BerGenBio to Present Interim Clinical and Biomarker Data With Selective AXL Inhibitor Bemcentinib in AML and MDS at EHA

BERGEN, Norway, May 18, 2018 /PRNewswire/ --

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, a selective, oral AXL inhibitor, in acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS) at the 23rd Congress of the European Hematology Association (EHA) in Stockholm (14-17 June 2018).

Abstracts are now available online at https://ehaweb.org and details of the presentations are below. The posters presented at EHA will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.

Presentations at EHA

Saturday 16 June, 5:30 - 7:00 PM CEST

Ph II trial with selective oral AXL inhibitor bemcentinib (BGB324) in relapsed/refractory AML and MDS: Identification of predictive and pharmacodynamic biomarker candidates associated with pt benefit

• Sonja Loges, MD, PhD et al
• Session: Acute myeloid leukemia - Clinical
• Abstract code: PS981

Single cell signaling pharmacodynamics and clonal evolution in a phase I/II clinical trial of selective AXL inhibitor bemcentinib (BGB324) in R/R acute myeloid leukemia and myelodysplastic syndrome

• Monica Hellesøy, PhD et al
• Session: Acute myeloid leukemia - Biology & Translational Research
• Abstract code: PS965

About BerGenBio ASA

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy. 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 solid and haematological cancers.
BerGenBio's lead product, bemcentinib (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 during 2018. It is the only selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:

• Bemcentinib with TARCEVA (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
• Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
• Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
• Bemcentinib as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth, NJ, USA), through a subsidiary.

In addition, a number of investigator-sponsored trials are underway, including a trial to investigate bemcentinib with either MEKINIST (trametinib) plus TAFINLAR (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining bemcentinib with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib. This will facilitate more efficient registration trials and support a precision medicine based commercialization 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.

Contacts

Richard Godfrey
CEO, BerGenBio ASA
[phone]

Rune Skeie, CFO, BerGenBio ASA
[e-mail]
[phone]

Media Relations in Norway
Jan Petter Stiff, Crux Advisers
[e-mail]
[phone]

International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
[e-mail]
[phone]

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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