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news.Asterias Biotherapeutics, a subsidiary of BioTime, has entered into an agreement with Cancer Research Technology (CRT), Cancer Research UK's development and commercialization arm, to evaluate its AST-VAC2 in a clinical trial as an immunotherapy to treat patients with non-small cell lung cancer (NSCLC).
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As part of the deal, Asterias will complete development of the manufacturing process for AST-VAC2, after which CRT will produce the vaccine and conduct the Phase I/II clinical trial in the UK.
The trial is designed to assess the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2.
The company’s new immunotherapy treatment 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 more than 95% of cancers.
Development of this cancer vaccine AST-VAC2 follows was based on data from early phase clinical trials of a similar, patient specific (autologous) Asterias vaccine, called AST-VAC1.
The Asterias vaccine was derived from patients’ blood cells and tested in prostate cancer and acute myeloid leukemia.
As AST-VAC2 is derived from human embryonic stem cells (hESCs) it can be produced on a large scale and stored ready for use, rather than producing specific version of the drug for each patient.
The company said that AST-VAC1 and other autologous (patient specific) vaccines were developed from a patient’s own cells.
The trial will also evaluate the clinical outcome after administration of AST-VAC2 in patients with resected early-stage lung cancer and in patients with advanced forms of the disease.
Asterias chief executive officer Pedro Lichtinger said the collaboration with Cancer Research UK’s Drug Development Office and CRT represents a major step in advancing the company’s dendritic cell platform for the potential benefit of patients.
"AST-VAC2 is based on a specific mode of action that is complementary and potentially synergistic to other immune therapies," Lichtinger said.
"We are delighted to partner with Cancer Research UK to advance this important platform through Phase 1/2 clinical trials. Cancer Research UK’s Drug Development Office has the global recognition of having the quality, capability and track record of successfully advancing development programs."
Following completion, 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 refuses to exercise this option, CRT have an option to secure a license to Asterias’ intellectual property to continue the development and commercialization of the vaccine as well as related products in return to a revenue share to Asterias of development and partnering proceeds.
Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.