BerGenBio

Regulatory Filings • Oct 24, 2017

BerGenBio Announces Start of Ph II Trial Assessing Selective AXL Inhibitor BGB324 in Combination with KEYTRUDA® for Patients with Advanced Lung Cancer

BerGenBio Announces Start of Ph II Trial Assessing Selective AXL Inhibitor BGB324 in Combination with KEYTRUDA® for Patients with Advanced Lung Cancer

Bergen, Norway, 24 Oct 2017 - BerGenBio ASA (OSE:

BGBIO) (http://www.bergenbio.com), a clinical-stage biopharmaceutical company

focused on developing a pipeline of first-in-class Axl kinase inhibitors to

treat multiple cancer indications, announces that the first patient has been

dosed in a Phase II trial evaluating the Company's lead product BGB324 in

combination with KEYTRUDA® (pembrolizumab) in patients with previously treated

advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose

disease is progressing. The trial is being sponsored by BerGenBio. MSD

(tradename of Merck & Co., Inc., Kenilworth, N.J., USA) will supply KEYTRUDA, an

anti-PD-1 therapy, for use in the study under a collaboration agreement signed

between the two companies in March 2017. The trial plans to enrol up to 48

patients at hospitals in Norway, Spain, the UK and the US (ClinicalTrials.gov

Identifier: NCT03184571).

The clinical study will primarily evaluate the anti-tumour activity, objective

response rate, and safety profile of the combination. Additionally, the study

will assess the pharmacokinetic profile of BGB324 when given with KEYTRUDA.

Comprehensive exploratory studies will evaluate biomarkers in tumour and blood

indicative of immune modulation and Axl signalling, including expression levels

of PD-L1 and Axl. The trial is expected to deliver preliminary results around

the end of 2018.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "This is the

second trial under our collaboration agreement with MSD to evaluate the

combination of our selective Axl inhibitor BGB324 with MSD's approved anti-PD-1

therapy, KEYTRUDA. With this study in advanced NSCLC and our other

BGB324/KEYTRUDA study in advanced breast cancer, we hope to generate compelling

clinical evidence that blocking Axl signalling can reverse and prevent tumour

resistance to anti-PD-1 therapies and lead to improved clinical outcomes. The

results from these studies and those from our broader Phase II programme with

BGB324, which we expect to read-out in 2018, will be crucial to establishing its

potential as a key factor in the treatment of many aggressive cancers."

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 deaths. 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 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), through a

subsidiary.

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.

-Ends-

Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Tom Henrik Sundby

Finance Director, BerGenBio ASA

+47 477 54 415

tom.sundby@bergenbio.com

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.