Clinical Study with BGB324, BerGenBio’s Selective First-in-Class AXL Inhibitor, to be Presented at the 9th World Congress of Melanoma

Bergen, Norway, Oct 12 2017 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces that the clinical trial of BGB324 in combination with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA® in advanced melanoma, will be presented at the 9th World Congress of Melanoma in Brisbane, Australia, October 18-21, 2017.

Dr. Oddbjørn Straume, consultant oncologist at Haukeland University Hospital and Professor at the University of Bergen Centre for Cancer Biomarkers will present a poster entitled: A Phase Ib/II randomised study of BGB324 in combination with pembrolizumab or dabrafenib/trametinib in patients with advanced melanoma. The presentation will introduce the trial design and study background as well as present safety data of metastatic melanoma patients treated to date.

  • Poster number P12-10 – Brisbane Convention & Exhibition Centre, October 18 – 21 2017

For more information visit: https://www.melanomacongress.com/

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 solid and haematological 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:

  1. BGB324 as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
  2. BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
  3. BGB324 with KEYTRUDA® (pembrolizumab) in advanced adenocarcinoma of the lung, and
  4. 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). 

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

Tom Henrik Sundby

Finance Director, BerGenBio ASA

+47 477 54 415

tom.sundby@bergenbio.com

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.

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About Us

BerGenBio is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class selective AXL kinase inhibitors to treat multiple aggressive cancers. The Company is a world leader in understanding the central role of AXL kinase in promoting cancer spread, immune evasion and drug resistance – the cause of approximately 90 percent of cancer deaths. Inhibition of AXL kinase activity represents a novel approach to addressing a key mechanism in the evolution of cancer cell malignancy and aggressiveness, offering an opportunity to create important new therapeutic options for cancer patients.

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