BerGenBio

Regulatory Filings • Mar 15, 2018

BerGenBio - US Clinical Trial Update

BerGenBio - US Clinical Trial Update

Bergen, Norway, 15 March 2018 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective Axl kinase inhibitors for

multiple cancer indications, provides an update on BGBC004, an ongoing, company

sponsored USA only phase Ib/II clinical trial evaluating bemcentinib in

combination with TARCEVA® (erlotinib) in first and second line patients with non

-small cell lung cancer (NSCLC).

In November 2017, BerGenBio informed that the Company was in voluntary

discussions with the Regional Ethics Committee (REK) in Bergen and the Norwegian

Board of Health about gaining retrospective approval for the study; the Company

can confirm that it has now received a notice of non-acceptance from the

Norwegian National Ethics Committee (NEM) for the retrospective approval for the

conduct of this clinical trial outside Norway.

In accordance with international good clinical practice BerGenBio secured all

necessary approvals from the US Food & Drug Administration (FDA) and from the

ethics committees at the participating USA hospitals prior to initiating the

study in 2014.

To date 33 NSCLC patients have been enrolled in the trial and ten patients have

reported clinical benefit (four partial responses and six stable disease) from

taking the combination of bemcentinib and erlotinib. In some cases, the patient

benefit is observed for more than two years. This preliminary outcome is viewed

as very promising at this stage in the clinical development of bemcentinib.

The clinical trial remains ongoing in the USA, BerGenBio maintains the view that

the study qualifies for retrospective approval and will formally ask NEM to

reconsider their decision. There is currently uncertainty what implications the

decision may have for the study (if the decision is upheld), as no research

activities are carried out in Norway and all necessary foreign approvals have

been acquired. BerGenBio will attempt to secure a meeting with the authorities

to determine the future next steps.

BerGenBio has relevant approvals for all of the other Phase II clinical trials

with bemcentinib that are currently ongoing in multiple cancer indications,

alone and in combination with other cancer therapies.

Richard Godfrey, BerGenBio CEO: commented: "We are disappointed and perplexed

that NEM has not provided us with a clear explanation for its decision not to

provide retrospective approval for the bemcentinib-erlotinib combination study.

This trial has all the necessary approvals in the USA where it is being

conducted and is generating promising clinical results in patients with advanced

lung cancer. We are strongly committed to working towards a solution with the

relevant authorities in Norway, and in the meantime the clinical trial remains

ongoing in the USA, with an interim readout expected in mid-2018."

- Ends -

About the BGBC004 trial

The BGBC004 trial is a Phase I/II multi-centre open-label study of bemcentinib

in combination with erlotinib in patients with EGFR mutation driven Stage IIIb

or Stage IV NSCLC. The trial is designed to evaluate reversal of resistance to

EGFR targeted therapy in later line patients who are negative for the T790M

mutation as well as prevention of resistance in patients receiving the EGFR

inhibitor erlotinib first line. Patients are currently being enrolled at centres

across in the US. For more information please access trial NCT02424617

at www.clinicaltrials.gov.

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.

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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.

Contact

Richard Godfrey, CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

+47 917 86 513

Media Relations

Jan Petter Stiff, Crux Advisors

stiff@crux.no

+47 995 13 891

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.