BerGenBio

Regulatory Filings • Nov 1, 2017

Clinical Study with BGB324, BerGenBio's Selective First-in-Class AXL Inhibitor, Featured at the 2017 American Society of Hematology Annual Meeting

Clinical Study with BGB324, BerGenBio's Selective First-in-Class AXL Inhibitor, Featured at the 2017 American Society of Hematology Annual Meeting

Bergen, Norway, 1 Nov 2017 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective Axl kinase inhibitors for

multiple cancer indications, announces that data and analysis from its Phase

Ib/II clinical trial with BGB324 in patients with acute myeloid leukaemia (AML)

and myelodysplastic syndrome (MDS), has been selected for presentation at the

59th ASH Annual Meeting and Exposition in Atlanta, USA (9-12 Dec 2017).

The presentation reports on the effect of BGB324 treatment on blood plasma

proteins and their relationship to treatment outcome, as a means of identifying

possible biomarkers for patient selection and the development of companion

diagnostics. Furthermore, the study highlights the unique immune-modulating

effects of BGB324 treatment as determined by diversification of the immune B-

and T- cell repertoires in AML patients, lending support to the strategy of AXL

inhibition as a means to combat tumour immune evasion.

Sonja Loges (MD, PhD), attending physician and professor at the Department of

Hematology and Oncology with Sections BMT and Pneumology, Hubertus Wald

Tumorzentrum, University Comprehensive Cancer Center Hamburg, University Medical

Center Hamburg-Eppendorf, Germany, will present The Orally Available Selective

Axl Inhibitor BGB324 Induces Diversification of the Immune Repertoire and

Specific Changes in Plasma Biomarker Profiles.

· Abstract ID#: 107092 - Georgia World Congress Center, Atlanta, GA, USA, 9-12

Dec 2017

· ClinicalTrials.gov identifier: NCT03184558

The abstract is now available online - http://www.hematology.org/Annual

-Meeting/.

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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 solid and haematological cancers.

BerGenBio's lead product, 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 in the

second half of 2018. It is the only selective Axl inhibitor in clinical

development.

The Company sponsored clinical trials are:

· BGB324 as a single agent and combination therapy in acute myeloid leukaemia

(AML) / myeloid dysplastic syndrome (MDS)

· BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small

cell lung cancer (NSCLC)

· BGB324 with KEYTRUDA® (pembrolizumab) in advanced adenocarcinoma of the

lung, and

· BGB324 with KEYTRUDA in triple negative breast cancer (TNBC).

The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung

and TNBC are conducted in collaboration with Merck & Co. Inc. (MSD).

In addition, a number of investigator-sponsored trials are underway, including a

trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR®

(dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining

BGB324 with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify

patient subpopulations most likely to benefit from treatment with BGB324. This

will facilitate more efficient registration trials and support a precision

medicine based commercialisation 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.

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Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Media Relations

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.