TEL AVIV, Israel, November 20, 2017 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage
biopharmaceutical company focused on oncology and immunology,
announced today that an abstract with partial results from the
monotherapy portion of BL-8040's Phase 2a COMBAT study in
pancreatic cancer was accepted for presentation at the ASCO 2018
Gastrointestinal Cancers Symposium, to take place January 18-20, 2018 in San Francisco, CA.
The Phase 2a study, named the COMBAT study, is an open-label,
multicenter, single-arm trial designed to evaluate the safety and
efficacy of the combination of BL-8040 and KEYTRUDA®
(pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co.,
Inc., (known as MSD outside the United
States and Canada), in up
to 30 subjects with metastatic pancreatic adenocarcinoma. The study
is primarily designed to evaluate the clinical response, safety and
tolerability of the combination of these therapies. In addition,
the study will evaluate multiple pharmacodynamic parameters,
including the ability to improve infiltration of T cells into the
tumor and their reactivity, for both BL-8040 as a monotherapy, as
well as for the combination of BL-8040 and KEYTRUDA. The study is
being conducted in the US, Israel
and additional territories.
"We are very pleased that the abstract presenting our partial
monotherapy results for the COMBAT study were accepted to this
important clinical conference. Because of the embargo policy of the
conference, we won't be able to share the data by the end of the
year, but rather disclose it in January
2018, when the abstracts are released," commented
Philip Serlin, Chief Executive
Officer of BioLineRx. "As for today, we can report that enrollment
of the study has been completed and we are meeting our timelines
for conclusion of the study and topline results by the second half
of 2018. We are excited about the upcoming topline results in 2018,
and continue to fully support our development plan in combination
with immune checkpoint inhibitors".
In September 2016, BioLineRx
announced the initiation of the COMBAT study, its first Phase 2a
study for evaluating the clinical efficacy of BL-8040 in
combination with KEYTRUDA, for the treatment of patients with
metastatic pancreatic cancer who relapse to previous therapies. The
COMBAT study is being conducted by BioLineRx under a collaboration
agreement between BioLineRx and MSD, through a subsidiary, to
support a Phase 2a study investigating BioLineRx's BL-8040 in
combination with KEYTRUDA in patients with metastatic pancreatic
cancer.
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 infiltration of anti-tumor T cells into the tumor.
Therefore, when combined with KEYTRUDA, which blocks the
interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby
activating T lymphocytes which may affect tumor cells survival,
BL-8040 has the potential to enable activated larger amount of T
cells to better reach tumor cells in the fight against pancreatic
cancer.
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 and immune-cells from
the bone marrow, thereby sensitizing cancer cells to chemo- and
bio-based anti-cancer therapy, as well as a direct anti-cancer
effect by inducing cell death (apoptosis) and mobilizing
immune-cells. 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 (tradename of Merck
& Co., Inc.), on the basis of which the Company has initiated a
Phase 2a study in pancreatic cancer using the combination of
BL-8040 and MSD'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.
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.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.
Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-646-863-6274
vivian@pcgadvisory.com
Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.