partners
Project Coordinator
Immatics is a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer. The Company’s transformative product candidates are ‒ best in class ‒ Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics’ proprietary and world-leading XPRESIDENT® technology. XPRESIDENT® is the most sensitive, unbiased and high-throughput technology capable of identifying targets in virtually any type of cancer and any HLA type. Together with Immatics’ powerful TCR discovery technology XCEPTOR®, these two platforms allow a full range of cancer therapies to be developed. Immatics’ pipeline includes T-cell therapy programs based on the proprietary ACTolog®, ACTengine® and ACTallo® approaches, which are developed in collaboration through Immatics US with University of Texas MD Anderson Cancer Center and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT), and several bispecific TCR and antibody molecules. Operating from Tuebingen, Munich and Houston, the Company has recognized that novel, better and safer targets are the key to developing future cancer immunotherapies and it is Immatics’ mission to deliver the power of T cells to cancer patients. Immatics is acting as coordinator of this project and sponsor of the multi-center trial and is responsible for peptide identification, clinical immunomonitoring, serum biomarker studies, and sample logistics.
Vice Coordinator
BioNTech is Europe’s largest privately-held biopharmaceutical company pioneering the development of more precise and individualized therapies for cancer and the prevention of infectious diseases. The Company combines all building blocks for more precise and individualized immunotherapies under one roof – from diagnostics and drug development to manufacturing. Its cutting-edge technologies range from individualized mRNA-based product candidates through innovative chimeric antigen receptors and T-cell receptor-based compounds to novel checkpoint immunomodulators and small molecules. BioNTech’s commercial approach is validated by seven corporate partnerships with Genentech, a member of the Roche Group, Pfizer, Genmab, Eli Lilly and Company, Sanofi, Genevant and Bayer Animal Health and its scientific approach through over 60 peer-reviewed scientific publications, including five publications in Nature. Founded in 2008, BioNTech’s financial shareholders include the Struengmann Family Office as its majority shareholder, Fidelity Management & Research Company, Invus, Janus Henderson Investors, MIG Fonds, Redmile Group, Salvia and several European family office. For more information, please see: www.biontech.de.
Partners
Eberhard Karls University Tuebingen
The Department of Immunology at the Eberhard Karls University Tuebingen, led by Prof. Dr. Hans-Georg Rammensee, has been working on the vision of personalized peptide vaccination for more than a decade. Recently, the group has set up a GMP unit consisting of 6 clean air rooms for the manufacture of peptides. This was specifically designed for rapid, small-scale GMP synthesis for personalized peptide vaccination and is a core facility within this project for the synthesis of mainly mutated peptides identified via NGS and peptidomics. Additionally, the Department of Immunology of the University of Tuebingen boasts strong expertise in peptide identification and immunomonitoring.
BCN Peptides (BCN) is one of the leading companies into the cGMP manufacture of bioactive peptides for pharmaceutical and veterinary applications since 1990. BCN complies with the highest quality standards for the active pharmaceutical ingredient manufacture, and has been successfully inspected by several national and international agencies, among them the EDQM and the US FDA. Since 2008 BCN has a new fully validated multipurpose facility which has been specially designed for the production of peptides using solid phase synthesis technology. BCN is developing, manufacturing and storing all the warehouse peptides for GAPVAC. Moreover, BCN is supporting the analytical and regulatory aspects related to the peptides.
The Association for Cancer Immunotherapy (CIMT) is a non-profit organization founded in 2002. CIMT is an information and education platform for immunological cancer therapy and organizes annual scientific meetings and international collaborations. CIMT has two established working parties: the Cancer Immunoguiding Program (CIP) and the Regulatory Research Group (RRG). CIP promotes the concept of immune monitoring assay harmonization to support high-quality immune monitoring for GAPVAC. RRG has paved the way for complex actively personalized vaccines (APVACs) by establishing a feasible regulatory path for development and has ongoing discussions with experts and peers on this subject. CIMT also hosts the biggest European meeting on Cancer Immunotherapy and therefore represents the ideal platform for dissemination of results of the GAPVAC consortium to the scientific and clinical community.
