First centres to enrol glioblastoma patients are opened in Heidelberg and Tuebingen in Germany
Immatics Biotechnologies and BioNTech are moving a novel concept of personalised therapeutic cancer vaccines into the clinic.
The German national authority, the Paul-Ehrlich-Institute (PEI), has approved the start of a phase I/II study, under the Glioma Actively Personalised VAccine Consortium (GAPVAC), which applies for the first time the concept of treating glioblastoma patients using drugs designed and manufactured for each patient individually according to specific characteristics of their tumour and immune system.
The screening of first patients for the trial has started at the University Hospital of Heidelberg, Germany, and the University Hospital of Tuebingen, Germany.
The complex manufacturing of the personalised vaccines will be performed by the GMP unit of the University of Tuebingen in co-operation 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 personalised 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 organisations in Europe and the US and is led by Immatics (Coordinator) and BioNTech (Vice Coordinator). The consortium is supported by a €6m grant from the European Union Framework 7 (EU FP7) programme.
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 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 innovative approach.
Glioblastoma patients will be immunised with two vaccines specifically prepared for each patient. The first will be a tailored selection of peptides chosen from a pre-manufactured warehouse supplied by consortium partner BCN Peptides (Barcelona) consisting of approximately 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 next-generation sequencing (NGS)-based genetic analysis of the patient and will comprise peptides manufactured by the University of Tuebingen. The latter vaccine will largely target mutations occurring in the cancer but not in healthy tissue.
Both personalised 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.
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 clinical trial is being accompanied by an extensive biomarker programme involving the Association of Cancer Immunotherapy (CIMT), a non-profit organisation dedicated to the advancement of cancer vaccines. It will be led by chief investigator Wolfgang Wick, University of Heidelberg, and co-led by Pierre-Yves Dietrich, University of Geneva, both internationally recognised experts in the treatment and immunology of brain cancer.
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.'
Harpreet Singh, Chief Scientific Officer of Immatics and Coordinator of the GAPVAC consortium, said: '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 personalised 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.'