BerGenBio

Regulatory Filings • Jan 9, 2019

BerGenBio Announces Start of Phase I Trial Evaluating First-in-Class Anti-AXL Antibody BGB149

BerGenBio Announces Start of Phase I Trial Evaluating First-in-Class Anti-AXL Antibody BGB149

· BGB149 is the first therapeutic anti-AXL monoclonal antibody to enter

clinical development

· BGB149 is BerGenBio's second novel clinical candidate targeting AXL

· Phase I study will investigate safety and pharmacokinetics in healthy

volunteers

Bergen, Norway, January 9 2019 - BerGenBio ASA (OSE:BGBIO),a clinical-stage

biopharmaceutical company focused on developing a pipeline of first-in-class

drug candidates targeting AXL kinase to treat aggressive diseases including

immune-evasive and therapy resistant cancers, announces today that the

first subject has been dosed in a Phase I clinical trial evaluating the anti-AXL

therapeutic monoclonal antibody BGB149 in healthy volunteers.

BGB149 is the first functional blocking anti-AXL monoclonal antibody to enter

clinical development and is BerGenBio's second clinical stage drug development

programme targeting AXL.

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

delighted to initiate this Phase I study as planned. BGB149 has cleared all

required regulatory pre-clinical evaluations. This AXL functional blocking

antibody is BerGenBio's second drug candidate to enter clinical trials: An

important milestone in expanding our pipeline of first-in-class AXL targeting

drug candidates positioned to treat aggressive diseases with severe unmet

medical need. We are expecting results from this Phase I trial in 2019 and are

looking forward to announcing BGB149's further clinical development strategy in

the coming months."

- END -

About BGB149 and the Phase I Healthy Volunteer Trial

BGB149 is a fully humanised anti-AXL functional blocking monoclonal antibody,

developed and fully-owned by BerGenBio. A robust, high yielding manufacturing

process has been established and preclinical studies have confirmed its

mechanism of action as well as efficacy.

The Phase I healthy volunteer trial BGB149-101 will enrol up to 36 subjects

andinvestigate the safety, tolerability and pharmacokinetics of BGB149 following

single dose administration.The study is being sponsored by BerGenBio.

For more information, see ClinicalTrials.gov: NCT03795142

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the

biological mechanisms underlying life-threatening diseases. In cancer, AXL

suppresses the body's immune response to tumours and drives cancer treatment

failure across many indications. AXL inhibitors, therefore, have potential high

value at the centre of cancer combination therapy, addressing significant unmet

medical needs and multiple high-value market opportunities. Research has also

shown that Axl mediates other aggressive diseases.

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing

transformative drugs targeting AXL as a potential cornerstone of therapy for

aggressive diseases, including immune-evasive, therapy resistant cancers. The

company's proprietary lead candidate, bemcentinib, is a potentially first-in

-class selective AXL inhibitor in a broad phase II oncology clinical

development programme focussed on combination and single agent therapy in lung

cancer and leukaemia. A first-in-class functional blocking anti-AXL antibody is

undergoing Phase 1 clinical testing. In parallel, BerGenBio is developing a

companion diagnostic test to identify those patient populations most likely to

benefit from bemcentinib: this is expected to facilitate more efficient

registration trials supporting a precision medicine-based commercialisation

strategy.

BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The

company is listed on the Oslo Stock Exchange (ticker: BGBIO). www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

+47 917 86 513

International Media Relations

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

bergenbio@citigatedewerogerson.com

+44 207 638 9571

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+47 995 13 891

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.