Date: 2014-10-14
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: immatics biotechnologies (Germany) BioNTech (Germany)
Product: GAPVAC-101
Action mechanism:
Disease: glioblastoma
Therapeutic area: Cancer - Oncology
Country: Germany
Trial
details: The clinical trial will recruit up to 30 newly diagnosed glioblastoma patients for the phase 1/2 trial and aims to show that APVACs are well tolerated and induce a strong and specific response against cancer, as well as demonstrating the feasibility of this highly innovative approach. Glioblastoma patients will be immunized with two vaccines specifically prepared for each patient. The first vaccine will be a tailored selection of peptides chosen from a pre-manufactured warehouse supplied by consortium partner BCN Peptides (Barcelona) consisting of approx. 70 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 vaccine will be based on full next-generation sequencing (NGS)-based genetic analysis of the patient and will comprise peptides newly manufactured by consortium partner University of Tuebingen. The latter vaccine will largely target mutations occurring in the cancer but not in healthy tissue. Both actively personalized vaccines will be designed according to biomarker-guided procedures performed at immatics and BioNTech and will be administered in addition to standard chemotherapy after surgery and initial radio-chemotherapy are completed. The clinical trial is being accompanied by an extensive biomarker program involving the Association of Cancer Immunotherapy (CIMT), a non-profit organization dedicated to the advancement of cancer vaccines. The clinical trial will be led by chief investigator Prof. Dr. Wolfgang Wick, University of Heidelberg, and co-led by Prof. Dr. Pierre-Yves Dietrich, University of Geneva, both internationally recognized experts in the treatment and immunology of brain cancer.
Latest
news: * On October 14, 2014, immatics biotechnologies GmbH and BioNTech AG announce that they are moving a novel concept of fully personalized therapeutic cancer vaccines, Glioma Actively Personalized VAccine Consortium (GAPVAC), into the clinic. The German national authority, the Paul-Ehrlich-Institute (PEI), has approved the start of a phase 1/2 study, GAPVAC-101, which applies for the first time the concept of treating glioblastoma patients based on drugs designed and manufactured for each patient individually according to specific characteristics of their tumor and immune system. The screening of first patients for the trial has commenced at the University Hospital of Heidelberg, Germany, and the University Hospital of Tuebingen, Germany. The complex manufacturing of the personalized vaccines 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). GAPVAC is the first EU-funded initiative aimed at clinically developing biomarker-guided actively personalized vaccines (APVACs) to treat patients with glioblastoma. The GAPVAC consortium includes 14 organizations in Europe and the United States and is led by immatics biotechnologies GmbH (Coordinator) and BioNTech AG (Vice Coordinator). The consortium is supported by a €6 million grant from the European Union Framework 7 (EU FP7) program.
