Asterias’ new immunotherapy treatment AST-VAC2 will enter into clinical trials in patients with non-small cell lung cancer (NSCLC). The new research initiative is the result of an agreement established between Cancer Research UK, Cancer Research Technology (CRT) and Asterias Biotherapeutics, Inc. (OTCBB: ASTY.)
Lung cancer remains the leading cause of cancer death in the United States and United Kingdom, respectively, with more than 150,000 people dying from the disease every year, in the US, and 35,000 people in the UK. This condition has the lowest survival rates of any cancer type. In the US, 25-50% of early-stage lung cancer patients and fewer than 20% of patients with advanced lung cancer have five year survival rates. Non-small cell lung cancer is the most common form of lung cancer, and accounts for 85% of all lung cancer cases.
Asterias Biotherapeutics has focused its technology on stem cell research, developing technologies capable of creating any cell type in the human body — a feature called pluripotency. Asterias’ initial focus is on two clinical stage programs, including oligodendrocyte progenitor cells (AST-OPC1) for spinal cord injuries and antigen-presenting allogeneic dendritic cells (AST-VAC2) for lung cancer.
Asterias’AST-VAC2 is a novel immunotherapeutic product consisting of human embryonic stem cell derived-mature dendritic cells (hESC-DCs) that are engineered to express telomerase and also designed as an “off-the-shelf” (i.e. a stored and ready for use) vaccine. This vaccine stimulates the immune response against tumor cells expressing telomerase. Telomerase activity is necessary for the immortality of most cancer types, but is rare and transient in most normal cells, meaning that telomerase inhibition appears to be an attractive target for cancer immunotherapy.
AST-VAC2 shows various advantages relative to the first generation dendritic cell vaccines, such as Dendreon’s Provenge® (sipuleucel-T) and Asterias’ AST-VAC1. Importantly, AST-VAC2 is a non-patient specific (allogeneic) vaccine (originated from hESC-DCs), contrary to AST-VAC1, which is manufactured on an autologous basis (developed from a patient’s own cells). This means that the former represents a scale-up platform vaccine with low cost, consistent manufacturing and on-demand availability, while AST-VAC1 and other autologous vaccines have higher costs of manufacture, product variability, and delayed availability of autologous products, such as patients’ blood cells.
The AST-VAC2 vaccine was developed following successful early phase clinical trials of AST-VAC1 in prostate cancer and acute myeloid leukemia (AML). The data from these trials support the safety and feasibility of dendritic cell-based telomerase immunotherapy, and showed telomerase-specific immune responses in 55% and 95%, respectively, of AML and prostate cancer patients. Moreover, in the prostate cancer trials, a decrease in prostate specific antigen (PSA) velocity, a measurement used to assess prostate cancer or other prostate abnormalities, as well as circulating tumor cells that correlated with the patient immune responses, was observed.
The AST-VAC2 trial will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase, and clinical outcome after AST-VAC2 administration in patients with resected, i.e. removal by surgery of part of the organ, early-stage lung cancer and advanced forms of the disease.
AST-VAC2 represents the tenth treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme, with six of them having successfully entered the clinic. CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anti-cancer agents from pharmaceutical companies that do not have resources to enter early phase clinical trials.
“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,” said Pedro Lichtinger, Asterias’ chief executive officer.
“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,” added Pedro Lichtinger.