Project description DEENESFRITPL New vaccine for HPV16-positive cancer tested The EU-funded TIGER project will demonstrate the benefits of a novel mRNA cancer vaccine platform optimised for intravenous administration into patients. The antigens that will be used to deliver proof of principle comprise mRNAs encoding the proteins E6 and E7 of the human papillomavirus strain 16 (HPV16) and TriMix mRNAs that act as an adjuvant to stimulate dendritic cells to initiate strong T-cell responses. The study will be in patients with recurrent HPV16-positive cancer without and with a PD-1 checkpoint inhibitor. Safety, immunogenicity and clinical benefit will be key endpoints for this study. Once validated, the platform will be readily translatable to a wide range of cancers using other tumour antigens. Show the project objective Hide the project objective Objective TIGER delivers proof of principle (PoP) in humans for a novel best-in-class therapeutic mRNA cancer vaccine platform optimized for intravenous (IV) administration, with the aim to show clinical benefit. The antigens used for the PoP consists of mRNAs encoding the proteins E6 and E7 of Human Papilloma Virus strain 16 (HPV16), and TriMix mRNAs that act as adjuvant to stimulate dendritic cells to start strong T cell responses. The mRNAs will be formulated in a novel patented lipid nanoparticle shielding the mRNA, and delivering it to immunoactive antigen presenting cells, vastly enhancing T-cell response. Safety and potent efficacy of our IV mRNA product have been demonstrated in rodent experiments. Furthermore, preclinical to clinical translation has been shown for our TriMix based vaccines using different delivery strategies. Based on the preclinical and prior clinical data, our platform has the potential to cure cancer patients.The PoP study will be in patients with recurrent HPV16 positive cancer, which is categorised as a non-communicable disease by the WHO, without and with a PD-1 checkpoint inhibitor. Safety, immunogenicity and clinical benefit will be key endpoints of the study. Biomarker and PROM research will allow future informed therapeutic and care decisions by both patient and care team. Recruitment and stratification plans will be in place. Interactions with regulatory, reimbursement and ethical authorities together with patients and carers will help laying out the route to the patient not only for our product but also for all other mRNA cancer vaccines. The project encompasses essential elements for preparing therapy validation in later stage clinical studies, while addressing patient needs, values and choices. Upscaling of GMP-production for IV mRNA vaccines will enable further clinical studies. Once validated, our platform will be easily translatable to a wide range of cancers using other tumour antigens, be they TSA, TAA or neoantigens. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesclinical medicineoncology Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-BHC-08-2020 - New interventions for Non-Communicable Diseases Call for proposal H2020-SC1-BHC-2018-2020 See other projects for this call Sub call H2020-SC1-2020-Two-Stage-RTD Funding Scheme RIA - Research and Innovation action Coordinator ETHERNA IMMUNOTHERAPIES Net EU contribution € 5 094 401,25 Address Galileilaan 19 2845 Niel Belgium See on map Region Vlaams Gewest Prov. Antwerpen Arr. Antwerpen Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 12 421 045,75 Participants (7) Sort alphabetically Sort by Net EU contribution Expand all Collapse all SAGA DIAGNOSTICS AB Sweden Net EU contribution € 186 187,50 Address Scheelevagen 2, mv-401 223 81 Lund See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Södra Sverige Sydsverige Skåne län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STICHTING VUMC Netherlands Net EU contribution € 241 226,25 Address De boelelaan 1117 1081 HV Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 CLINIQUE UNIVERSITAIRE SAINT-LUC ASBL Belgium Net EU contribution € 311 435,00 Address Avenue hippocrate 10 1200 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EUROPEAN CANCER PATIENT COALITION Belgium Net EU contribution € 223 125,00 Address Avenue des arts 6 1210 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ONCORADIOMICS Belgium Net EU contribution € 400 000,00 Address Boulevard patience et beaujonc 3 4000 Liege See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Région wallonne Prov. Liège Arr. Liège Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 CERATIUM BV Netherlands Net EU contribution € 221 812,50 Address Veemkade 240 1019 HD Amsterdam See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 PATERGRUS BVBA Belgium Net EU contribution € 221 812,50 Address Sparhoekdreef 57 9880 Aalter See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Vlaams Gewest Prov. Oost-Vlaanderen Arr. Gent Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00
