BerGenBio to Present Interim Clinical and Biomarker Data From Phase II Development Programme With Selective AXL Inhibitor Bemcentinib at ASCO

• Four peer reviewed BerGenBio abstracts on clinical data with bemcentinib accepted for presentation at ASCO
• BerGenBio to host KOL reception to showcase bemcentinib studies and potential as a cornerstone of cancer therapy

BERGEN, Norway, 16, May 2018 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO) announces that the company and its collaborators will present new interim clinical and biomarker data from its extensive Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO) at McCormick Place in Chicago, IL (1-5 June 2018). Abstracts are now available online at https://am.asco.org/ and details of the presentations are below. The posters presented at ASCO will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.

Presentations at ASCO

Monday 4 June, 8:00 AM - 11:30 AM Central Daylight Time (Hall A)

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC.

• James Lorens, PhD et al
• Session: Developmental Therapeutics – Immunotherapy
• Poster Board: #292, Abstract 3078

Identification of predictive and pharmacodynamic biomarkers associated with the first-in-class selective AXL inhibitor bemcentinib across multiple Phase II clinical trials.

• Robert J Holt, PhD et al
• Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
• Poster Board: #385, Abstract 2559

Analysis of anti-leukemic activity, predictive biomarker candidates, immune activation and pharmakodynamics in R/R AML and MDS in response to treatment with bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a Phase II open-label, multi-centre study.

• Bjørn T. Gjertsen, MD, PhD et al
• Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
• Poster Board: #80, Abstract 7020
• To be discussed at the Poster Discussion Session on Monday 4 June, 11:30 AM - 12:45 PM, at E450

Monday 4 June, 1:15 PM - 4:45 PM CDT (Hall A)

A randomized Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma.

• Oddbjørn Straume, MD, PhD et al
• Session: Melanoma/Skin Cancers
• Poster Board: #375, Abstract 9548

BerGenBio reception

Coinciding with ASCO, BerGenBio will host a reception for collaborators, investors, analysts, media and other interested parties on 2 June at The School of the Art Institute Ballroom in Chicago. At this event, short presentations will be given by clinical investigators participating in the bemcentinib clinical trials and by KOL experts in AXL kinase function. For further details and to receive an invitation, please click here or email: [email protected].

The presentations will be made available on BerGenBio's website in the Investors / Presentations section following the event.

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 aggressive disease, including immune evasive, drug resistant, metastatic 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 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.

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.

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Contacts

Richard Godfrey
CEO, BerGenBio ASA
+47-917-86-304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47-917-86-513

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+47-995-13-891

International Media Relations

David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
[email protected]
+44-207-638-9571

SOURCE BerGenBio ASA