BioTime Subsidiary, Asterias Biotherapeutics, And Cancer Research UK And Cancer Research Technology Partner For Clinical Trial Of Immunotherapy Vaccine For Lung Cancer

BioTime, Inc. (NYSE MKT:

) announced that its subsidiary Asterias Biotherapeutics, Inc.

has reached an agreement with Cancer Research UK and Cancer Research Technology (CRT), the charity's development and commercialization arm, to conduct a clinical trial 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, 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 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. Pedro Lichtinger, Asterias' chief executive officer, said: “The Asterias collaboration with Cancer Research UK's Drug Development Office and CRT represents a major step in advancing our proprietary 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. 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 in the United Kingdom. On completion of the 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. Dr. Jane Lebkowski, president of research and development 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.”