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.

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