TEL AVIV, Israel, July 10, 2017 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ/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 BL-8040 in combination with
atezolizumab (TECENTRIQ®), Genentech's anti-PDL1 cancer
immunotherapy agent, evaluating the combination in metastatic
pancreatic ductal adenocarcinoma.
Up to 40 patients are planned to be enrolled in this Phase 1b/2,
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 for five consecutive days, after which, from
day 8, 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, a member of the Roche Group, is part of MORPHEUS,
Roche's Novel Cancer Immunotherapy Development Platform. MORPHEUS
is a phase 1b/2 adaptive platform to assess the efficacy and safety
of combination cancer immunotherapies.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "We are very pleased with the launch
of the first clinical study under our cancer immunotherapy
collaboration with Genentech. Pancreatic cancer is a very difficult
cancer to treat, and both conventional chemotherapy and
immunotherapy have failed to demonstrate a significant benefit for
these patients. BL-8040 has been shown to have robust mobilization
of immune cells, improve the infiltration of T cells into solid
tumors, and affect the immunosuppressive tumor micro-environment.
We are therefore hopeful that combining atezolizumab with BL-8040
can lead to a significant advancement in the treatment of
pancreatic cancer, and of other solid tumors that are difficult to
treat. We look forward to the initiation of additional combination
studies under this collaboration, all planned for the second half
of this year."
BioLineRx is carrying out a larger cancer immunotherapy
collaboration with Genentech to conduct 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 acute myeloid leukemia (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 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
TECENTRIQ® in several Phase 1b/2 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® (atezolizumab) 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.