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BerGenBio AS Release: Data Highlights BGB324 As A Potential Novel Treatment Option For Drug Resistant Chronic Myeloid Leukemia

12/17/2013 9:37:31 AM

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Bergen, Norway, December 17, 2013 – BerGenBio AS (“BerGenBio” or the “Company”), an oncology biopharmaceutical company, announces that preclinical data demonstrating that BGB324 has potential application as a novel treatment for Chronic Myeloid Leukemia (CML), was presented in a poster at the Annual Meeting of the American Society of Hematology (ASH), which took place on December 7-10, 2013.

The results suggest that BGB324 may be effective as monotherapy in treating patients with drug-resistant CML as a result of exposure to Abelson kinase (Abl) inhibitors such as imatinib, nilotinib and dasatinib, (Novartis’s Gleevec and Tasigna, and Bristol Myer Squibb’s Sprycel) which are widely used as first line therapy in patients. Long term therapy with these agents can result in the development of resistance and new mutations. Overexpression of the Axl tyrosine kinase is known to confer resistance to treatment with imatinib. Treatment with Abl inhibitors whilst successful in eradicating malignant cells from the blood does not kill the leukemic stem cells which remain active in the bone marrow necessitating life-long treatment with these agents. In contrast treatment with BGB324 was effective in inducing programmed cell death in CML stem cells located in the marrow. The results also revealed that treatment with BGB324 was effective in treating animals infected with CML cells expressing the T315I mutation of ABL which is resistant to treatment with currently approved drugs. The data further underscores the potential of BGB324 in addressing the spread of leukemias and other resistant cancers whose biology is driven by Axl expression.

BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase. Preclinical in vivo studies have shown that BGB324 has both single agent activity in leukemia and solid tumors and is very effective in preventing and reversing acquired resistance to existing therapies including cytotoxics, protein kinase inhibitors and other targeted therapies. It is the only selective Axl inhibitor in clinical development having recently completed a phase Ia clinical trial. Phase Ib clinical trials are planned in acute myeloid leukemia and non-small cell lung cancer in 2014.

The poster presented at ASH was based on work conducted by Dr. Sonja Loges’ group from the Department of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology and from the Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf.

Sonja Loges, MD PhD, commented: “There is a significant unmet need for novel therapies that can address drug-induced resistant cancers. The results of the preclinical studies presented in this poster support our belief that BGB324, a selective inhibitor to Axl poised for clinical development in acute myeloid leukemia and non-small cell lung cancer, could also offer a promising potential new treatment option for chronic myeloid leukemia, especially in patients that are resistant to the current standard of care. This data further reinforces our hypothesis that Axl plays a critical role in the emergence of a number of drug resistant hematological and solid cancers.”

The abstract can be found in full on the American Society of haematology website at the following URL:

For further information please contact:

BerGenBio AS +47 917 86 304

Richard Godfrey, CEO

Media enquiries

FTI Consulting +44 (0)20 7831 3113

Simon Conway / Stephanie Cuthbert

About the Axl kinase receptor

Axl is a member of the Tyro3, Axl, Mer receptor (TAMR) tyrosine kinase family and is a fundamental receptor to cancer biology. It plays a crucial role in the epithelial-mesenchymal transition (EMT) which is a key driver of metastasis (cancer spread) and a mechanism of drug-resistance. The Axl receptor is regarded as one of the most promising new therapeutic targets for cancer drug development.

About Chronic Myeloid Leukemia

The American Cancer Society reported that there were 5920 new cases of CML reported in the United States and 610 deaths from the disease in 2013. It is estimated CML accounts for approximately 10% of all new cases of leukemia and that 1 in 588 people will be diagnosed with CML during their lifetime. CML originates from malignant stem cells in the bone marrow and ultimately spreads throughout the body developing into a rapidly progressive and almost uniformly fatal acute leukemia.

About BerGenBio AS

BerGenBio AS is a biopharmaceutical company located in Bergen, Norway. The company is committed to developing first in class therapeutics that inhibit EMT, preventing the formation of cancer stem cells and disrupting the important mechanisms of acquired cancer drug resistance. The company is founded on proprietary platform technology called 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, with additional compounds and drug targets at different stages of preclinical development.

About the Department of Hematology, Oncology and Bone Marrow Transplantation with Section Pneumology, University Comprehensive Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf

The Department of Hematology, Oncology and Bone Marrow Transplantation with section Pneumology is part of the Oncologic Center of the Medical University Hospital Hamburg, of the Hubertus Wald Tumorzentrum and of the University Comprehensive Cancer Center Hamburg (UCCH). It has been recognized as a Center of Excellence in Oncology (Onkologisches Spitzenzentrum) by the German Cancer Aid (Deutsche Krebshilfe) since 2007. In the UCCH more than 7000 inpatients and more than 10000 outpatients are treated per year. The Department of Hematology and Oncology administers chemotherapy to more than 2500 patients and treats about 1200 patients in 134 clinical trials per year. Patients with hematologic malignancies constitute about 23% of patients treated in the department. In addition the Department hosts extensive programs for basic and translational cancer research.

About the Institute of Tumor Biology, University Comprehensive Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf

The Department of Tumor Biology is part of the Center of Experimental Medicine and Member of the University Cancer Center Hamburg. Its research is dedicated to the identification and characterization of tumor cells that have disseminated from the primary tumor and may give rise to overt metastases in cancer patients. The early detection of "dormant" tumor cells is important to estimate the prognosis of patients with breast cancer and other carcinomas. It may improve the individual management of targeted therapy options, and in the long term has the potential to contribute to the development of new innovative cancer therapy approaches. To perform excellent translational research, the Institute of Tumor Biology collaborates with other institutes within the UKE, as well as other national and international organizations (Europe, Japan, USA). The Institute also leads extensive joint research projects and organizes international congresses about dormancy and dissemination of tumor cells.

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