|Asterias Biotherapeutics Announces Positive Outcome from Safety Review Committee for AST-VAC2; Recommends Continuation of Clinical Trial in Non-Small Cell Lung Cancer (NSCLC)|
"Based on its review of all available study data after five doses in the first patient, the Safety Review Committee’s recommendation to continue the trial without modification reaffirms our belief that AST-VAC2 is safe and well-tolerated," commented Dr
The Safety Review Committee reviewed all of the accumulated safety data generated to date for the first patient in Arm A (advanced disease), who by the time of the review had received five, weekly doses of 10 million AST-VAC2 cells.
As specified in the AST-VAC2 clinical trial protocol, the Safety Review Committee meets on a dosing-driven basis to review safety and tolerability data from the ongoing trial. The committee is comprised of a group of medical and scientific experts and is responsible for reviewing and evaluating patient safety data in order to safeguard the wellbeing of trial participants.
AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase invokes enhanced stimulation of immune responses to the protein. Similar to an earlier, Asterias-sponsored, hematological cancer program which provided proof-of-concept data in [AML], the AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. AST-VAC2’s mode of action is complementary to and potentially synergistic with other immune therapies such as checkpoint inhibitors or other immune pathway inhibitors.
About Non-Small Cell Lung Cancer and the AST-VAC2 Trial
Lung cancer (both small cell and non-small cell) is the leading cause of cancer-related death, accounting for about one-quarter of all cancer deaths and more than colorectal, breast, and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers, according to the
As currently designed, the first AST-VAC2 clinical trial will enrol up to 24 subjects into one of two cohorts, depending on the stage of their non-small cell lung cancer. The first cohort will evaluate AST-VAC2 in up to 12 subjects with advanced non-small cell lung cancer. Subjects in this cohort, who carry the major histocompatibility gene, HLA-A2, will receive six weekly injections of AST-VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival. Assuming safety is demonstrated in the first cohort, enrolment will advance to a second cohort. In the second cohort, early stage subjects who have had successful resection of their tumour with no evidence of metastasis will be enrolled. Up to 12 subjects in this second cohort who carry the major histocompatibility allele HLA-A2 will receive six, weekly injections of AST-VAC2 and will be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse. Both cohorts will also have a control group consisting of patients that meet all inclusion/exclusion criteria for the study but who do not have the HLA-A2 marker. Subjects will be followed for one year for immune response to telomerase and for 2 years for the survival endpoints. The supply of AST-VAC2 to be used in this trial is being manufactured by Cancer Research UK’s Biotherapeutics Development Unit.
About Cancer Research UK’s Clinical Development Partnerships
Cancer Research UK’s Clinical Development Partnerships (CDP) is an initiative that aims to develop promising anti-cancer agents from companies that are not able to take them through early phase clinical trials themselves. Under the scheme,
About Cancer Research UK’s Centre for Drug Development