immatics biotechnologies and its partner BioNTech AG reported that they are advancing the Glioma Actively Personalized VAccine Consortium (GAPVAC) into a Phase 1/2 clinical trial to investigate the concept of fully personalized therapeutic vaccines against cancer.
The consortium, headed by immatics biotechnologies, counts 14 organizations in the EU and U.S. as its members and is supported by the European Union Framework 7 (EU FP7) program with a €6 million grant. GAPVAC is the first initiative backed by the EU that aims to clinically develop biomarker-guided actively personalized vaccines (APVACs) that target glioblastoma, an aggressive form of brain cancer. Its concept is to treat patients with glioblastoma based on drugs produced on an individual basis according to the specific characteristics of their tumor as well as their immune systems.
The Phase 1/2 clinical trial will involve up to 30 patients newly diagnosed with glioblastoma. It will investigate the tolerability and efficacy of APVACS in inducing a specific and strong immune response against cancer. Participants in the trial will be given two vaccines specifically prepared for each individual. The first one will contain a select set of peptides based on the patient’s cancer tissue profile and the ability of their immune system to induce a response to its targets. The second vaccine will also comprise a chosen set of peptides based on a full next-generation sequencing (NGS)-based genetic analysis of the individual patient. The second vaccine will target mutations taking place in the cancer.
Both personalized vaccines will be designed using immatics and BioNTech’s biomarker-guided procedures. These will be administered following standard chemotherapy after surgery and upon the completion of initial radio-chemotherapy.
Dr. Harpreet Singh, CSO of immatics and Coordinator of the GAPVAC consortium, said, "The start of the GAPVAC clinical trial - based on an entirely new, personalized approach to treating cancer - is the result of the innovative science and the dedication of the excellent consortium members. For the first time, we have translated the specific characteristics of each individual patient's disease into a therapeutic drug candidate for further assessment in the clinic. The project members are driven by the real possibility of developing a truly personalized treatment for patients whose current options are extremely limited.”
Earlier this year, immatics also announced positive results in its Phase1 trial investigating its vaccine IMA950 for glioblastoma.