Regulatory Filings • Apr 13, 2018
Regulatory Filings
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Promising pre-clinical data supporting BerGenBio's pipeline to be published and presented at upcoming leading conferences
· Bemcentinib active in pre-clinical models of IPF and NASH
· IPF and cirrhotic NASH patients with aggressive disease identified by AXL
blood based biomarker
· BGB601 (partnered AXL ADC drug candidate) anti tumour pre-clinical data to
be presented at AACR.
Bergen, Norway, 13 April 2018 - 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 (http://www.atsjournals.org/doi/abs/10.1164/rccm.201707-1519OC).
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 (https://program.m
-anage.com/ProgramSearch/?eventName=ilc2018&language=en
-GB&searchString=axl&pProgramGrade=Scientific).
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 (http://www.abstractsonline.com/pp8/#!/4562/presentation/9909).
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."
-End-
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 (http://adctherapeutics.com).
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
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
+47 917 86 513
Media Relations in Norway
Jan Petter Stiff, Crux Advisors
+47 995 13 891
International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
+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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