TEL AVIV, Israel, March 20, 2017 /PRNewswire/ --
- Results to date
confirm that single injection of
BL-8040 mobilizes
sufficient amounts of cells required
for allogeneic
transplantation without need for G-CSF
-
-
Top-line results
expected by end of
2017 -
BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage
biopharmaceutical company focused on oncology and immunology,
reported partial results data from its open-label Phase 2 trial for
BL-8040 as a novel monotherapy approach for the mobilization and
collection of blood forming stem and progenitor cells from the
peripheral blood.
The study consists of donor and patient pairs for allogeneic
hematopoietic cell transplantation. The first part of the study,
which is nearing completion, is intended to enroll an initial
cohort of 10 donor and recipient pairs, consisting of patients with
advanced hematological malignancies and their HLA-matched sibling
donors. Interim results show that a single injection of BL-8040
mobilized sufficient amounts of cells required for transplantation
at a level of efficacy similar to that achieved by using 4-6
injections of G-CSF, the current standard of care. Furthermore, all
recipients transplanted so far have experienced a successful
neutrophil engraftment. The recipients will be followed for one
year to assess acute and chronic GVHD events. As for the donors,
BL-8040 treatment was safe and well tolerated.
Philip Serlin, Chief Executive
Officer of BioLineRx, stated, "We are very encouraged by these
initial results of the Phase 2 clinical trial for assessing
BL-8040, our lead oncology and hematology platform, as a single
agent for hematopoietic stem cell mobilization for allogeneic
transplantation. Hematopoietic stem cells are increasingly used as
part of the treatment regimen for certain types of hematological
cancers, as well as for severe anemia and immune deficiency
disorders. These results, supporting BL-8040 as a one-day dosing
and up-to-two-day collection regimen, for rapid mobilization of
substantial amounts of stem cells, represent a significant
improvement over the current standard of care, which requires
four-to-six daily injections of G-CSF and one-to-four apheresis
sessions. If there are no safety concerns regarding graft
failure or rejection after the interim safety review of
donor-recipient pairs participating in Part 1 of the study, we will
continue with Part 2 of the study, which will permit enrollment of
recipients with either matched sibling or haploidentical donors, up
to a total enrollment in the study of 24 donor-recipient pairs. We
are looking forward to the topline results expected by the end of
2017."
"We continue our efforts to maximize the potential of our unique
BL-8040 oncology platform, with multiple clinical studies for
additional indications up and running or expected to start in 2017,
including several combination studies with immune checkpoint
inhibitors and a registration study in stem-cell mobilization for
autologous transplantation," added Mr. Serlin.
The Phase 2 open-label study is conducted in collaboration with
the Washington University School of
Medicine, Division of Oncology, and will enroll up to 24
donor/recipient pairs, aged 18-70. The trial is designed to
evaluate the ability of BL-8040, as a single agent, to promote stem
cell mobilization for allogeneic hematopoietic cell
transplantation. On the donor side, the primary endpoint of the
study is the ability of a single injection of BL-8040 to mobilize
sufficient amounts of cells for transplantation following up to two
apheresis procedures. On the recipient side, the study aims to
evaluate the time to engraftment rate following transplantation of
the BL-8040 collected graft.
The study will also evaluate the safety and tolerability of
BL-8040 in healthy donors, as well as graft durability, the
incidence of grade 2-4 acute and chronic GVHD, and other recipient
related parameters in patients who have undergone transplantation
of hematopoietic cells mobilized with BL-8040.
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 Stem Cell Mobilization
High-dose chemotherapy followed by hematopoietic cell
transplantation has become an established treatment modality for a
variety of hematologic malignancies, including multiple myeloma, as
well as various forms of lymphoma and leukemia. Modern peripheral
stem-cell harvesting often replaces the use of traditional surgical
bone marrow stem-cell harvesting. In the modern method, stem cells
are mobilized from the bone marrow using granulocyte
colony-stimulating factor (G-CSF), often with the addition of a
mobilizing agent such as Plerixafor (Mozobil), harvested from the
donor's peripheral blood by apheresis, and infused to the patient
after chemotherapy ablation treatment.
An allogeneic hematopoietic cell transplant involves matching a
patient's tissue type, specifically their human leukocyte antigen
(HLA) tissue type, with that of a related or unrelated donor. HLA
proteins are found on all cells of our body and are the main way
the immune system tells the difference between our own cells and
foreign cells. The closer the HLA match between a donor and
recipient, the greater the chance a transplant will be successful.
If the HLA match is not close enough, the donor's immune system,
which accompanies the donated stem cells, recognizes the HLA
mismatch, and will attack the recipient's tissues. This process is
known as graft versus host disease (GVHD).
Approximately 70% of people with a hematological malignancy or
bone marrow failure syndrome who need an allogeneic transplant have
an HLA-identical sibling or unrelated donor available. For patients
who need a stem cell transplant but do not have an HLA-matched
related or unrelated donor, recent medical advances have made
possible the use of a partially matched or haploidentical related
donor. A haploidentical related donor is usually a 50% match to the
recipient and may be the recipient's parent, sibling or child.
The advantage of having a haploidentical transplant is
that it increases the chance of finding a donor as
almost everyone has at least one haploidentical relative. Relatives
can usually be asked to donate stem cells much more quickly than
unrelated volunteer donors, particularly when the volunteer donors
live in other countries, thereby allowing transplants to be done in
a more timely manner.
With improvements in medical treatment, complications of a
haploidentical transplant, such as GVHD, rejection of the graft and
slow recovery of the immune system appear not to be increased
compared to transplants using HLA-matched related or unrelated
donors. Since this is a relatively new approach to stem cell
transplantation, a haploidentical transplant is a treatment option
that is not offered at all treatment centers, but is becoming more
common.
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused
on oncology and immunology. 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 and is in the midst of a Phase
2b study as an AML consolidation treatment and 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), 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, 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.
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 10, 2016. 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.