TEL AVIV, Israel, Jan. 17, 2018 /PRNewswire/
-- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a
clinical-stage biopharmaceutical company focused on oncology and
immunology, announced today partial results from the monotherapy
portion of BL-8040's Phase 2a COMBAT study showing that BL-8040
increases infiltration of T cells into the tumor in patients with
metastatic pancreatic cancer. The data will be presented as a
poster titled "Evaluation of Pharmacodynamic Biomarkers in Patients
with Metastatic Pancreatic Cancer Treated with BL-8040, a Novel
CXCR4 Antagonist (Abstract 276)" at the ASCO 2018 Gastrointestinal
Cancers Symposium, on January 19,
2018 in San Francisco,
CA.
The partial results from the BL-8040 monotherapy portion of the
COMBAT trial show that BL-8040 was safe and well-tolerated. BL-8040
also induced an increase in the number of total immune cells in the
peripheral blood, while the frequency of peripheral blood
regulatory T cells (Tregs), known to impede the anti-tumor immune
response, was decreased. In addition, analysis of available
biopsies (N = 7) showed infiltration of various types of
effector T cells, known to attack cancer cells, into the tumor
periphery and tumor micro-environment (TME). In this regard, the
results show up to a 15-fold increase in CD3+ T cells, and up to a
2-fold increase in CD8+ T cells, in the TME of 43% (3/7) of the
patients, after five days of BL-8040 monotherapy.
Dr. Manuel Hidalgo, Chief of
Hematology Oncology and Co-Director of the Pancreatic Cancer
Research Program at Beth Israel Deaconess Medical Center in
Boston, commented, "This is the
first time we see results of BL-8040 in pancreatic cancer patients.
The results of the monotherapy part of the COMBAT trial are
extremely encouraging as they confirm the mechanism of action of
BL-8040 in this difficult-to-treat patient population, resulting in
T-cell infiltration into the tumor after only 5 days of monotherapy
with BL-8040. These results support the rationale for combining
BL-8040 with checkpoint inhibitors, and I am looking forward to the
topline results of the COMBAT study expected later this year."
"The results show that BL-8040 induces robust infiltration of
anti-tumor T cells into liver metastases in almost half of the
pancreatic cancer patients who underwent a biopsy, effectively
transforming these tumors from immunologically 'cold' to 'hot',
which is seen as key in the objective of improving the
responsiveness of patients with pancreatic cancer to front-line
immunotherapy" stated Philip Serlin,
Chief Executive Officer of BioLineRx. "These results support the
mechanism of action proposed by pre-clinical studies, namely that
BL-8040 mobilizes immune cells into the peripheral blood and
promotes T cell infiltration into tumors. As previously reported,
enrollment of the study has been completed and we expect to meet
our timelines for conclusion of the study and topline results by
the second half of 2018."
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., Kenilworth, N.J., USA (known
as MSD outside the United States
and Canada), in over 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
evaluates multiple pharmacodynamic parameters, including the
ability to increase infiltration of T cells into the tumor, 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.
The COMBAT study is being conducted by BioLineRx under a
collaboration agreement signed in 2016 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 to peripheral blood and to be
effective at inducing direct tumor cell death. Additional findings
have suggested that CXCR4 antagonists may be effective at
increasing the infiltration of anti-tumor T cells into tumors that
were previously immunologically "cold" and devoid of immune cell
infiltrate. Checkpoint inhibitors (such as KEYTRUDA) produce
anti-cancer effects by increasing the activity of T cells through
blockade of the interaction between the immunosuppressive elements
PD-1, on T cells, and PD-L1, on tumor cells. Pancreatic cancers
have very little T-cell infiltrate, making them less susceptive to
checkpoint blockade than other tumors that are infiltrated by T
cells. Therefore, combining BL-8040 with checkpoint blockade is
predicted to increase the responsiveness of pancreatic cancer
patients to immunotherapy.
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 has recently initiated 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., Kenilworth, N.J., USA), 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 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.,
Kenilworth, N.J., USA.
Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-646-863-6274
vivian@pcgadvisory.com
or
Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com
View original
content:http://www.prnewswire.com/news-releases/biolinerx-announces-partial-monotherapy-results-from-phase-2a-combat-study-in-pancreatic-cancer-300583808.html
SOURCE BioLineRx Ltd