BerGenBio

Regulatory Filings • Sep 28, 2017

BGB324, BerGenBio's Selective First-in-Class AXL Inhibitor, Featured in Three Clinical Presentations at the 18th World Conference on Lung Cancer

BGB324, BerGenBio's Selective First-in-Class AXL Inhibitor, Featured in Three Clinical Presentations at the 18th World Conference on Lung Cancer

Bergen, Norway, Sep 28 2017 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective Axl kinase

inhibitors (http://www.bergenbio.com) for multiple cancer indications, is

pleased to announce that the Company will present three ongoing lung cancer

clinical trials with BGB324 at the 18th World Conference on Lung Cancer in

Yokohama, Japan, October 15 - 18, 2017.

The three presentations will show clinical results to date and discuss the

rationale of the clinical studies undertaken with BGB324, BerGenBio's lead

candidate, a first-in-class and highly selective small molecule Axl kinase

inhibitor which is being developed to target tumour immune evasion and drug

resistance.

Don L. Gibbons (MD, PhD) from the MD Anderson Cancer Center, Houston (US) will

give an oral presentation entitled: A Ph I/II Study of BGB324, a Selective AXL

Inhibitor as Monotherapy and in Combination with Erlotinib in Advanced NSCLC.

The presentation will focus on the tolerability and efficacy combining BGB324

and erlotinib (TARCEVA®) in patients with advanced NSCLC driven by an EGFR

mutation.

· Abstract 10388 - Monday, October 16, 2017, Oral and Mini Oral Abstract

Sessions: 11:00-12:30 (JST)

· ClinicalTrials.gov identifier: NCT02424617

Murray Yule (MD, PhD), Clinical Development Officer at BerGenBio, will present a

poster entitled: A Phase II Study of BGB324 in Combination with Pembrolizumab in

Patients with Previously Treated Advanced Lung Adenocarcinoma. The trial-in

-progress poster introduces the scientific rationale of combining BGB324 with

pembrolizumab (KEYTRUDA®) in non-small cell lung cancer patients.

· Abstract 10315 - Tuesday, October 17, 2017, P2.07 Poster Session: 9:30 -

16:00 (JST)

· ClinicalTrials.gov identifier: NCT03184571

David E. Gerber (MD, PhD) from the Harold C. Simmons Comprehensive Cancer

Center, University of Texas Southwestern Medical Center (US) will present a

poster entitled:  A Phase 1 trial of dose escalated BGB324 in combination with

docetaxel for previously treated advanced NSCLC. The trial-in-progress poster

introduces the scientific rationale of combining BGB324 with chemotherapeutic

agents and will present available clinical data from the ongoing investigator

initiated trial combining BGB324 with docetaxel.

· Abstract 10230 - Tuesday, October 17, 2017, P2.07 Poster Session: 9:00 -

16:00 (JST)

· ClinicalTrials.gov identifier: NCT02424617

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

pleased to have the opportunity to share our results and research at the 18th

World Conference on Lung Cancer this year. The studies highlight our broad

clinical development strategy, which is designed to demonstrate the potential of

BGB324, a highly selective Axl inhibitor, to significantly improve the treatment

of lung cancer.

About the 18th World Conference on Lung Cancer

The World Conference on Lung Cancer (WCLC) is the world's largest meeting

dedicated to lung cancer and other thoracic malignancies, attracting over 6,000

researchers, physicians and specialists from more than 100 countries. The goal

is to disseminate the latest scientific achievements; increase awareness,

collaboration and understanding of lung cancer; and to help participants

implement the latest developments across the globe. Organized under the theme of

"Synergy to Conquer Lung Cancer," the conference will cover a wide range of

disciplines and unveil several research studies and clinical trial results. For

more information, visit http://wclc2017.iaslc.org/.

About BerGenBio ASA

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on

developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple

cancer indications. 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 haematological and solid cancers.

BerGenBio's lead product, 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 in the

second half of 2018. It is the only selective Axl inhibitor in clinical

development.

The Company sponsored clinical trials are:

· BGB324 as a single agent and combination therapy in acute myeloid leukaemia

(AML) / myeloid dysplastic syndrome (MDS)

· BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small

cell lung cancer (NSCLC)

· BGB324 with KEYTRUDA® (pembrolizumab) in advanced adenocarcinoma of the

lung, and

· BGB324 with KEYTRUDA® in triple negative breast cancer (TNBC).

The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung

and TNBC are conducted in collaboration with Merck & Co. Inc. (MSD), through a

subsidiary.

In addition, a number of investigator-sponsored trials are underway, including a

trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR®

(dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining

BGB324 with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify

patient subpopulations most likely to benefit from treatment with BGB324. This

will facilitate more efficient registration trials and support a precision

medicine based commercialisation 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.

-Ends-

Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Media Relations

David Dible, Mark Swallow, Marine Perrier

Citigate Dewe Rogerson

bergenbio@citigatedr.co.uk

+44 207 638 9571

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

-12 of the Norwegian Securities Trading Act.