- Encouraging clinical data emerging from several
phase II trials with highly selective AXL inhibitor bemcentinib
(BGB324)
- Advanced lung cancer (NSCLC): First stage fully
recruited, and first efficacy endpoint met in phase II trial
of bemcentinib in combination with anti-PD-1 therapy
KEYTRUDA®
- Advanced leukaemia (AML/MDS): Encouraging
bemcentinib single agent activity in hard to treat relapsed /
refractory (R/R) leukaemia
- Pipeline update: AXL antibody preparing for
Phase I clinical trial
BERGEN , Norway, 21 Aug, 2018 /PRNewswire/ -- BerGenBio ASA (OSE:
BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for multiple cancer
indications, announces its results for the second quarter and first
half 2018. A presentation of the results by the Company's
management will take place today at 10.00 am
CET in Oslo – details
below.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "We are pleased
with the progress of our clinical development programme for
bemcentinib in the first half 2018. The emerging results in several
clinical trials, which we showcased at our successful satellite
reception coinciding with the ASCO meeting in June, are very
encouraging and continue to support our view that bemcentinib could
become a cornerstone of future cancer therapy. These data provide
further evidence of bemcentinib's activity in patients whose cancer
progression is mediated by AXL. In addition, we are making good
progress with our studies to identify predictive biomarkers that
could be developed as companion diagnostics for personalized
therapy with bemcentinib. We look forward to advancing these
studies to completion and defining the future development strategy
of bemcentinib with the greatest value for patients."
Highlights – Second Quarter & First Half 2018
- Advanced lung cancer (NSCLC): First stage fully
recruited, and first efficacy endpoint met in trial of
bemcentinib in combination with KEYTRUDA®. Clinical responses seen
following treatment with bemcentinib/KEYTRUDA in patients negative
for PD-L1 for whom KEYTRUDA monotherapy is not effective.
- Advanced leukaemia (AML/MDS): Encouraging single agent
activity in hard to treat relapsed / refractory (R/R) leukaemia:
Superior response rates of > 40% observed in biomarker subgroup
analyses.
- Triple negative Breast cancer (TNBC): First stage fully
recruited, patients negative for Axl and PDL1 and first efficacy
endpoint not met.
- Tissue- and blood-based biomarkers with potential for
development as companion diagnostics: AXL IHC method reporting
encouraging correlation data. Low plasma soluble AXL predicts
patient benefit in R/R AML/MDS.
- Pipeline update: AXL antibody preparing for Phase I
clinical trial.
- Cash position NOK441m.
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take
place at 10.00 am CET at:
Felix Konferansesenter, Bryggetorget 3, 0125 Oslo
The presentation will webcast live and the link will be
available at www.bergenbio.com in the section Investors/ Financial
Reports. A recording will be available shortly after the webcast
has finished.
The results report and the presentation will be available at
www.bergenbio.com in the section: Investors/ Financial Reports from
7:00 am CET the same day.
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 aggressive disease,
including immune evasive, drug resistant, metastatic 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
commercialization 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
International Media Relations
David Dible
Mark Swallow
Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
Media relations in Norway
Jan
Petter Stiff
Crux Advisers
stiff@crux.no
+47-995-13-891
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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The following files are available for download:
http://mb.cision.com/Main/15728/2596612/894708.pdf
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http://mb.cision.com/Public/15728/2596612/bed70f9739dd8233.pdf
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BGBIO 2018 Q2 Report
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http://mb.cision.com/Public/15728/2596612/a1707246f725dfd2.pdf
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BGBIO 2018 Q2
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