BerGenBio

Regulatory Filings • Apr 18, 2018

BerGenBio: Promising data highlighting selective AXL inhibitor bemcentinib's potential to improve efficacy of checkpoint inhibitors presented at AACR

BerGenBio: Promising data highlighting selective AXL inhibitor bemcentinib's potential to improve efficacy of checkpoint inhibitors presented at AACR

Bergen, Norway, 18 April 2018 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, announces that promising preclinical data with its

lead AXL inhibitor bemcentinib (formerly BGB324) has been presented in a poster

at the 2018 American Association for Cancer Research (AACR) Annual Meeting on 14

-18 April in Chicago, IL, USA.

The data highlight bemcentinib's potential to reverse tumour immune suppression

and enhance immune checkpoint inhibitor efficacy.

The authors show that bemcentinib targets immune suppression mechanisms in the

tumour microenvironment that improve immunotherapy in murine tumour models of

non-small cell lung (NSCLC), triple negative breast (TNBC) and pancreatic

cancer. Bemcentinib treatment reduces myeloid-derived suppressor cells and the

altered immune landscape is associated with increased tumour infiltration of T

cells (NK and CD8+) and enhanced therapy responses.

A validated AXL immunohistochemistry (IHC) method for use on patient samples to

identify the presence of AXL on tumour cells and immune cells in the tumour

microenvironment was presented. The authors report that across 92 banked tumour

biopsies from patients with TNBC or NSCLC 70% were found to stain positive for

AXL using this IHC method. The IHC method is now in use to analyse biopsies

taken in connection with the company's phase II combination trials of

bemcentinib with KEYTRUDA® in patients with advanced NSCLC or TNBC.

Professor James Lorens, BerGenBio Chief Scientific Officer, commented: "These

results highlight a clear and important role for AXL in aggressive disease and

resistance to immune therapy in particular. They provide continued confidence in

the potential of combining bemcentinib with immune checkpoint inhibitors to

improve cancer treatment, and support for our Phase II clinical trial programme

of bemcentinib combined with the blockbuster immune checkpoint inhibitor

KEYTRUDA, interim results from which are expected during 2018."

The poster is available online - www.bergenbio.com/investors/presentations/

-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

rune.skeie@bergenbio.com

+47 917 86 513

Media Relations in Norway

Jan Petter Stiff, Crux Advisors

stiff@crux.no

+47 995 13 891

International Media Relations

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

bergenbio@citigatedewerogerson.com

+44 207 638 9571

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.