Environmental & Social Information • Jun 26, 2017
Environmental & Social Information
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BerGenBio Awarded NOK 24m from Innovasjon Norge to Support the Clinical Development of BGB324 in Combination with KEYTRUDA® for Advanced Lung Cancer
Bergen, Norway, June 26 2017 - BerGenBio ASA, a clinical-stage biopharmaceutical
company developing novel, selective Axl kinase inhibitors for multiple cancer
indications, is pleased to announce the award of a NOK 24 million (USD 2.85m)
grant from Innovasjon Norge to support the clinical development of BGB324 in
combination with Merck & Co.'s KEYTRUDA® (pembrolizumab) in patients with
advanced lung cancer. BerGenBio will sponsor a Phase II study multi-centre study
of BGB324 in combination with KEYTRUDA in patients with previously treated
unresectable adenocarcinoma of the lung.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are
delighted to have received this grant award, the largest grant from the
"Industrial Development" program ever made by Innovasjon Norge. BGB324 is a
novel small molecule Axl inhibitor that, as a one-a-day pill, offers an exciting
opportunity to treat multiple cancers through a potentially universal mechanism.
Axl signalling is a central process that promotes cancer cells to become
aggressive. By blocking Axl signalling, tumour cells revert to a stable state
where we believe they can be targeted and destroyed by the immune system and re
-sensitized to other cancer therapies. We believe therefore that BGB324 alone
and in combination with immunotherapies, such as KEYTRUDA, has the potential to
significantly improve the clinical outcomes in a broad range of cancers. We
anticipate announcing the results of this combination Phase II study in 2018."
The grant from Innovasjon Norge is an Industrial Development Award (IFU). The
IFU program is directed to Norwegian companies developing new products or
services in collaboration with foreign companies. The NOK 24 million grant will
contribute towards BerGenBio's costs of running this specific Phase II clinical
trial.
Director Nina Broch Mathisen of Innovasjon Norge, said: "We are pleased to have
made this very significant grant award to BerGenBio. We have been very impressed
by the innovation demonstrated by BerGenBio in a highly competitive global
market, in an industry within our defined area of focus. The clinical data that
has already been generated with BGB324, has convinced us to support the Phase II
study in advanced lung cancer patients assessing BGB324 in combination with
KEYTRUDA. We are optimistic that this study will contribute to value creation in
Norway, positively promote the Norwegian healthcare sector, and will offer
renewed hope to a large number of cancer patients."
In March 2017, BerGenBio entered into a collaborative agreement with Merck &
Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), focused
on the clinical evaluation of BGB324 with KEYTRUDA® in patients with advanced
non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
About BerGenBio ASA
BerGenBio ASA 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 essential
role of Axl kinase in mediating cancer spread, immune evasion and drug
resistance in multiple aggressive haematological and solid cancers.
BerGenBio's lead product, BGB324, is a selective, potent and orally bio
-available small molecule Axl inhibitor in Phase II clinical development in four
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). In advanced non-small
-cell lung cancer (NSCLC), BGB324 is tested in combination with TARCEVA®
(erlotinib) as well as TAXOTERE® (docetaxel) and KEYTRUDA® (pembrolizumab). In
advanced melanoma, combination of BGB324 with either MEKINIST® (trametinib) and
TAFINLAR® (dabrafenib) or KEYTRUDA® are being explored. A further combination of
BGB324 with KEYTRUDA® is being tested in triple negative breast cancer (TNBC).
The clinical trials combining BGB324 with KEYTRUDA® in NSCLC and TBNC are
conducted in collaboration with Merck & Co. Inc. (MSD).
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. TARCEVA® is a registered trademark of OSI Pharmaceuticals,
LLC., marketed by Roche-Genentech.
-Ends-
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
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