TEL AVIV, Israel, October 18, 2017 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ: BLRX) (TASE:
BLRX), a clinical-stage biopharmaceutical company focused on
oncology and immunology, announced today that Genentech, a member
of the Roche Group, has commenced a Phase 1b/2 study for the
treatment of gastric cancer with BL-8040 in combination with
atezolizumab (TECENTRIQ®), Genentech's anti-PDL1 cancer
immunotherapy agent.
Up to 40 patients are planned to be enrolled in this
multicenter, randomized, controlled, open-label study to evaluate
the clinical response, safety and tolerability, as well as multiple
pharmacodynamic parameters, of BL-8040 in combination with
atezolizumab. Initially, patients will receive BL-8040 injections
as priming monotherapy, after which they will receive both BL-8040
and atezolizumab, and continue with multiple treatment cycles for
up to two years or, until disease progression, clinical
deterioration or unacceptable toxicity.
The clinical study collaboration between BioLineRx and Genentech
is part of MORPHEUS, Roche's novel cancer immunotherapy development
platform. MORPHEUS is a phase 1b/2 adaptive platform to develop
combinations of cancer immunotherapies more rapidly and
efficiently.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "This is the third trial to commence
under our collaboration with Genentech for the combination of our
CXCR4 inhibitor lead oncology platform and their anti-PDL1
inhibitor, following initiation of a pancreatic cancer study in
July and initiation of an AML study in September. We are therefore
hopeful that combining atezolizumab with BL-8040 can lead to a
significant advancement in the treatment of gastric cancer, and of
other solid tumors that are difficult to treat. BL-8040 has shown
to induce robust mobilization of immune cells, improve the
infiltration of T cells into solid tumors, and affect the
immunosuppressive tumor micro-environment. We look forward to the
results of this trial and the initiation of an additional
combination study under this collaboration, planned for later this
year."
This study is being carried out as part of BioLineRx's cancer
immunotherapy collaboration with Genentech, which includes several
Phase 1b/2 studies investigating BL-8040 in combination with
atezolizumab in multiple cancer indications, announced in
September 2016.
BL-8040, BioLineRx's lead oncology platform, is a CXCR4
antagonist that has been shown in clinical trials to be a robust
mobilizer of immune cells and to be effective in inducing direct
tumor cell death. Additional findings suggest that BL-8040 may be
effective in inducing the migration of anti-tumor T cells into the
tumor micro-environment, as well as improving the infiltration of T
cells into solid tumors. Atezolizumab is a humanized monoclonal
antibody designed to bind to PD-L1 in tumor cells and tumor
infiltrating immune cells and blocks interactions with the PD-1 and
B7.1 receptors. Through this interaction, atezolizumab may enable
the activation of T cells, whose migration into the tumor may be
enhanced by BL-8040.
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 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.
Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com
Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.