BerGenBio

Regulatory Filings • Apr 2, 2019

BerGenBio: Preclinical data presented at AACR reinforces bemcentinib's potential to reverse tumour immunosuppression and therapy resistance

BerGenBio: Preclinical data presented at AACR reinforces bemcentinib's potential to reverse tumour immunosuppression and therapy resistance

· Extensive data in pre-clinical models of non-small cell lung cancer (NSCLC)

and pancreatic cancer demonstrating AXL's role in reversing tumour-mediated

immunosuppression and therapy resistance presented at AACR

· Selective AXL inhibitor, bemcentinib, shown to reverse AXL's effects, thus

acting synergistically with immune cells and anti-cancer therapies

· Data further strengthens broad development opportunities for bemcentinib

both as a monotherapy, and in combinations, in a broad spectrum of cancers

Bergen, Norway, 2 April 2019 - BerGenBio ASA (OSE: BGBIO) a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, announces preclinical data strengthening

bemcentinib's broad potential in reversing tumour-mediated immunosuppression and

therapy resistance, presented by the Company's academic collaborators at the

American Association for Cancer Research (AACR) Annual Meeting 2019 (March 29 -

April 3, Atlanta, Georgia).

Leading academic groups from the Gustave Roussy Cancer Centre in Paris, France,

MD Anderson Cancer Center in Houston, TX, and UT Southwestern Medical Center in

Dallas, TX, presented three posters describing pre-clinical findings generated

in collaboration with BerGenBio on AXL's role in aggressive cancer and

bemcentinib's therapeutic effect. The data presented lend further support to the

Company's ongoing clinical proof-of-concept programme and planned late stage

strategy evaluating bemcentinib's potential as a monotherapy and in combination

across several indications.

A summary of results presented is given below.

(1) Salem Chouaib et al, Gustave Roussy Cancer Centre, Paris, France: AXL

targeting enhances lymphocyte-mediated cytotoxicity of lung cancer

cells. Abstract - 1200

Summary of results presented:

· NSCLC cells expressing AXL were less prone to cell lysis mediated by

cytotoxic T-lymphocytes (CTL) or NK-cells

· Bemcentinib treatment led to increased CTL and NK-cell mediated killing of

these AXL expressing NSCLC cells

(2) Kavya Ramkumar et al, The University of Texas, MD Anderson Cancer Center,

Houston, TX: Targeting AXL sensitizes non-small cell lung cancer to ATR

inhibitors by enhancing replication stress. Abstract - 276

Summary of results presented:

· Bemcentinib treatment induces DNA damage and a subsequent DNA-damage

response in NSCLC cells in a dose-dependent manner

· Bemcentinib acts synergistically with DNA-damage-repair targeting agents

(ATR inhibitors VX-970 or AZD6738) in reducing viability of NSCLC cells

(3) Wenting Du et al, The University of Texas Southwestern Medical Center,

Dallas, TX: AXL is critical for pancreatic cancer progression and

metastasis. Abstract -1037

Summary of results presented:

· Downregulation of AXL via genetic engineering of pancreatic tumour models

resulted in a more active immune microenvironment, prolonged survival and

improved response to gemcitabine

· Pharmacological intervention with bemcentinib similarly achieves immune

activation and potentiates the effect of gemcitabine in pancreatic models where

AXL is present on tumour and stroma cells

-  END -

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 Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class

selective AXL inhibitor in a broad phase II clinical development programme.

Ongoing clinical trials are investigating bemcentinib in multiple solid and

haematological tumours, in combination with current and emerging therapies

(including immunotherapies, targeted therapies and chemotherapy), and as a

single agent.Bemcentinib targets and binds to the intracellular catalytic kinase

domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in

AXL function has been linked to key mechanisms of drug resistance and immune

escape by tumour cells, leading to aggressive metastatic cancers.

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 AXL antibody (BGB149) and an AXL

-ADC (ADCT-601) are undergoing phase I 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

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic

Communications

bergenbio@consilium-comms.com

+44 20 3709 5700

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.