BERGEN, Norway, Jan. 04, 2019 /PRNewswire/ -- BerGenBio ASA
(OSE: BGBIO), announces that the first patient has been dosed in an
investigator-initiated phase II trial of bemcentinib, a selective,
potent and orally bio-available AXL inhibitor, in patients with
high-risk myelodysplastic syndrome (MDS) who have failed first-line
treatment with hypomethylating agents. The trial may also enrol a
proportion of patients with acute myeloid leukaemia (AML). The
study is being sponsored by GWT-TUD GmbH (a specialist cancer
clinical research institution associated with the University of
Dresden, Germany) with the support
of BerGenBio.
The trial (BGBIL009 / BERGAMO) aims to confirm the
efficacy of bemcentinib monotherapy in patients with
high-risk MDS and AML and will enrol up to 43 patients at 8
hospitals in Germany, France, the
Netherlands and Italy. The study will allow for the
evaluation of potential predictive and pharmacodynamic biomarkers
for MDS in bone marrow and blood, including those associated
with patient benefit from bemcentinib.
Prof. Uwe Platzbecker, lead
investigator of the trial and director of the Medical Clinic and
Policlinic 1, Hematology and Cell Therapy at the University
Hospital in Leipzig, Germany,
commented: "As treatment of MDS and AML has not changed
significantly over the past decades, novel therapies are urgently
needed. The survival is still dismal, especially in elderly
patients who are not eligible for allogeneic stem cell
transplantation and who have failed first line treatment with
hypomethylating agents. AXL, a member of the Tyro3, AXL, Mer (TAM)
receptor family, mediates proliferation and survival of leukemic
cells and is upregulated upon cytostatic treatment. Pre-clinical
studies with the inhibitor bemcentinib demonstrated in
vitro and in mouse models that leukaemic proliferation was
blocked by interference with AXL signalling. Hence, AXL represents
a promising new target for the patient population investigated in
the BERGAMO trial."
Richard Godfrey, Chief
Executive Officer of BerGenBio, added: "We are very pleased
that Prof. Platzbecker and GWT-TUD are initiating this study, which
if positive will add valuable information on bemcentinib's
monotherapy use in a larger leukaemia population and provide
support for our broader development plans for bemcentinib in these
indications. We look forward to reporting results as the trial
progresses."
About MDS
Myelodysplastic syndromes (MDS) are stem cell disorders
characterised by a decreased ability of the bone marrow to produce
normal blood cells and platelets. MDS is associated with increased
risk of developing AML and immune dysfunctions are seen in patients
both with lower and higher-risk MDS. Drugs that modify
immunological responses can improve blood values and prolong
survival in some patients. Thus far, however, the only curative
treatment for MDS remains stem cell transplantation. Hence, there
is an urgent need for novel therapies to treat MDS.
About AXL
AXL kinase is a cell membrane receptor and an essential mediator
of the biological mechanisms underlying aggressive and
life-threatening diseases. In cancer, AXL drives tumour survival,
treatment resistance and spread, as well as suppressing the body's
immune response to tumours. AXL expression has been established as
a negative prognostic factor in many cancers. AXL inhibitors,
therefore, have potential value at the centre of cancer combination
therapy, addressing significant unmet medical needs and multiple
high-value market opportunities.
About Investigator-sponsored trials
Investigator-sponsored clinical trials are clinical trials
proposed by front-line patient-facing physicians who act as the
regulatory sponsor and are supported by industry in bespoke
clinical development partnerships. The industry partner does not
assume the role of sponsor according to European or US regulatory
guidelines but may offer support in a variety of different ways,
such as providing investigational medicinal product at no cost.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused
on developing transformative drugs targeting AXL as a potential
cornerstone of therapy for advanced and aggressive cancers.
The company's proprietary lead candidate, bemcentinib (formerly
known as BGB324), is a potentially first-in-class selective AXL
inhibitor in a broad phase II clinical development programme.
Ongoing clinical trials are investigating bemcentinib in multiple
solid and haematological tumours, in combination with current and
emerging therapies (including immunotherapies, targeted therapies
and chemotherapy), and as a single agent.
In parallel, BerGenBio is developing companion diagnostics test
to identify patient populations most likely to benefit from
bemcentinib; this is expected to facilitate more efficient
registration trials and support a precision medicine-based
commercialisation strategy.
BerGenBio is based in Bergen,
Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo
Stock Exchange (ticker: BGBIO).
www.bergenbio.com
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47-917-86-304
Rune Skeie
CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47-917-86-513
Media Relations in Norway
Jan Petter Stiff
Crux Advisers
stiff@crux.no
+47-995-13-891
International Media Relations
David Dible, Mark Swallow, Marine
Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
Forward looking statements
This announcement may contain forward-looking statements,
which as such are not historical facts, but are based upon various
assumptions, many of which are based, in turn, upon further
assumptions. These assumptions are inherently subject to
significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and
other important factors could cause actual events to differ
materially from the expectations expressed or implied in this
announcement by such forward-looking statements.
This information is subject to the disclosure requirements
pursuant to section 5-12 of the Norwegian Securities Trading
Act.
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/bergenbio-asa/r/bergenbio-announces-start-of-phase-ii-investigator-initiated-trial-evaluating-selective-axl-inhibito,c2711097
View original
content:http://www.prnewswire.com/news-releases/bergenbio-announces-start-of-phase-ii-investigator-initiated-trial-evaluating-selective-axl-inhibitor-bemcentinib-in-high-risk-mds-300772860.html
SOURCE BerGenBio ASA