BerGenBio

Regulatory Filings • Nov 6, 2019

BERGENBIO'S BEMCENTINIB MEETS PRIMARY ENDPOINT IN FIRST COHORT OF PHASE 2 NSCLC STUDY IN COMBINATION WITH KEYTRUDA®

BERGENBIO'S BEMCENTINIB MEETS PRIMARY ENDPOINT IN FIRST COHORT OF PHASE 2 NSCLC STUDY IN COMBINATION WITH KEYTRUDA®

·  Primary endpoint, Overall Response Rate, has been met in predominantly PD-L1

negative/low patients

·  Secondary endpoint, median Progression Free Survival, exceeds expectations

in AXL positive patients

·  Data to be presented at Society for Immunotherapy of Cancer 34th Annual

Meeting on 8 November 2019

Bergen, Norway, 6 November 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, announces today that the primary endpoint of

Overall Response Rate (ORR) has been met in Cohort A of its Phase II clinical

trial (BGBC008) evaluating bemcentinib, its first in class selective AXL

inhibitor, in combination with the MSD's, (a tradename of Merck & Co., Inc.,

Kenilworth, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab), as a

potential new treatment regimen for previously treated advanced non-small cell

lung cancer (NSCLC). The primary efficacy endpoint requires that at least 25%

evaluable patients achieve a clinical response when treated with the novel drug

combination, defined as either complete or partial response, as measured by

Response Evaluation Criteria in Solid Tumors (RECIST).

A secondary endpoint of median Progression Free Survival (mPFS) reported

significant 3-fold improvement in AXL positive vs negative patients, as defined

by BerGenBio's composite AXL tumor-immune score.

These data will be presented during at the Society for Immunotherapy of Cancer

in the High Impact Clinical Trials session on Friday 8 November in a

presentation entitled: A phase II study of bemcentinib (BGB324), a first-in

-class selective AXL inhibitor, in combination with pembrolizumab in patients

with advanced NSCLC: Updated analysis.

Professor Hani Gabra MD PhD, Chief Medical Officer of BerGenBio, commented: "I

am impressed by these results that clearly demonstrate the durable clinical

benefits in this difficult to treat low PD-L1 patient population. Importantly

the patients that benefit most match gene signatures that predict poor prognosis

and a lack of response to immunotherapy in NSCLC".

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "I am

delighted to see continued significant patient benefit from bemcentinib in

combination with Keytruda. This is the first of three cohorts where we are

evaluating this combination in previously treated lung cancer patients and I

look forward to reporting data from these additional cohorts in the coming

months."

Presentation details

A phase II study of bemcentinib (BGB324), a first-in-class selective AXL

inhibitor, in combination with pembrolizumab in patients with advanced NSCLC:

Updated analysis

·  Matthew G. Krebs, MD, PhD -The University of Manchester

·  Concurrent Session 206: High Impact Clinical Trials

·  Oral Session

·  08 November 2019: Prince George's Exhibition Hall C, 4:50 - 6:15 p.m. EST

- 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. Tumour AXL expression is associated with poor

prognosis in NSCLC and most other cancer types. 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 focused 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.