BerGenBio enters collaboration with MSD focused on clinical evaluation of BGB324 in combination with KEYTRUDA® (pembrolizumab) in advanced lung and breast cancer

08.03.2017

Bergen, Norway, 8 March 2017: BerGenBio ASA, a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces it has entered into a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada) , through a subsidiary, focused on the clinical evaluation of BGB324 with KEYTRUDA® (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

BerGenBio’s lead candidate BGB324 is a first in class, highly selective, potent and orally available small molecule Axl kinase inhibitor in clinical development in a variety of cancer indications. The Axl tyrosine kinase is a key driver of cancer spread, immune evasion and drug resistance – the cause of the majority of cancer-related deaths. Increased understanding of the role of Axl in suppressing innate immunity supports the rationale for evaluating BGB324 in combination with KEYTRUDA.

Under the terms of the collaboration with MSD, BerGenBio will conduct two international Phase II studies to evaluate the potential clinical synergy of combining BGB324 with MSD’s anti-PD-1 therapy, KEYTRUDA. Details of the studies are as follows:

BGBC007 – A Phase II multi-centre study of BGB324 in combination with KEYTRUDA in patients with previously treated, locally advanced or unresectable TNBC.

BGBC008 – A Phase II multi-centre study of BGB324 in combination with KEYTRUDA in patients with previously treated unresectable adenocarcinoma of the lung.

Biomarker studies will be conducted in parallel to the above studies with the goal of developing companion diagnostics to identify patients who would be most suitable for treatment with the BGB324/KEYTRUDA combination.

The clinical trials will be sponsored by BerGenBio while MSD will provide the trial with KEYTRUDA. The rights to the study results will be shared. No further details are disclosed.

BerGenBio is investigating BGB324 in multiple cancer indications based on preclinical and early clinical findings. Phase II studies with BGB324 as a single agent in relapsed acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS); and in combination with erlotinib (TARCEVA®) in advanced EGFR-positive NSCLC are in progress.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are delighted to enter this collaboration with MSD, a leader in developing novel cancer therapies. This new agreement gives us the opportunity to evaluate the clinical potential of BGB324 in combination with KEYTRUDA in advanced lung and breast cancer; two of the areas of significant unmet medical need. We believe that BGB324 is a unique drug candidate that addresses a critical cancer mechanism responsible for promoting immune evasion. We believe the clinical utility of BGB324 in combination with immunotherapies has enormous potential. BerGenBio is excited to advance BGB324 in combination with KEYTRUDA into Phase II trials and we anticipate results in mid-2018.”

About BerGenBio ASA
BerGenBio (Bergen, Norway) 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 central role of Axl kinase in promoting cancer spread, immune evasion and drug resistance in multiple aggressive liquid and solid cancers.

BerGenBio’s lead product, BGB324, is a selective, potent and orally available small molecule Axl inhibitor in Phase II clinical development in three major cancer indications. It is the only selective Axl inhibitor in clinical development. BGB324 is being developed by BerGenBio as a single agent therapy in acute myeloid leukaemia (AML)/myeloid dysplastic syndrome (MDS) and in combination with TARCEVA® (erlotinib) in advanced non-small-cell lung cancer (NSCLC); and in combination with KEYTRUDA® (pembrolizumab) in advanced NSCLC and triple negative breast cancer (TNBC) in collaboration with MSD.

The Company is also developing a diversified pre-clinical pipeline of selective Axl inhibitors including BGB149, anti-Axl monoclonal antibody.

For further information, please visit: www.bergenbio.com

About NSCLC
It is estimated that more than 220,000 new cases of lung cancer will be diagnosed in the US in 2017 and it is the leading cause of cancer death. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.

About TNBC
Breast cancer is the most common cancer in women – it is estimated that more than 250,000 new cases will be diagnosed in the US in 2017. 20% of breast cancers lack receptors for three common hormones (estrogen, progesterone and HER2) and are thus called triple-negative breast cancers (TNBC). Treatment options for TNBC are limited to intense chemotherapy, but despite therapy recurrences are frequent and aggressive. Consequently, novel treatment strategies for TNBC are of high need.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC.

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

David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedr.co.uk
+44 207 638 9571