BerGenBio Initiates NSCLC Clinical Trial With BGB324 in Combination With erlotinib

BERGEN, Norway, June 10, 2015 /PRNewswire/ --

BerGenBio AS ("BerGenBio" or the "Company"), an oncology biopharmaceutical company, today announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in patients with Stage IIIb and Stage IV non-small cell lung cancer (NSCLC) in erlotinib-sensitive and refractory patients who have an activating EGFR mutation, is now underway at the University of Texas MD Anderson Cancer Center, Houston, Oncology Partners, Houston, and at UT Southwestern Medical Center, Dallas, Texas, USA.

This multi-centre trial, which will enrol 66 patients, is designed to: determine the maximum dose of BGB324 that can be safely administered in combination with erlotinib; identify the recommended Phase 2 dose of BGB324; and evaluate the safety, pharmacokinetics and clinical activity of BGB324 in combination with erlotinib.

Professor John V. Heymach, MD, PhD, Professor and Chair, Thoracic/Head & Neck Medical Oncology at University of Texas MD Anderson Cancer Center said:

"Acquired resistance to erlotinib curtails the clinical utility of this drug in the treatment of NSCLC. BGB324's novel mechanism holds tremendous potential for improving the treatment outcomes in this setting and I am excited to be able to offer my patients the drug in this clinical trial and look forward to reporting the outcomes in due course."

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"The initiation of the NSCLC trial demonstrates our continuing clinical progress with BGB324, our first-in-class selective Axl inhibitor. This is our second Phase 1b trial following the initiation of the acute myeloid leukaemia trial in November 2014 and we look forward to reporting results from these studies later in 2015."

About the BGBC004 trial 

BGBC004 is a multi-centre, three arm, Phase 1b trial which will enrol 66 patients with Stage IIIb and Stage IV non-small cell lung cancer (NSCLC). The first arm is designed to determine the maximum dose of BGB324 that can be safely administered in combination with erlotinib administered at the approved oral dose level of 150 mg daily and aims to identify the recommended Phase 2 dose of BGB324. The second arm has a two-stage design to evaluate the safety, pharmacokinetics and clinical activity of BGB324 in combination with erlotinib in patients with an activating EGFR mutation who have progressed after receiving prior erlotinib. The third arm will evaluate the safety, pharmacodynamics and clinical activity of BGB324 when administered in combination with erlotinib in patients with an activating EGFR mutation who have received at least twelve weeks of erlotinib without disease progression. ClinicalTrials.gov identifier: NCT02424617.

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 drug-resistance and metastasis.

About non-small cell lung cancer 

Non-small cell lung cancer (NSCLC) is an aggressive form of cancer, classified as any type of epithelial lung cancer other than small cell lung carcinoma. About 85% to 90% of lung cancers are NSCLC. There are three primary types of NSCLC: adenocarcinoma, squamous cell carcinoma and large cell carcinoma. The American Cancer Society estimates that 228,190 new cases of NSCLC will be diagnosed in 2013. BerGenBio and others have shown that a primary mechanism of drug resistance in NSCLC is mediated by Axl and this resistance can be blocked by inhibiting Axl with BGB324.

About BerGenBio AS 

BerGenBio AS is a clinical stage biopharmaceutical company. The company is committed to developing innovative therapeutics that inhibit EMT, prevent the formation of cancer stem cells and disrupt the cellular mechanisms that drive acquired cancer drug resistance. The company is founded on proprietary platform technology, CellSelect™, which uses information from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is the first compound in BerGenBio's pipeline to enter clinical trials in AML and NSCLC, with additional compounds and drug targets at different stages of preclinical development. http://www.bergenbio.com

SOURCE BerGenBio