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BerGenBio

Earnings Release May 18, 2018

3555_rns_2018-05-18_ed79a309-d22d-44f0-97ba-a08e70828d4a.html

Earnings Release

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BerGenBio to present interim clinical and biomarker data with selective AXL inhibitor bemcentinib in AML and MDS at EHA

BerGenBio to present interim clinical and biomarker data with selective AXL inhibitor bemcentinib in AML and MDS at EHA

Bergen, Norway, 18 May 2018 - BerGenBio ASA (OSE:BGBIO) announces that the

company and its collaborators will present interim clinical data from its Phase

II clinical development programme with bemcentinib, a selective, oral AXL

inhibitor, in acute myeloid leukaemia (AML) and myeloid dysplastic syndrome

(MDS) at the 23rd Congress of the European Hematology Association (EHA) in

Stockholm (14-17 June 2018).

Abstracts are now available online at https://ehaweb.org and details of the

presentations are below. The posters presented at EHA will be made available on

www.bergenbio.com in the Investors / Presentations section following the

sessions.

Presentations at EHA

Saturday 16 June, 5:30 - 7:00 PM CEST

Ph II trial with selective oral AXL inhibitor bemcentinib (BGB324) in

relapsed/refractory AML and MDS: Identification of predictive and

pharmacodynamic biomarker candidates associated with pt benefit

· Sonja Loges, MD, PhD et al

· Session: Acute myeloid leukemia - Clinical

· Abstract code: PS981

Single cell signaling pharmacodynamics and clonal evolution in a phase I/II

clinical trial of selective AXL inhibitor bemcentinib (BGB324) in R/R acute

myeloid leukemia and myelodysplastic syndrome

· Monica Hellesøy, PhD et al

· Session: Acute myeloid leukemia - Biology & Translational Research

· Abstract code: PS965

-End-

About BerGenBio ASA

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on

developing a pipeline of first-in-class AXL kinase inhibitors as a potential

cornerstone of combination cancer therapy. 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, bemcentinib (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

during 2018. It is the only selective AXL inhibitor in clinical development.

The Company sponsored clinical trials are:

· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non

-small cell lung cancer (NSCLC)

· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and

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

· Bemcentinib as a single agent and combination therapy in acute myeloid

leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of

the lung and TNBC are conducted in collaboration with Merck & Co., Inc.

(Kenilworth, NJ, USA), through a subsidiary.

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

a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus

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

combining bemcentinib with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify

patient subpopulations most likely to benefit from treatment with bemcentinib.

This will facilitate more efficient registration trials and support a precision

medicine based commercialization 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.

Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

[email protected]

+47 917 86 513

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

[email protected]

+47 995 13 891

International Media Relations

David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson

[email protected]

+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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