BioNTech and immatics biotechnologies 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 I/II 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 E.U.-funded initiative aimed at clinically developing biomarker-guided actively personalized vaccines (APVACs) to treat patients with glioblastoma. Glioblastoma, an aggressive form of brain cancer with poor prognosis, has a high unmet need and the limited treatments available today have minimal effect on overall survival. The GAPVAC consortium includes 14 organizations in Europe and the U.S. and is led by BioNTech (vice coordinator) and immatics biotechnologies (coordinator). The consortium is supported by a $7.7 million grant from the European Union Framework 7 (EU FP7) program.
The clinical trial will recruit up to 30 newly diagnosed glioblastoma patients for the phase I/II 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 BioNTech and immatics 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.
This novel approach marks a fundamental paradigm shift from optimizing novel treatments for cohorts of patients towards optimizing drugs for each individual patient. The GAPVAC clinical trial mark a major change in the therapeutic management of cancer patients since the approach is suited to provide a truly individualized treatment."