EU funds innovative personalised brain cancer trials
Novel personalised brain cancer vaccines are entering phase I/II trials thanks to a €6 million grant from the EU FP7 programme.
The studies are a result of work by the Glioma Actively Personalised Vaccine Consortium (GAPVAC), a group of 14 organisations in Europe and the US, which was launched in 2013 to create, manufacture and develop actively personalised vaccines (APVACs) tailored to the characteristics of a specific patient’s tumour and immune system.
Its approach combines the latest technologies, including next-generation sequencing (NGS), high-sensitivity mass spectrometry and innovative immune-monitoring to generate an optimal therapy for each individual.
Immatics Biotechnologies and BioNTech will run the trials, GAPVAC-101, which have been approved by German regulator the Paul Ehrlich Institute (PEI).
The first of up to 30 newly diagnosed glioblastoma patients are being screened for the trial at two hospitals in Germany. They will be immunised with two vaccines specifically prepared for each candidate. The first vaccine will be a tailored selection of peptides based on the target profile of the individual cancer tissue and the ability of the individual’s immune system to induce a response to the selected targets. The second will be based on full NGS-based genetic analysis of the patient and will largely target mutations occurring in the cancer but not in healthy tissue.
Both will be administered in addition to standard chemotherapy after surgery and initial radio-chemotherapy are completed.
The vaccine manufacture will be performed by the GMP unit of the University of Tuebingen in close cooperation with the GMP and Core Services platform of the German Cancer Consortium (DKTK).
Glioblastoma is an aggressive form of brain cancer with poor prognosis and a high unmet need. The limited treatments available today have minimal effect on overall survival.
Trial chief investigator Prof Wolfgang Wick, chair of the Neurology Clinic at the University of Heidelberg, said: “The trial concept is exactly the right combination of exceptional science and a rigorous protocol for a disease for which over-simplified strategies have failed in the past. The scientific approach in this trial offers the chance for each involved patient to benefit clinically. In addition, we will learn a lot for future efforts in immunotherapy, bridging the precision of genomic medicine and immunotherapy.”
Another brain cancer vaccine, DCVax-L, from Northwest Biotherapeutics, has been made available in Germany under an early access scheme known as ‘hospital exemption’. The company plans to start selling it before the end of the year, once reimbursement negotiations with the German authorities are concluded.
In September, the UK’s Department of Health granted DCVax-L ‘Promising Innovative Medicine’ (PIM) status, based on data from two phase I/II trials. PIM is the first step in the Early Access to Medicines Scheme (EAMS), which it launched in April.
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