Cancer Research U.K. and Cancer Research Technology (CRT), the charity's development and commercialization arm, have reached an agreement with Asterias Biotherapeutics, a California-based biotechnology company focused on regenerative medicine, to take forward Asterias' novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer.
AST-VAC2 represents the tenth treatment to enter Cancer Research U.K.'s Clinical Development Partnerships (CDP) scheme, with six having progressed into the clinic to date. CDP is a joint initiative between Cancer Research U.K.'s drug development office (DDO) and CRT, to develop promising anti-cancer agents which pharmaceutical companies do not have the resources to progress 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% 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, called AST-VAC1, which was derived from patients' blood cells and tested in prostate cancer and acute myeloid leukemia.
Unlike AST-VAC1, and other autologous (patient specific) vaccines that are developed from a patient's own cells, AST-VAC2 is derived from human embryonic stem cells (hESCs), meaning it can be produced on a large scale and stored ready for use, rather than having to produce a specific version of the drug for each patient.
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.
Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research U.K. will then produce the vaccine and conduct the phase I/II clinical trial in the U.K. 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.
Dr. Jane Lebkowski, president of R&D at Asterias, said, "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."
Nigel Blackburn, Cancer Research U.K.'s director of drug development, said, "Recent advances in cancer immunotherapy have demonstrated the exciting potential of these treatments to improve outcomes in devastating diseases such as lung cancer. Better treatment options for lung cancer are badly needed and it is through collaborations such as this that we can save more lives sooner."