BerGenBio

Regulatory Filings • Feb 19, 2018

BerGenBio completes recruitment into first stage of Phase II breast cancer trial with selective AXL inhibitor bemcentinib combined with KEYTRUDA®

BerGenBio completes recruitment into first stage of Phase II breast cancer trial with selective AXL inhibitor bemcentinib combined with KEYTRUDA®

Bergen, Norway, 19 February 2018 - BerGenBio ASA (http://www.bergenbio.com)

(OSE: BGBIO) announces that it has completed enrolment, ahead of schedule, of

the planned 28 patients into the first stage of its Phase II clinical trial

evaluating its investigational oral selective AXL inhibitor bemcentinib (BGB324)

in combination with the Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD

outside the United States and Canada) anti-PD-1 therapy KEYTRUDA®

(pembrolizumab) as a potential new treatment regimen for advanced breast cancer.

The Phase II trial (BGBC007) follows a two-stage design: it is an open label,

multi-centre study of bemcentinib in combination with KEYTRUDA in patients with

previously treated, locally advanced and unresectable or metastatic triple

negative breast cancer (TNBC) or triple negative inflammatory breast cancer (TN

-IBC). Up to 56 patients in total will be included in the study (NCT03184558).

The trial is designed to evaluate efficacy and safety of the combination, and to

correlate the patient response with biomarker status (AXL kinase and PD-L1

expression). In parallel, companion diagnostics using these biomarkers, and

others, are being developed for the identification of patients predicted to be

most suitable for treatment with the bemcentinib / KEYTRUDA combination. Interim

results are expected mid-year 2018.

The trial, which began in October 2017, is being conducted under a clinical

collaboration with Merck & Co., Inc., Kenilworth, N.J., USA, through a

subsidiary, and is taking place at more than 16 clinical sites in the US and

Europe.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are

delighted to have completed patient enrolment into the first part of this Phase

II trial in such a short time and ahead of schedule. Immuno-oncology therapies,

such as KEYTRUDA, are now established as a major treatment option for cancer

patients and we are excited with the progress being seen across our clinical

trials exploring if bemcentinib in combination with KEYTRUDA can result in

significantly improved patient outcomes. Positive results from these trials, and

from our broader Phase II development programme will help confirm the great

potential we see for bemcentinib as a cornerstone therapy across multiple cancer

indications and in combination with existing and emerging modalities of cancer

treatment. We look forward to interim results from this and other studies during

2018."

Preliminary safety data, reported at the ASCO-SITC Clinical Immuno-Oncology

Symposium (January 2018), found that the bemcentinib / KEYTRUDA combination was

well tolerated in a sample of patients across three cancer indications in which

it is being studied (advanced breast cancer, lung cancer and melanoma) with a

safety profile similar to KEYTRUDA alone. Nineteen of the 34 patients evaluated

in this analysis were from the BGBC007 breast cancer trial.

-End-

About TNBC

Breast cancer is the most common cancer in women - it is estimated that more

than 250,000 new cases will be diagnosed in the US in 2018. 20% of breast

cancers lack receptors for three common hormones (oestrogen, progesterone and

HER2) and are thus called triple-negative breast cancers (TNBC). Treatment

options for TNBC are limited to intense chemotherapy, but disease recurrence is

frequent and aggressive. Consequently, novel treatment strategies for TNBC are

urgently needed.

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

Tom Henrik Sundby

Finance Director, BerGenBio ASA

tom.sundby@bergenbio.com

+47 477 54 415

Media Relations

David Dible, Mark Swallow, Marine Perrier

Citigate Dewe Rogerson

bergenbio@citigatedewerogerson.com

+44 207 638 9571

Forward looking statements

This announcement may contain forward-looking statements, which as such are not

historical facts, but are based upon various assumptions, many of which are

based, in turn, upon further assumptions. These assumptions are inherently

subject to significant known and unknown risks, uncertainties and other

important factors. Such risks, uncertainties, contingencies and other important

factors could cause actual events to differ materially from the expectations

expressed or implied in this announcement by such forward-looking statements

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

-12 of the Norwegian Securities Trading Act.