Regulatory Filings • Mar 8, 2017
Regulatory Filings
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BerGenBio enters collaboration with MSD focused on clinical evaluation of BGB324 in combination with KEYTRUDA® (pembrolizumab) in advanced lung and breast cancer
Bergen, Norway, 8 March 2017: BerGenBio ASA, a clinical-
stage biopharmaceutical company developing novel, selective
Axl kinase inhibitors for multiple cancer indications,
announces it has entered into a collaborative agreement with
Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside
the US and Canada) , through a subsidiary, focused on the
clinical evaluation of BGB324 with KEYTRUDA® (pembrolizumab)
in patients with advanced non-small cell lung cancer (NSCLC)
and triple-negative breast cancer (TNBC).
BerGenBio's lead candidate BGB324 is a first in class,
highly selective, potent and orally available small molecule
Axl kinase inhibitor in clinical development in a variety of
cancer indications. The Axl tyrosine kinase is a key driver
of cancer spread, immune evasion and drug resistance - the
cause of the majority of cancer-related deaths. Increased
understanding of the role of Axl in suppressing innate
immunity supports the rationale for evaluating BGB324 in
combination with KEYTRUDA.
Under the terms of the collaboration with MSD, BerGenBio
will conduct two international Phase II studies to evaluate
the potential clinical synergy of combining BGB324 with
MSD's anti-PD-1 therapy, KEYTRUDA. Details of the studies
are as follows:
BGBC007 - A Phase II multi-centre study of BGB324 in
combination with KEYTRUDA in patients with previously
treated, locally advanced or unresectable TNBC.
BGBC008 - A Phase II multi-centre study of BGB324 in
combination with KEYTRUDA in patients with previously
treated unresectable adenocarcinoma of the lung.
Biomarker studies will be conducted in parallel to the above
studies with the goal of developing companion diagnostics to
identify patients who would be most suitable for treatment
with the BGB324/KEYTRUDA combination.
The clinical trials will be sponsored by BerGenBio while MSD
will provide the trial with KEYTRUDA. The rights to the
study results will be shared. No further details are
disclosed.
BerGenBio is investigating BGB324 in multiple cancer
indications based on preclinical and early clinical
findings. Phase II studies with BGB324 as a single agent in
relapsed acute myeloid leukaemia (AML) and myeloid
dysplastic syndrome (MDS); and in combination with erlotinib
(TARCEVA®) in advanced EGFR-positive NSCLC are in progress.
Richard Godfrey, Chief Executive Officer of BerGenBio,
commented: "We are delighted to enter this collaboration
with MSD, a leader in developing novel cancer therapies.
This new agreement gives us the opportunity to evaluate the
clinical potential of BGB324 in combination with KEYTRUDA in
advanced lung and breast cancer; two of the areas of
significant unmet medical need. We believe that BGB324 is a
unique drug candidate that addresses a critical cancer
mechanism responsible for promoting immune evasion. We
believe the clinical utility of BGB324 in combination with
immunotherapies has enormous potential. BerGenBio is excited
to advance BGB324 in combination with KEYTRUDA into Phase II
trials and we anticipate results in mid-2018."
About BerGenBio ASA
BerGenBio (Bergen, Norway) is a clinical-stage
biopharmaceutical company focused on developing a
pipeline of first-in-class Axl kinase inhibitors to treat
multiple cancer indications. The Company is a
world leader in understanding the central role of Axl kinase
in promoting cancer spread, immune
evasion and drug resistance in multiple aggressive liquid
and solid cancers.
BerGenBio's lead product, BGB324, is a selective, potent and
orally available small molecule Axl
inhibitor in Phase II clinical development in three major
cancer indications. It is the only selective Axl
inhibitor in clinical development. BGB324 is being developed
by BerGenBio as a single agent therapy
in acute myeloid leukaemia (AML)/myeloid dysplastic syndrome
(MDS) and in combination with
TARCEVA® (erlotinib) in advanced non-small-cell lung cancer
(NSCLC); and in combination with
KEYTRUDA® (pembrolizumab) in advanced NSCLC and triple
negative breast cancer (TNBC) in
collaboration with MSD.
The Company is also developing a diversified pre-clinical
pipeline of selective Axl inhibitors including
BGB149, anti-Axl monoclonal antibody.
For further information, please visit: www.bergenbio.com
About NSCLC
About NSCLS
It is estimated that more than 220,000 new cases of lung
cancer will be diagnosed in the US in 2017
and it is the leading cause of cancer death. 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 TNBC
About TNBC
Breast cancer is the most common cancer in women - it is
estimated that more than 250,000 new
cases will be diagnosed in the US in 2017. 20% of breast
cancers lack receptors for three common
hormones (estrogen, progesterone and HER2) and are thus
called triple-negative breast cancers
(TNBC). Treatment options for TNBC are limited to intense
chemotherapy, but despite therapy
recurrences are frequent and aggressive. Consequently, novel
treatment strategies for TNBC are of
high need.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co.,
Inc. TARCEVA® is a registered trademark of OSI
Pharmaceuticals, LLC.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
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