BerGenBio Awarded NOK 24m from Innovasjon Norge to Support the Clinical Development of BGB324 in Combination with KEYTRUDA® for Advanced Lung Cancer

26.06.2017

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 (USD2.85m) 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
bergenbio@citigatedr.co.uk

+44 207 638 9571

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.