Lung cancer vaccine to enter clinical trials

Cancer Research UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, are to work with Asterias Biotherapeutics to take its novel immunotherapy treatment AST-VAC2 into clinical trials in non-small cell lung cancer.

AST-VAC2 is the tenth treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme, with six having progressed to market to date, including Temozolomide for brain cancer and Abiraterone Acetate for advanced prostate cancer.

CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and CRT, to develop promising anti-cancer agents which pharmaceutical companies cannot afford to take through early phase clinical trials.

AST-VAC2 is a non-patient-specific (allogeneic) cancer vaccine designed to stimulate patients’ immune systems to attack telomerase, a protein that is expressed in over 95 per cent of cancers but is rarely expressed in normal adult cells.

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

Unlike AST-VAC1, and other autologous vaccines that are developed from a patient’s own cells, AST-VAC2 is derived from human embryonic stem cells (hESCs), which means it has the benefit of being able to be produced on a large scale and stored ready for use, rather than a specific version of the drug being produced for each patient.

The AST-VAC2 trial 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 those with advanced forms of the disease.

Pedro Lichtinger, Asterias’ CEO, said, “AST-VAC2 is based on a specific mode of action that is complementary to, and potentially synergistic to, other immune therapies. We are delighted to partner with Cancer Research UK to advance this important platform through phase I/II clinical trials.”

Under the agreement, Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research UK will then produce the vaccine and conduct the clinical trials in the UK.

Asterias will then have an exclusive first option to acquire a licence 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 licence to Asterias’ intellectual property to continue the development and commercialisation of AST-VAC2 and related products in exchange for a revenue share to Asterias of development and partnering proceeds.

Dr Jane Lebkowski, president of R&D at Asterias, explained, “The use of human embryonic stem cells to derive allogeneic dendritic cells for cancer immunotherapy has the potential to dramatically improve the scalability, consistency, and feasibility of cellular cancer vaccines. We believe this collaboration will enable the acceleration of clinical studies of AST-VAC2 and the collection of important proof-of-concept data for the entire human embryonic stem cell-derived dendritic cell immunotherapy platform.”

Lung cancer is a leading cause of cancer death, with one of the lowest survival rates. Less than 10 per cent of people survive more than five years.

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