EU-funded consortium led by Immatics and BioNTech announces completion of regular study treatment in the GAPVAC-101 trial

Study is assessing fully personalized therapeutic cancer vaccines for patients with brain cancer

 Tuebingen/ Mainz, March 24, 2017 – Immatics Biotechnologies GmbH and BioNTech AG announce today the completion of regular study treatment in the GAPVAC-101 clinical trial. The phase 1/2 trial assesses for the first time therapeutic cancer vaccines designed and manufactured for each glioblastoma patient individually based on the specific characteristics of their tumor and immune system.

The clinical trial is being 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.

The Glioma Actively Personalized VAccine Consortium (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 13 organizations in Europe and the United States and is led by Immatics Biotechnologies GmbH (coordinator) and BioNTech AG (vice coordinator).

Until completion of patient recruitment in July 2016, the phase 1/2 clinical trial has recruited 16 newly diagnosed glioblastoma patients. To-date the trial has shown that the consortium’s highly personalized, complex multi-peptide APVACs can be designed and manufactured within the European regulatory environment and within acceptable time lines for physicians and patients. Moreover, APVACs are well tolerated and show an acceptable safety profile. Results from the trial including immune data analysis are expected in the second half of 2017. Some patients are still continuing APVAC vaccinations beyond the last regular study visit under the discretion of their treating physicians to fully exploit the potential benefit from the APVACs specifically tailored to their disease.

Prof. Dr. Wolfgang Wick, Chair of the Neurology Clinic at the University of Heidelberg, said: “I’m excited to announce that we have completed regular study treatment in the GAPVAC-101 trial. I am pleased to report that we have successfully managed the highly complex process of sample collection, analysis, vaccine design and manufacturing. This enabled us to offer personalized APVACs to all patients in the study, showing that a truly personalized vaccine approach is feasible. We believe that it provides a blueprint for future trials in personalized medicine. Congratulations to the Consortium for the achievements.”

Dr. Carsten Reinhardt, Chief Medical Officer of Immatics, said: “This is a key milestone for the GAPVAC consortium as we look to assess the potential of biomarker-guided personalized vaccines to deliver improved outcomes for patients with glioblastoma. We look forward to having a full picture of the data later in 2017.”

Prof. Dr. Ugur Sahin, Chief Executive Officer of BioNTech AG and Vice Coordinator of the GAPVAC consortium, said: “The GAPVAC consortium used individual tumor mutations in glioblastoma as targets for cancer immunotherapy. With the GAPVAC clinical trial, the consortium proved that this approach of truly individualized treatments is feasible and furthermore promising to significantly extent the treatment options for cancer patients.”

 GAPVAC announcement: Completion of regular study treatment