BERGEN, Norway, 13 April, 2018 /PRNewswire/ --
BerGenBio ASA (OSE: BGBIO) announces that promising pre-clinical
data demonstrating that selective AXL inhibition counteracts the
progression of aggressive fibrosis in the lung and liver has been
published in the international peer-reviewed journal American
Journal of Respiratory and Critical Care Medicine (AJRCCM, (1)) and
accepted for presentation at the 53rd annual meeting of the
European Association for the Study of the Liver (EASL),
respectively.
Additionally, pre-clinical data of BerGenBio's out-licensed
AXL ADC candidate BGB601 has been
accepted for presentation at the American Association for Cancer
Research (AACR) Annual Meeting 2018.
The details of the publications are as follows:
Potential of selective AXL inhibition as a mechanism for
treating the progressive, rare, and frequently fatal lung disease
idiopathic pulmonary fibrosis (IPF):
Milena Espindola and colleagues
from Cedars-Sinai in Los Angeles,
CA, published evidence in the American Journal of
Respiratory and Critical Care Medicine (AJRCCM) that AXL receptor
expression is significantly elevated in patient cells, tissues and
models of IPF. Consistent with the pathological role of AXL in
fibrosis, selective inhibition of AXL using bemcentinib (BGB324)
impacted IPF fibroblast functions and the development of fibrosis
in pre-clinical models of IPF. The data also show a clear
distinction in AXL levels between fast and slow progressing IPF
patients, highlighting the potential of using AXL levels as a
biomarker to (i) identify patients with a poor prognosis and who
may respond to treatment with an AXL inhibitor, and (ii) enrich
patient populations in future clinical trials.
The article in press is entitled: "Targeting of TAM Receptors
Ameliorates Fibrotic Mechanisms in Idiopathic Pulmonary
Fibrosis" and can be accessed at the AJRCCM's website - click
here.
Potential of selective AXL inhibition for treating advanced
form of non-alcoholic steatohepatitis (NASH)
Anna Tutusaus et al. will be presenting a poster on AXL
targeting in NASH entitled "AXL increase in NASH patients and
anti-fibrotic efficacy of AXL inhibition in experimental NASH"
(abstract: FRI-074) at the European Association for the Study of
the Liver (EASL) Annual Meeting in Paris,
France, on Friday 13 April between 9
and 17:00 CET.
The abstract is available online - click here.
Pre-clinical data in models of aggressive, AXL expressing,
tumours supporting clinical development of AXL ADC BGB601 (ADCT-601)
Lorenzo Zammarchi et
al. will be presenting a poster on the in vitro and
in vivo anti-tumour activity of BGB601 (ADCT-601) in human
cancer cell lines and animal models as well as data on its safety
and tolerability entitled "Preclinical activity of ADCT-601, a
novel pyrrolobenzodiazepine (PBD) dimer-based antibody-drug
conjugate (ADC) targeting AXL-expressing tumors" (abstract:
2792A) at the American Association of Cancer Research (AACR) Annual
Meeting in Chicago, IL, on Monday
16 April between 13:00 and 17:00
CDT.
The abstract is available online at the AACR Annual Meeting
website – click here.
Richard Godfrey, CEO of
BerGenBio commented: "This patient data and pre-clinical
findings in IPF and cirrhotic NASH are very compelling and suggest
that selective AXL inhibition may have potential as a new approach
to treating life-threatening fibrotic diseases. While our focus
remains clearly on completing our phase II clinical programme with
bemcentinib and to establish proof of concept for its role as a
cornerstone of cancer therapy, we are intrigued by the possibility
of therapeutic benefit from our AXL inhibitors in fibrotic
diseases. We will continue to support this research and look
forward to integrating it into our pipeline development strategies.
Furthermore, we are encouraged by pre-clinical data supporting the
advancement of BGB601, our out-licensed AXL
ADC drug candidate, towards the clinic."
About fibrosis, IPF and NASH
Fibrosis is an exaggerated healing response that fails to
terminate appropriately causing almost half of fatalities across
all non-communicable diseases combined.
Idiopathic Pulmonary Fibrosis (IPF) is a severe, progressive
disease characterised by fibrosis in the lung. Approximately 12 in
100,000 people will develop IPF each year, the current approved
treatments may slow down progression of the disease but are not
curative. Prognosis for those diagnosed with IPF is poor, with
median survival of only 2-3 years (2).
Non-alcoholic steatohepatitis (NASH) is a type of fatty liver
disease characterised by fibrosis, inflammation and liver cell
damage for which there is no approved treatment. Across the US and
EU5, approximately 25 million people are believed to have NASH – a
proportion of whom will experience significant worsening of their
condition eventually leading to fatal liver failure.
About BGB601 (ADCT-601)
BGBC601 (ADCT-601) is an Antibody Drug Conjugate (ADC) drug,
composed of a humanised IgG1 antibody against human AXL, discovered
at BerGenBio and out-licensed for further development by ADC
Therapeutics SA.
About the EASL and AACR Annual Meetings
The EASL Annual Meeting is the largest congress dedicated to
hepatology. 10,000 international delegates from a wide range of
scientific disciplines gather to present the latest research at
this highly regarded event. The 2018 EASL Annual meeting will take
place in Paris, France, 11 - 15
April. For more information please visit:
https://ilc-congress.eu.
The AACR is the largest professional organisation in the world
dedicated to advancing cancer research and its mission to prevent
and cure all cancers. During the 2018 annual meeting, thousands of
oncology researchers and clinicians will gather in Chicago, IL, April
14 – 18. For more information, please visit:
http://www.aacr.org
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
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.
References
(1) Espindola MS et al AJRCC 2018
(2) Raghu G et al AJRCCM 2011
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.
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
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