® (atezolizumab) is a registered trademark
of Genentech, a member of the Roche Group.
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 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.
Contact:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.