Asterias transfers AST-VAC2 manufacturing processes to Cancer Research UK
Posted: 21 January 2016 | Victoria White | No comments yet
AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells…
AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These allogeneic AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumour cells, but rarely found in normal cells. The modified form of telomerase permits enhanced stimulation of immune responses to the protein. The AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase which will target tumour cells.
To accelerate clinical development of AST-VAC2, Asterias has an ongoing partnership with Cancer Research UK and Cancer Research Technology to execute the first clinical trial of AST-VAC2. As part of this partnership, Cancer Research UK will perform cGMP manufacture of AST-VAC2 at their Biotherapeutics Development Unit. In preparation for cGMP production, Asterias developed the production process for AST-VAC2 to support the transfer and further scale-up in Cancer Research UK’s manufacturing facility for the Phase 1/2 clinical study. To that end, Asterias has completed transfer of the AST-VAC2 manufacturing process information to Cancer Research UK. Cancer Research UK is now verifying and scaling up the production of AST-VAC2 in their facility in preparation for pilot and full cGMP campaigns.
Phase1/2 trial in NSCLC to be managed and funded by CDD
Upon successful completion of AST-VAC2 production campaigns, Cancer Research UK’s Centre for Drug Development (CDD) will submit a Clinical Trial Authorisation application to the UK regulatory authorities for a Phase 1/2 clinical trial in non-small cell lung cancer, which will be sponsored, managed and funded by CDD. The clinical trial will examine the safety, immunogenicity and activity of AST-VAC2 and position the immunotherapy to be tested for numerous clinical indications.
Commenting on AST-VAC2, Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: “This drug could potentially treat most tumour types as it targets the telomerase protein – which is faulty in 95% of all cancers. The treatment’s design means it could also boost the effects of other immunotherapies and be used in combination.
“Lung cancer is the biggest cancer killer so we desperately need to find new treatments for the disease. And we’re pleased to be working with Asterias Biotherapeutics to develop this new treatment and to test it in clinical trials for non-small cell lung cancer for the first time.”
Cancer Research UK