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BerGenBio

Regulatory Filings Jul 26, 2017

3555_rns_2017-07-26_734f2600-b5e4-4cfb-8148-f29bc898757a.html

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BerGenBio to Present its First-In-Class, Selective AXL Inhibitor BGB324 at Precision: Lung Cancer - World R&D Summit in Boston

BerGenBio to Present its First-In-Class, Selective AXL Inhibitor BGB324 at Precision: Lung Cancer - World R&D Summit in Boston

Bergen, Norway, July 26 2017 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company focussed on developing novel, selective AXL kinase

inhibitors for multiple cancer indications, is pleased to announce that Murray

Yule, MD, PhD, Clinical Development Officer at BerGenBio, will present an

outline of the phase II clinical development programme of BerGenBio's lead

product, BGB324, in non-small cell lung cancer (NSCLC) at the Precision: Lung

Cancer conference in Boston, July 25-26, 2017.

The presentation will take place on Wednesday 26, 3pm EST and will cover recent

evidence of the benefits of selective AXL inhibition in order to overcome

therapy resistance and immune escape as well as boost anti-tumour immunity. Dr

Yule will discuss in detail the scientific and clinical rationale underpinning

BerGenBio's phase II clinical trial portfolio with BGB324 in NSCLC in

combination with chemo-, targeted and immunotherapy. The aim of these clinical

studies is to deliver proof-of-concept of BGB324's potential to counteract AXL

driven immune evasion and acquired resistance to therapy thereby uniquely

synergising with and enhancing current and emerging therapies.

About NSCLC

It is estimated that more than 220,000 new cases of lung cancer will be

diagnosed in the US in 2017 and it is the leading cause of cancer death. 65% of

NSCLCs are of adenocarcinoma pathology. Although various treatments exist for

NSCLC, they are often curtailed by acquired resistance to therapy and immune

evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently

required.

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 six Phase II clinical trials in major

cancer indications with read-outs expected in the second half of 2018. It is the

only selective AXL inhibitor in clinical development.

The clinical trials are:

· BGB324 as a single agent 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 NSCLC (adenocarcinoma of

the lung), and

· BGB324 with KEYTRUDA® 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).

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

to investigate BGB324 with either MEKINIST® (trametinib) and TAFINLAR®

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

TAXOTERE® (docetaxel) in advanced non-small-cell lung cancer (NSCLC).

BerGenBio is simultaneously developing a companion diagnostic test that will be

able to identify patient subpopulations most likely to benefit from the

treatment. This will facilitate more efficient registration trials and support a

precision medicine approach in reimbursement and 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. TARCEVA® is a registered trademark of OSI Pharmaceuticals,

LLC., marketed by Roche-Genentech.

-Ends-

Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

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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