Asterias, CRUK Team Up For Testing New Stem Cell Based Cancer Vaccine
By C. Rajan, contributing writer
Asterias Biotherapeutics, a subsidiary of BioTime, announced last week that it has entered an agreement with Cancer Research UK (CRUK) and Cancer Research Technology (CRT) to conduct a clinical trial of Asterias' novel immunotherapy cancer vaccine, AST-VAC2, for non-small cell lung cancer.
AST-VAC2 is an allogeneic dendritic cell-based cancer vaccine, which is derived from human embryonic stem cells (hESCs). AST-VAC2 is designed to stimulate an immune system response to attack telomerase, a protein expressed in over 95 percent of cancer cells, but not in normal cells, thus making it an attractive target for cancer therapies.
AST-VAC2 is not patient specific (allogeneic) as it is derived from human embryonic stem cells, so the vaccine can be produced on a large scale and stored ready-for-use, unlike other patient specific (autologous) cancer vaccines in development which require preparing a specific version of the treatment for each patient.
Under the terms of its agreement with CRUK, Asterias will develop the manufacturing process for AST-VAC2, and CRUK will produce the vaccine and conduct the phase 1/2 clinical trial in the U.K. After the completion of the clinical trial, Asterias will have the exclusive first option to acquire a license to the data from the trial on pre-agreed terms. If Asterias declines this option, then CRT can obtain a license to Asterias' intellectual property to continue working on the AST-VAC2, in exchange for a revenue share to Asterias.
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.”
The goals of the phase 1/2 clinical trial of AST-VAC2 are to evaluate (a) the safety and toxicity of the vaccine, (b) the stimulation of patient immune responses to telomerase and AST-VAC2, and (c) the clinical outcome after AST-VAC2 administration in patients with resected early-stage lung cancer and in patients with advanced forms of the disease.
Lung cancer has one of the lowest survival rates and is responsible for the highest number of cancer related deaths. According to Asterias, lung cancer causes over 150,000 deaths in the U.S. and 35,000 deaths in U.K. annually. Asterias is developing stem cell-based therapies for lung cancer as well as for multiple sclerosis, stroke, and spinal cord injuries.
Asterias' stem cell products also received a nod from the U.S. FDA recently. Just three weeks ago, Asterias announced that it has received FDA clearance to begin the clinical trial on its AST-OPC1 oligodendrocyte progenitor cells (OPCs) experimental therapy, to treat spinal cord injuries. The company plans to begin the clinical trial in early 2015. Asterias has raised about $13 million in equity financing recently to support the clinical development of the AST-OPC1 and AST-VAC2 therapies.