TEL AVIV, Israel, June 1, 2017 /PRNewswire/ --
-
Genentech has submitted
all three solid tumor trials
planned underits
cancer immunotherapy collaboration with
BioLineRx -
- Studies will
investigate the combination in pancreatic
cancer, gastric cancer and
non-small cell lung cancer (NSCLC)
-
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
filed a total of three regulatory submissions required to commence
Phase 1b trials for BL-8040 in combination with atezolizumab
(Tecentriq®), Genentech's anti-PDL1 cancer
immunotherapy, for the treatment of patients with solid tumors. The
trials for pancreatic, gastric and non-small cell cancer are
expected to commence during the second half of 2017, after receipt
of regulatory approval.
These clinical studies are part of a cancer immunotherapy
collaboration between BioLineRx and 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 studies
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 clinical trials to be a robust
mobilizer of immune cells and to be effective in 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, 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.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "The completion of all three
regulatory submissions by our partner, Genentech, for the
combination studies of our CXCR4 inhibitor lead oncology platform
and their anti-PD-L1 immune checkpoint inhibitor, is a testimony to
the commitment on the part of both companies to advance our
collaboration and establish new treatments for the potential
benefit of cancer patients. This follows our recently announced
regulatory filing of the same combination for the treatment of AML
patients. Our clinical collaboration with Genentech is advancing on
track, and we look forward to the initiation of these multiple
clinical studies."
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) 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
Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.