BerGenBio Reports Promising BGB324 Phase I/II Monotherapy Data in Patients with Lung Cancer at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium

Long term disease stabilisation observed highlighting importance of AXL in NSCLC 

Bergen, Norway, November 29, 2016 – BerGenBio AS (“BerGenBio” or the “Company”), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, announced that clinical data from its lead product candidate BGB324, a first-in-class selective Axl kinase inhibitor, was presented today at the 28th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium Meeting in Munich. 

The data demonstrated that BGB324 can be safely administered to patients with advanced non-small cell lung cancer (NSCLC) at doses that achieve durable disease control. The demonstrated tolerability and clinical activity indicate a unique mechanism-of-action of BGB324 in patients with NSCLC. BerGenBio is now analysing data from the erlotinib combination therapy arm of the study. 

“Following this promising monotherapy data, we are now analysing the effects of erlotinib in combination with BGB324 in patients with EGFR-driven NSCLC and expect to present the results before the end of 2017,” said Richard Godfrey, Chief Executive Officer of BerGenBio. “We believe these data further demonstrate the importance of targeting AXL in lung cancer treatment strategies.”

Dr. Lauren Byers, Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston presented a poster entitled: A Phase I/II and pharmacokinetic study of BGB324, a selective AXL inhibitor as monotherapy and in combination with erlotinib in patients with advanced Non-Small Cell Lung Cancer (NSCLC) as part of the session "Molecular Targeted Agents I". 

In the study, BGB324 was administered at an oral loading dose (600 mg) on days one and two, followed by a daily maintenance dose (200 mg) to eight patients with previously treated advanced NSCLC. Two of the eight patients achieved stable disease for at least nine months. Treatment was well tolerated with no patients discontinuing therapy as a result of toxicities.  Exposure to BGB324 was accompanied by increases in patient plasma levels of soluble AXL receptor, an important pharmacodynamic readout. 

“It is very encouraging that BGB324 was well tolerated and showed clinical activity as a monotherapy in this heavily pre-treated lung cancer population,” commented Dr. Byers. “This supports the central role of AXL in lung cancer, and I am looking forward to advancing the BGB324-erlotinib combination study arm. BGB324 could become a new treatment option in NSCLC.”

BGB324 is the only selective AXL inhibitor currently in clinical development. In addition to the erlotinib combination study, Phase Ib clinical trials are underway with BGB324 as single agent and in combination in acute myeloid leukaemia (AML) as well as in combination with docetaxel in non-small cell lung cancer (NSCLC).


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About BGB324

BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition (EMT), which is a key driver in immune evasion, drug-resistance and metastasis.

About BerGenBio AS

BerGenBio AS is a clinical stage biopharmaceutical company focused on developing first-in-class drugs for aggressive cancers. The company is a world leader in understanding the biology of epithelial-mesenchymal transition (EMT), a widely recognised key pathway in immune evasion, acquired cancer drug-resistance and metastasis. BerGenBio AS is founded on proprietary platform technology, CellSelect™, to identify and validate novel drug targets and biomarkers. The company has progressed its lead drug candidate BGB324, an EMT inhibitor, into clinical trials in AML and NSCLC, while pursuing the pre-clinical development of additional compounds and proprietary EMT drug targets.

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