immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company dedicated to developing advanced immunotherapies that are active against cancer, and BioNTech AG, a biopharmaceutical company develops innovative therapeutics and biomarker-based diagnostics, have announced 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. 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 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.

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.

Prof. Dr. 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.”

Dr. Harpreet Singh, Chief Scientific Officer 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. I wish to thank everyone involved in GAPVAC and look forward to the first results from this exciting collaborative effort.”