TEL AVIV, Israel, September 7, 2016 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ/TASE: BLRX) today announced that it has
entered into a collaboration with Genentech, a member of the Roche
Group, to support several Phase 1b studies investigating
BioLineRx's BL-8040 in combination with Atezolizumab, Genentech's
anti-PDL1 cancer immunotherapy, in multiple cancer indications. The
Phase 1b studies will evaluate the clinical response, safety and
tolerability of the combination of these therapies, as well as
multiple pharmacodynamic parameters, in hematologic malignancies
and solid tumors.
Under the agreement, Genentech will sponsor and conduct several
Phase 1b trials in multiple solid cancer indications. In addition,
BioLineRx will sponsor and conduct a Phase 1b study in acute
myeloid leukemia (AML) patients. The studies are planned as
open-label, multicenter, single-arm trials designed to evaluate the
safety and efficacy of the combination of BL-8040 and Atezolizumab.
Upon completion of the studies, both parties will have the option
to expand the collaboration to include a pivotal registration
study. Additional details of the collaboration were not
disclosed.
BL-8040, BioLineRx's lead oncology platform, is a CXCR4
antagonist that has been shown in several clinical trials to be a
robust mobilizer of immune cells and to be effective at inducing
direct tumor cell death. Additional findings in the field of
immuno-oncology suggest that CXCR4 antagonists may be effective in
inducing the migration of anti-tumor T cells into the tumor
micro-environment. Atezolizumab is a humanized monoclonal antibody
designed to bind with a protein called PD-L1. Atezolizumab is
designed to bind to PD-L1 expressed on tumor cells and
tumor-infiltrating immune cells, blocking its interactions with
both PD-1 and B7-1 (CD80) receptors. By inhibiting PD-L1,
Atezolizumab may enable the activation of T cells, whose migration
into the tumor may be enhanced by BL-8040.
"This collaboration agreement in multiple cancer indications
with Genentech marks our second collaboration with a world leader
in cancer immunotherapy for the combination of BL-8040 with an
approved immune checkpoint inhibitor," stated Philip Serlin, Chief Financial and Operating
Officer of BioLineRx. "Immune checkpoint inhibitors are a new class
of promising drugs that have revolutionized anti-cancer treatment;
however, it is becoming clear that certain tumor types will require
a combination of immunotherapy with other classes of drugs. We are
hopeful that the combination of BL-8040 and Atezolizumab will
demonstrate the potential to expand the benefit of immunotherapy to
cancer types currently resistant to cancer immunotherapy
treatments."
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.
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, is in the midst of a Phase 2b
study as an AML consolidation treatment, and has recently initiated
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) to run a Phase 2a study in pancreatic
cancer using the combination of BL-8040 and Merck's
KEYTRUDA®; and has recently signed a collaboration
agreement with Genentech, a member of the Roche Group, to
investigate several Phase 1b combination studies in multiple solid
tumor indications and AML using the combination of BL-8040 and
Genentech's Atezolizumab.
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 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 actual results,
performance or achievements 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"
sections of recent annual reports filed by the parties to this
release. In addition, any forward-looking statements represent the
parties' views only as of the date of this release
and should not be relied upon as representing their views as of any
subsequent date. The parties do 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
or
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.