Cancer Research UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, have reached an agreement with Asterias Biotherapeutics, Inc. (OTCBB: ASTY), a biotechnology company in the emerging field of regenerative medicine and a subsidiary of BioTime, Inc. (NYSE MKT: BTX), to take forward their novel immunotherapy treatment AST-VAC2 into clinical trials with non small cell lung cancer patients.
This is the tenth treatment to enter Cancer Research UK's Clinical Development Partnerships* (CDP) scheme, with six having progressed into the clinic to date. CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, 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 percent of cancers but is rarely expressed in normal adult cells.
The vaccine was developed following successful early phase trials of a similar Asterias drug, called AST-VAC1, which was designed to treat acute myeloid leukemia and derived from patients’ blood cells.
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 either resected early-stage, or advanced forms of lung cancer.
Pedro Lichtinger, Asterias’ chief executive officer, said: “The Asterias collaboration with Cancer Research UK’s Drug Development Office represents a major step in advancing our proprietary dendritic cell platform for the potential benefit of patients.
“AST-VAC2 is at the forefront of cell-based immune therapies. It is based on a unique mode of action that is complementary and potentially synergistic to other immune therapies. 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. We are excited about the possibility of favorably impacting the lives of patients across multiple cancers and are proud to be working with Cancer Research UK.”
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 phase 1/2 clinical trial. On completion of the clinical trial, Asterias will have an exclusive first option to acquire the data from the trial. If Asterias declines this, CRT will then have an option to obtain a license 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, 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 hESC-DC immunotherapy platform.”
Nigel Blackburn, Cancer Research UK’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.”
For media enquiries please contact Ailsa Stevens in the Cancer Research UK\CRT press office on +44 203 469 8309 or, out-of-hours, the duty press officer on +44 7050 264 059.
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