BERGEN, Norway,
April 10, 2018 /PRNewswire/ --
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical
company developing novel, selective AXL kinase inhibitors as a
potential cornerstone of combination cancer therapy in NSCLC,
AML/MDS, TNBC and melanoma, announces that it has completed
enrolment of the planned 22 patients into the first stage of its
Phase II clinical trial evaluating bemcentinib (formerly BGB324),
its investigational oral selective AXL inhibitor, in combination
with the Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside
the United States and Canada) anti-PD-1 therapy KEYTRUDA®
(pembrolizumab) as a potential new treatment regimen for advanced
lung cancer.
The Phase II trial (BGBC008) follows a two-stage design: it is
an open label, multi-centre study of bemcentinib in combination
with KEYTRUDA in patients with previously treated advanced
adenocarcinoma of the lung (non-small cell lung cancer, NSCLC)
whose disease is progressing. Up to 48 patients in total will be
included in the study (NCT03184571).
The trial is designed to evaluate the anti-tumour activity,
objective response rate and safety of the combination, and to
correlate the patient response with biomarker status (including AXL
kinase and PD-L1 expression). In parallel, companion diagnostics
using these and other biomarkers are being developed for the
identification of patients predicted to be most suitable for
treatment with the bemcentinib / KEYTRUDA combination. Interim
results are expected during 2018.
The trial, which began in October
2017, is being conducted under a clinical collaboration with
Merck & Co., Inc., Kenilworth,
N.J., USA, through a subsidiary, and is taking place at more
than 12 clinical sites in the US, UK, Norway and Spain.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "Immuno-oncology
therapies, such as KEYTRUDA, are now established as a major
treatment option for lung cancer patients alongside targeted and
chemo-therapies. This trial forms an important part in our strategy
to provide proof of concept that selective AXL inhibition in
combination with established and emerging cancer therapies may
improve patient outcomes. We are encouraged by strong pre-clinical
data combining bemcentinib with immune-therapy to increase and
deepen responses as well as early clinical data suggesting that
bemcentinib in combination with KEYTRUDA has a favourable safety
profile across several cancer indications. We are looking forward
to report interim results from the BGBC008 trial as well as our
other combination trials in the coming months.
About NSCLC
It is estimated that more than 220,000 new cases of lung cancer
were diagnosed in the US in 2017 and it is the leading cause of
cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology.
Although various treatments exist for NSCLC, they are often
curtailed by acquired resistance to therapy and immune evasion.
Novel treatments overcoming these mechanisms in NSCLC are urgently
required.
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company
focused on developing a pipeline of first-in-class AXL kinase
inhibitors as a potential cornerstone of combination cancer
therapy. The Company is a world leader in understanding the
essential role of AXL kinase in mediating cancer spread, immune
evasion and drug resistance in multiple aggressive solid and
haematological cancers.
BerGenBio's lead product, bemcentinib (BGB324), is a selective,
potent and orally bio-available small molecule AXL inhibitor in
four Company sponsored Phase II clinical trials in major cancer
indications, with read-outs anticipated during 2018. It is the only
selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:
- Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation
driven non-small cell lung cancer (NSCLC)
- Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the
lung, and
- Bemcentinib with KEYTRUDA in triple-negative breast cancer
(TNBC).
- Bemcentinib as a single agent and combination therapy in acute
myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
The clinical trials combining bemcentinib with KEYTRUDA in
adenocarcinoma of the lung and TNBC are conducted in collaboration
with Merck & Co., Inc., Kenilworth,
NJ, USA, through a subsidiary.
In addition, a number of investigator-sponsored trials are
underway, including a trial to investigate bemcentinib with either
MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in
advanced melanoma, as well as a trial combining bemcentinib with
docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic
test to identify patient subpopulations most likely to benefit from
treatment with bemcentinib. This will facilitate more efficient
registration trials and support a precision medicine based
commercialisation strategy.
The Company is also developing a diversified pre-clinical
pipeline of drug candidates, including BGB149, an anti-AXL
monoclonal antibody.
For further information, please visit:
www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. TARCEVA® is a registered
trademark of OSI Pharmaceuticals, LLC., marketed by
Roche-Genentech. TAFLINAR® is a registered trademark of
Novartis International AG and MEKINIST® is a registered trademark
of GSK plc.
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
Advisors
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.
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