Lung Cancer Vaccine candidate Launches Clinical Study

Asterias Biotherapeutics AST-VAC2 vaccine candidate dendritic cells are engineered to express a modified form of a protein called telomerase

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An innovative treatment vaccine has launched a phase I clinical trial for patients with non-small cell lung cancer (NSCLC). 

This study is important since about 80 percent of lung cancers are NSCLC.

Lung cancer starts when cells of the lung become abnormal and begin to grow. As more cancer cells develop, they can form a tumor and spread to other areas of the body.

Previous NSCLC vaccination trials did not meet their study’s primary endpoints but showed potential patient benefits.

If shown to be safe and effective, this vaccine candidate (AST-VAC2) could be used as an additional treatment for patients who no longer have advanced disease, but whose lung cancer is at high risk of coming back, or in combination with other treatments for patients with advanced disease.

This small, early-stage study will demonstrate the feasibility of the manufacturing process at a clinical scale as well as testing whether it’s a safe and effective treatment for patients with NSCLC.

The trial is open to patients who are HLA2+ with advanced NSCLC (metastatic or locally advanced disease) in the first instance, with the expansion phase open to patients who are HLA A2+ and disease-free after treatment for NSCLC.

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The efficacy of AST-VAC2 will be assessed by 2-year overall survival, time to relapse and measurement of immune response.

This study is proceeding under a collaboration agreement between Cancer Research UK and Asterias Biotherapeutics Inc.

Dr. Nigel Blackburn, Cancer Research UK’s director of drug development, said in a press release, “This vaccine trial is a pioneering approach to improving treatment for lung cancer, the biggest cause of cancer death worldwide.”

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The vaccine is made from dendritic cells that are able to kick-start the body’s immune system. They present molecules called antigens on their surface and orchestrate a T-cell immune response against cells bearing the same antigens.

AST-VAC2 dendritic cells are engineered to express a modified form of a protein called telomerase, which is almost always present at high levels in various types of cancer cells, but rarely found in healthy cells.

This modified form of telomerase, called hTERT, can stimulate a natural immune response targeted at cancer cells.

High levels of telomerase are a common feature of many cancers, so AST-VAC2 has the potential to become an immunotherapy option for other types of cancer beyond NSCLC.

Previous dendritic cell therapies have been made using patients’ own cells, but this process is costly, slow, and inefficient.

Researchers will test blood samples taken at various time points to assess whether the patient’s immune system is capable of mounting an immune response against hTERT.

By using a pioneering approach of growing mature dendritic cells from a single human embryonic stem cell line in the laboratory, it’s hoped AST-VAC2 will overcome these challenges.

Professor Christian Ottensmeier, the chief investigator for the trial and head of the Southampton Experimental Cancer Medicines Centre, said: “Vaccines that boost the immune system to recognise and fight cancer could become a routine part of treatment for certain patients in the future, but we need to make them cheaper and easier to produce.”

“With its potential to be used off-the-shelf, AST-VAC2 is an exciting development in the rapidly evolving field of immunotherapy,” said Ottensmeier.

Cancer Research UK will manage the initial clinical development of AST-VAC2. Under the agreement, Asterias transferred its innovative cell therapy manufacturing process to Cancer Research UK.

Experimental Cancer Medicine Centres are jointly funded by Cancer Research UK, the National Institute for Health Research in England and the Departments of Health for Scotland, Wales and Northern Ireland.