CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity’s development and commercialization arm, have partnered with Asterias Biotherapeutics, Inc., to introduce Asterias’ novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer (NSCLC).
AST-VAC2 is an immunotherapeutic drug composed of human embryonic stem cell-derived mature dendritic cells (hESC-DCs) that are engineered to express telomerase, an enzyme that adds DNA sequence repeats to the end of DNA strands in the telomere regions.
This vaccine is designed to stimulate immune mediated responses against tumor cells expressing telomerase, which the majority of cancers express. However, telomerase is usually not expressed or is only transient in most normal adult tissues, making it a suitable candidate for cancer immunotherapy.
Previous studies of an autologous (patient specific) dendritic cell vaccine targeting telomerase (AST-VAC1) in prostate cancer and acute myelogenous leukemia (AML) had already originated positive data supporting the efficacy and safety of this type of immunotherapy, with telomerase-specific immune responses in 55% of AML and 95% of prostate cancer patients. Moreover, reductions in prostate specific antigen (PSA) velocity and circulating tumor cells, which correlated with patient immune responses, were observed.
Unlike AST-VAC1, AST-VAC2 will use human embryonic stem cells (instead of patient’s blood), which will allow the vaccine to be produced on a large scale and stored ready for use, instead of producing a specific version of the drug for each patient.
The clinical trial of AST-VAC2 will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2, along with clinical outcome after AST-VAC2 administration in patients with resected early-stage lung cancer and in patients with advanced forms of the disease.
“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”, Pedro Lichtinger, Asterias’ chief executive officer said in a PR Newswire press release.
Dr. Jane Lebkowski, president of research and development at Asterias, added, “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”.