University of Geneva and Geneva University Hospitals
The University of Geneva (UNIGE) enjoys worldwide recognition and ranks amongst the top 100 best universities in the world. Founded in 1559, it welcomes more than 17 000 students in its nine faculties and fourteen interdisciplinary centres and constantly strengthens its links with the International and Non-Governmental Organisations based in Geneva, one of the world’s capitals for multilateralism. A new centre for translational research in onco-hematology was recently established. The missions of the Geneva University Hospitals (HUG) include providing health care to the community in all medical specialties, contributing to training physicians and health professionals, and conducting clinical research as well as finding treatments. The HUG operate as a national reference centre for influenza and emerging viral infections, as well as for liver disease in children and paediatric liver transplant. They are a WHO Collaborating Centre in seven areas. In 2017, with their 11,560 staff, the HUG treated 63,000 inpatients, 118,000 emergencies, and more than a million outpatients, and performed 27,041 surgeries and 4,182 birth deliveries. They collaborate closely with the Faculty of Medicine of the University of Geneva, the WHO, CHUV, EPFL, CERN and other actors in the Lemanic Health Valley on a number of training and research projects. More information on: unige.ch and regarding Activity Report, Key Figures, and Strategic Plan: http://www.hug-ge.ch/publications-hug. Press contact: presse-hug@hcuge.ch
In the Laboratory of Tumour Immunology (created in 1994), the Geneva group has studied human glioma, with parallel investigations in mouse models. Molecular and cellular parameters of the immune infiltrate in human glioma have been characterised, and immunosuppressive mechanisms have been defined. In vivo functional studies in the mouse have defined key mechanisms controlling T cell tropism for brain tumours. More recently, in collaboration with industrial and academic partners, the group contributed to the identification of several novel glioma associated antigens and validated the choice of 10 selected glioma antigens by characterizing their immunogenicity in glioma patients, and showing spontaneous responses in glioma infiltrating lymphocytes. Prof. Pierre-Yves Dietrich co-leads the GAPVAC phase I clinical trial.
University Hospital Heidelberg
Neurooncology is a prototypical interdisciplinary part of neurological and oncological sciences. The Department of Neurooncology in Heidelberg is the first organ-specific discipline recruited to the National Center for Tumor Diseases Heidelberg in 2007. It comprises efforts in neurology, neurosurgery, radiation oncology, and oncology, further the diagnostic disciplines neuroradiology, neuropathology and nuclear medicine as well as the related research groups both in the clinic and the German Cancer Research Center. More than 20 research groups in the program have a focus on brain tumors.
Heidelberg is the largest and most active brain tumor center in Europe, currently actively pursuing 20 phase I-III multicenter clinical trials, many of which are investigator initiated trials with coordinating function. The research focus is on molecularly-guided precision medicine, overcoming resistance to classical radiochemotherapy and academic development of biomarkers and immunotherapy. Wolfgang Wick is the lead-investigator for the GAPVAC trial.
Center for Cancer Immune Therapy (CCIT), Herlev Hospital, Department of Haematology, at Herlev Hospital is the leading center in Denmark with a focus on tumor immunology and immunotherapy. CCIT is a research center focused on development and testing of immunological treatment of cancer. CCIT has a research profile based on equally weighted experimental and clinical projects. CCIT has extensive experience in characterization of tumor antigens recognized by CD8+ T cells, studies of T cell and DC biology, and biological monitoring of vaccination trials. Ongoing clinical activities include vaccination trials in non-small cell lung cancer, melanoma and breast cancer. Also, adoptive cell transfer clinical trials based on the use of tumor infiltrating lymphocytes (TIL) are ongoing.
The Department of Radiation Biology (www.radiationbiology.dk) and the Section for Neuro-oncology at the Department of Oncology, The Finsen Centre situated at Copenhagen University Hospital, Denmark are focused on translational and clinical research with in the field of neuro-oncology. The pre-clinical research performed at the Department of Radiation Biology is focused on finding novel targets involved in the development or treatment of glioblastoma multiforme (GBM). In this relation the Department of Radiation Biology is closely connected to the Section for Neuro-Oncology at the Department of Oncology which also houses the Phase I Unit where all phase I/II clinical trials are performed. The expertise at the Section for Neuro-oncology is treatment of adult patients with primary brain tumors and each year, 140 newly diagnosed patients with GBM are treated here. Treatment of GBM patients occur at the Section for Neuro-Oncology in collaboration with the Phase I Unit where new clinical up-front phase I and II protocols are provided. In addition, the Department of Radiation Biology houses a clinical database and through a close collaboration with the Department of Neurosurgery and the Department of Neuropathology it is possible to gain access to both clinical data and tumor tissue from GBM patients treated at Copenhagen University Hospital. Finally, our department is member of a research consortium including The Biotech Research and Innovation Centre, Copenhagen University (www.bric.ku.dk), NorLUX Luxembourg and Bergen University (www.norlux.lu).
