BerGenBio

Regulatory Filings • Sep 5, 2018

BerGenBio to present interim phase 2 clinical data with selective AXL inhibitor bemcentinib in non-small cell lung cancer at WCLC

BerGenBio to present interim phase 2 clinical data with selective AXL inhibitor bemcentinib in non-small cell lung cancer at WCLC

Bergen, Norway, 5 September 2018 - BerGenBio ASA (OSE:BGBIO) announces that the

company and its collaborators will present interim clinical data from its Phase

II clinical development programme with bemcentinib (BGB324), a first-in-class

highly selective oral AXL inhibitor, in non-small cell lung cancer (NSCLC) at

the 19th World Conference on Lung Cancer (WCLC) in Toronto (23 - 26 September

2018).

Full abstracts are available online at https://wclc2018.iaslc.org from 5 PM

(Eastern Time) on 5 September 2018 and details of the presentations are below.

The posters presented at WCLC will be made available at www.bergenbio.com in the

Investors / Presentations section following the sessions.

Poster presentations at WCLC:

Tuesday 25 September, 4:45 - 6:00 PM (Eastern Time)

Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination

with Pembrolizumab in Patients with Advanced NSCLC (BerGenBio study reference:

BGBC008)

· James Lorens, PhD et al

· Session: P2.04 - Immunooncology

· Abstract code: P2.04-27

Ph I/II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in

Combination with Erlotinib in pts with EGFRm NSCLC (BerGenBio study reference:

BGBC004)

· Lauren Averett Byers, MD et al

· Session: P2.13 - Targeted Therapy

· Abstract code: P2.13-10

A Ph I/II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) with

Docetaxel in pts with Previously Treated NSCLC (BerGenBio study reference:

BGBIL005)

· David Gerber, MD et al

· Session: P2.01 - Advanced NSCLC

· Abstract code: P2.01-37

A Phase II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in

Combination with Pembrolizumab in pts with Malignant Mesothelioma (trial not

active yet)

· Dean Fennell, PhD et al

· Session: P2.06 - Mesothelioma

· Abstract code: P2.06-09 - MiST3

About WCLC

19th World Conference on Lung Cancer (WCLC 2018) is the leading meeting on

Thoracic Oncology. It is organised by the International Association for the

Study of Lung Cancer and will gather more than 7,000 international delegates.

WCLC 2018 will take place in the Metro Toronto Convention Centre in Toronto,

Ontario Canada, 23 - 26 September 2018.

About the BGBC008 trial

The BGBC008 trial is a Phase II multi-centre open-label study of bemcentinib in

combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy

naïve, patients with advanced adenocarcinoma of the lung, the most common form

of non-small cell lung cancer (NSCLC). The objective of the trial is to

determine the anti-tumour activity of this novel drug combination and responses

will be correlated with biomarker status (including AXL kinase and PD-L1

expression).

As of September 2018, the first stage of the trial has been fully recruited, and

the first efficacy endpoint was met. Responders to the combination treatment

included patients negative for PD-L1 for whom KEYTRUDA monotherapy is not

effective.

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

About the BGBC004 trial

The BGBC004 trial is a phase I/II multi-centre open-label study

of bemcentinib in combination with TARCEVA (erlotinib) in patients with EGFR

mutation driven (EGFRm) 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 resistance mutation (arm B) as well as prevention

of resistance to TARCEVA in patients receiving the EGFR inhibitor first line

(arm C).

The first efficacy endpoint was met in Arm B and encouraging preliminary data

has been presented for Arm C. The dose-finding part of the trial, arm A, is

completed and was presented at WCLC 2017.

For more information please access trial NCT02424617 at www.clinicaltrials.gov.

About the BGBIL005 trial

The BGBIL005 trial is an investigator-led phase I/II study of bemcentinib in

combination with docetaxel chemotherapy in previously treated, relapsed /

resistant NSCLC patients. Patient recruitment into the study is progressing and

encouraging clinical responses have been reported following the combination

treatment.

For more information please access trial NCT02922777 at www.clinicaltrials.gov.

About the MiST3 trial

The MiST3 trial is an investigator-led phase II study of bemcentinib in

combination with KEYTRUDA in patients with relapsed mesothelioma. The trial,

which is not active as of September 2018, is sponsored by the University of

Leicester (Leicester, UK), and funded by the British Lung Foundation with

support from Merck Sharp and Dohme Limited and BerGenBio. Up to 25 patients are

planned to be enrolled at 3 clinical research sites in the UK.

For more information please access trial NCT03654833 at www.clinicaltrials.gov

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About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing

transformative drugs targeting AXL as a potential cornerstone of therapy for

advanced and aggressive cancers.

The company's proprietary lead candidate, bemcentinib, 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.

In parallel, BerGenBio is developing a companion diagnostics test to identify

patient populations most likely to benefit from bemcentinib; this is expected to

facilitate more efficient registration trials and support 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

About AXL

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

biological mechanisms that drive aggressive and life-threatening diseases. In

cancer, AXL drives tumour survival, treatment resistance and spread, as well as

suppressing the body's immune response to tumours. AXL expression has been

established as a negative prognostic factor in many cancers. AXL inhibitors,

therefore, have potential value at the centre of cancer combination therapy,

addressing significant unmet medical needs and multiple high-value market

opportunities.

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.