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BerGen Bio develops novel treatment for leukemia

Oslo Cancer Cluster member BerGenBio announce that preclinical studies on the agent BGB324 may be effective as new treatment for patients with drug resistant Chronic Myeloid Leukemia (CML). The data was presented in a poster at the Annual Meeting of the American Society of Hematology (ASH) early December.

It is estimated that CML accounts for approximately 10% of all new cases of leukemia. The disease 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.

CML is now largely treated with targeted drugs called tyrosine kinase inhibitors (TKIs), which have led to improved long term survival rates and allow most patients to have a good quality of life when compared to the former chemotherapy drugs. Novartis’ Gleevec (imatinib) and Tasigna (nilotinib), and Bristol Myer Squibb’s Sprycel (dasatinib) are examples of these new targeted drugs.

Effective against drug resistance
However, long term therapy with the new treatment can result in the development of drug resistance and new mutations. BerGenBio’s preclinical in vivo studies shows that BGB324 may be effective as therapy taken alone, in leukemia and solid tumors, and is very effective in preventing and reversing acquired resistance to existing therapies.

The results are based on work conducted by Dr. Sonja Loges’ group at the University Comprehensive Cancer Center in Hamburg: “There is a significant unmet need for novel therapies that can address drug-induced resistant cancers”, comments Dr. Sonja Loges.

“The results of the preclinical studies support our belief that BGB324 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.”

BerGenBio’s cancer drug BGB324 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.

Read the press release on BerGenBio’s website and the abstract in full on the American Society of haematology website.

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. BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase.

About BerGenBio AS
BerGenBio AS is a biopharmaceutical company located in Bergen, Norway and member of Oslo Cancer Cluster. 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.

Life Tech & Novartis to develop immunetherapy against leukemia

Life Technologies Corporation has signed a long-term supply and exclusive licensing agreement with Novartis for immunotherapeutics involving T cells modified to express chimeric antigen receptors for the treatment of cancer. Both Novartis and Life Technologies are member of Oslo Cancer Cluster.

Life Technologies (former Dynal) will provide the company’s proprietary technology, Dynabeads® CD3/CD28 CTS™, which possess unique biological properties suited to production of active, therapeutically relevant immune system cells. The agreement includes rights to use Life Technologies’ intellectual property to perform the resulting therapy, and is exclusive for use in the field of chimeric antigen receptors for the treatment of cancer.

“The collaboration with Novartis highlights the distinct capabilities that Life Technologies can provide in the therapeutic realm,” said Greg Lucier, chairman and chief executive officer of Life Technologies. “Taken with our previous announcements of companion diagnostic collaborations, the current agreement demonstrates how Life is uniquely positioned to facilitate drug development through alliances with pharma.” Chimeric antigen receptor T cell based immunotherapy constitutes a novel, individualized method of combating cancers.

Immunotherapeutic treatment of child leukemia
Novartis is working to commercialize technology developed at the University of Pennsylvania that has demonstrated startling efficacy in research studies. In two 2011 publications University of Pennsylvania researchers described application of immunotherapy in three patients, all of whom experienced durable complete or partial remission of their cancers within three to four weeks of treatment. A 2013 publication in the New England Journal of Medicine described complete responses with one ongoing in two children with leukemia.

The personalized therapy consists of removing blood cells from cancer patients; isolating and activating T cells; genetically modifying the T cells thereby programming those cells to recognize and attack cancer cells; expanding the T cells; and, lastly, introducing those cells back into the body so the patient’s immune system can take over. Under the terms of the current agreement, Life Technologies’ Dynabeads® CD3/CD28 CTS™, will be used to isolate, activate and expand the T cells.

“Dynabeads ® CD3/CD28 CTS™ have unique properties that are ideal for producing a robust immunotherapeutic,” said Oystein Aamellem, head of Cellular Medicine at Life Technologies. “Not only do the beads assure that T cells are separated from any unwanted cells, it also triggers the T cells to reproduce in a natural and controlled manner, ensuring a therapeutically relevant population is transferred back into the patient.”

Read an article about one of these children featured in the New York Times here.