Pharma Focus Asia
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Asterias’ Novel Immunotherapy Treatment AST-VAC2 Moves into Clinical Trials

The charity Cancer Research UK and its commercial arm Cancer Research Technology (CRT) have entered into an agreement with US biotech firm Asterias Biotherapeutics, a subsidiary of BioTime Inc., to conduct clinical trials of Asterias’ novel immunotherapy treatment AST-VAC2 in subjects with non-small cell lung cancer.

AST-VAC2 is a non-patient specific (allogeneic) cancer vaccine designed to stimulate patients’ immune systems to attack telomerase. AST-VAC2 is derived from human embryonic stem cells (hESCs) and can be produced on a large scale and stored ready for use.

Telomerase is a protein that is expressed in over 95 per cent of cancers but is rarely expressed in normal adult cells.

The trial of AST-VAC2 will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2, and clinical outcome after AST-VAC2 administration in patients with resected early-stage lung cancer and in patients with advanced forms of the disease.

Under the terms of the deal, Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research UK will then produce the vaccine and conduct Phase I/II clinical trial in the UK. On completion of clinical trial, Asterias will have an exclusive first option to acquire a license to the data from the trial on pre-agreed terms including an upfront payment, milestones and royalties on sales of products. If Asterias declines this option, CRT will then have an option to obtain a license to Asterias’ intellectual property to continue the development and commercialization of AST-VAC2 and related products in exchange for a revenue share to Asterias of development and partnering proceeds. No financial details were disclosed.

The vaccine was developed following successful early phase clinical trials of a similar, patient specific (autologous) Asterias vaccine, called AST-VAC1, which was derived from patients’ blood cells and tested in prostate cancer and acute myeloid leukemia.

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