Bergen, Norway, 14 Nov 2017 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, is pleased to announce that the Company will present its recently initiated Phase II clinical trial investigating BGB324 in combination with the Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with triple negative breast cancer (TNBC) at the 2017 San Antonio Breast Cancer Symposium in San Antonio, USA (5-9 Dec 2017).
The poster presentation will describe the rationale and design of the combination study with KEYTRUDA and BGB324, a first-in-class and highly selective small molecule Axl kinase inhibitor, which is being developed to target tumour immune evasion and resistance.
The poster will be presented by Murray Yule (MD, PhD) Clinical Development Officer at BerGenBio, and is entitled: A Phase II multi-center study of BGB324 in combination with pembrolizumab in patients with previously treated, locally advanced and unresectable or metastatic triple negative breast cancer (TNBC) or triple negative inflammatory breast cancer (TN-IBC)
- Abstract ID#: 851840 – Henry B. Gonzalez Convention Center, San Antonio, USA, 9-12 Dec 2017
- Session: Ongoing Trials – Immunotherapy, OT1 – Wednesday, 6 Dec 2017, 5pm-7pm
- ClinicalTrials.gov identifier: NCT03184558
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.
CEO, BerGenBio ASA
+47 917 86 304
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.