Leiden University Medical Centre
LUMC is one of the eight medical centers in the Netherlands. More than 7000 staff members of the LUMC are passionate about improving patient care through scientific research. The LUMC focuses on top clinical and highly specialized care: the complex medical issues for which there are often not yet any answers. With patient care and research labs under one roof, patients, doctors and researchers collaborate to develop new treatment methods. Patient care is largely focused on highly specialized care, the sort of care that cannot be provided anywhere else. The research conducted in the LUMC is both fundamental and patient- and care-oriented. A considerable portion of the research centers on the translation from fundamental research to its use in patient care (from bench to bedside and vice versa).
University of California San Francisco (UCSF)
School of Medicine and the Brain Tumor Research Center (BTRC)
UC San Francisco is the nation’s leading university exclusively focused on health. Now celebrating the 150th anniversary of its founding as a medical college, UCSF is driven by the idea that when the best research, the best education and the best patient care converge, great breakthroughs are achieved.
The birthplace of biotechnology, UCSF’s faculty includes five Nobel laureates who have made seminal contributions to advancing the understanding of cancer, neurodegenerative diseases, aging and stem cell research. All four UCSF professional schools — Dentistry, Medicine, Nursing and Pharmacy — as well as virtually all UCSF graduate programs, UCSF Medical Center and UCSF Benioff Children’s Hospital San Francisco, consistently rank among the best in the nation, according to the latest surveys by US News & World Report. The graduate-level university also leads the nation in biomedical research and is the top public recipient of highly competitive research funding from the National Institutes of Health. Together, this research, education and patient care contribute to UCSF’s public mission of advancing health worldwide.
Prof. Dr. Christian Ottensmeier, Medical Oncologist and Director of Experimental Cancer Medicine Centre has a long standing interest in translational immunotherapy with his own substantial clinical trials portfolio of vaccines and immunostimulatory antibodies in early phase clinical studies in both solid tumours and hematological malignancies. His group has developed nationally leading expertise in evaluating immunotherapeutic vaccines by developing and validating immunological biomarkers to GCLP. Clinically he coordinates a broad clinical trials portfolio in the tertiary referral centre for a population of approx. 3.000.000 along the south coast of the UK. Specific local expertise includes dedicated neurosurgery (Dr. Paul Grundy) and neurooncology (Dr. Omar Al Salihi). The team also participates in the independent IMA950 glioma study.
Technion – Israel Institute of Technology
Technion Research Group has been involved with the analysis of HLA peptidomes by mass spectrometry for about 15 years. It advanced the approach of analyzing the soluble HLA (sHLA) peptidomes of cultured human cancer cells by transfecting into the cells the genes encoding different HLA alleles in a form that makes their protein products released from the cells in a soluble form while carrying their authentic pools of peptides. More recently, Prof. Arie Admon and Dr. Michal Bassani-Sternberg have invented the idea of analyzing the repertoires of peptides carried by the sHLA molecules naturally released from the tumor cells into the patient’s plasma and use these identified and quantified sHLA peptidomes as a source for biomarkers and tumor antigens. Technion is responsible for the sHLA peptidome and proteomics program within GAPVAC.
Vall d´Hebron University Hospital
Vall d’Hebron University Hospital (HUVH) is one of the largest hospitals in Spain. HUVH acts as a clinical center in the consortium that provides an interdisciplinary approach to the treatment of adults and children with brain tumors. The departments of oncology, radiotherapy, neuroradiology, neuropathology, and neurosurgery at the HUVH have an established neuro-oncology program providing leading-edge, integrated treatment for patients with tumors of the brain and central nervous system. Translational research in neuro-oncology is embedded in a multi-disciplinary program with a strong focus on early drug development in malignant primary brain tumors, especially glioblastomas. All physicians involved in the neuro-oncology program are committed to carrying out research. This ensures that the latest and most effective imaging techniques, surgical techniques, and management strategies are available to each patient. Our neuro-oncology program includes a Brain Tumor Committee that meets every week to discuss and review complex cases and determines the optimal method of treatment for each individual patient (www.neuroncology.org).