ACTIVELY PERSONALIZED VACCINES
The vision of therapeutic cancer vaccines is to effectively target and destroy all tumor cells while leaving healthy cells unharmed. Current strategies based on target structures on the tumors, i.e. antigens found commonly in a high proportion of cancer patients. Recently, several clinical trials showed good safety and promising signs of clinical activity of such cancer vaccines. GAPVAC is taking cancer vaccines to the next level by assessing the individuality of each patient´s disease to utilize the full antigenic potential of immunotherapy. GAPVAC`s goal is to deliver to patients a novel class of medicine: Actively Personalized Vaccines (APVACS), which are actively tailored to the tumor characteristics of each individual patient.
PERSONALIZED VACCINE DESIGN
To generate a vaccine specifically tailored to a single patient, the disease of the respective patient has to be analyzed prior to treatment. By combining the latest state-of-the-art technologies including next-generation sequencing (NGS), mass spectrometry, computational medicine algorithms, and immunology, our scientists generate a fingerprint of the individual tumor. This fingerprint is aimed to be used by the immune system to selectively destroy cancer cells without harming healthy tissues. In this project, it is planned to design and manufacture an Actively Personalized Vaccine (APVAC) for each individual patient within a few months after the initial surgery.
Glioblastoma is the most aggressive form of brain cancer, unfortunately with only limited therapeutic options and only very poor prognosis. Thus, there is an urgent medical need for new therapeutic approaches. Previous experience in first vaccination trials has indicated encouraging immune responses to vaccinations in these patients.
The GAPVAC clinical trial is planned to start in 2014. First, the tumor surgically resected of newly diagnosed glioblastoma patients will be analyzed. During this time, patients start their standard therapy (radiochemotherapy). As soon as the personalized vaccine is available, patients will be repeatedly vaccinated on top of the standard therapy.
MONITORING THE IMMUNE SYSTEM
Patient care and monitoring of the health status of each patient is mandatory in the GAPVAC clinical trial. Apart from this, the latest technologies to analyze the specific immune responses induced by the personalized vaccine will be thoroughly analyzed. Immune responses are monitored in the blood – if possible – also within the tumor of each patient. To assess the biological activity of the novel GAPVAC approach, immune responses are investigated for each patient before and during vaccination.
GAPVAC is led by two highly innovative biotechnology companies based in Europe: immatics biotechnologies GmbH (Coordinator) and BioNTech AG (Vice Coordinator) who are dedicated to applying the best science for the benefit of patients. Ten academic centers in Europe and the US will recruit patients and collect scientific data for the GAPVAC clinical trial. Academic centers are located in Barcelona (Spain), Copenhagen (Denmark), Geneva (Switzerland), Glasgow (UK), Haifa (Israel), Heidelberg (Germany), Leiden (The Netherlands), Pittsburgh (USA), Southampton (UK) and Tuebingen (Germany). The personalized vaccine will be manufactured at BCN Peptides (Barcelona, Spain) and at the University of Tuebingen (Tuebingen, Germany). Moreover, results will be disseminated by the Association for Cancer Immunotherapy (CIMT) who will also contribute to the scientific analysis.
The GAPVAC project is funded by the 7th Framework Programme (2012) of the European Commission under the “Health” call. About six million EUR will be provided by the EU.