Objective Cervical cancer (CxCa) is caused by high risk types of the human papillomavirus (a.o. HPV16). Prophylactic HPV vaccination is not the standard of care in all European countries, and where approved it is not sufficiently adopted. Once infected, these vaccines no longer prevent premalignant lesions and CxCa, which can only be treated with surgery or radio-chemotherapy. However, this is not effective in recurrent/advanced CxCa. In underdeveloped countries, CxCa is often detected when it is too late for curative treatment. With an estimated global incidence of 500.000 new cases of CxCa and 274.000 deaths per year, the need for an effective therapy is extremely high. Targeted immunotherapy is an effective approach to induce a tumour-directed immune response. Previously, members of the IMMUNISA consortium have formulated ISA101, a cancer vaccine consisting of overlapping synthetic long peptides covering all epitopes of the HPV16 oncogenic proteins. ISA101 has shown promising Phase 1 clinical trial results in patients with advanced CxCa where it works synergistically with chemotherapy. IMMUNISA now proposes the multi-centre randomised Phase 2 CervISA-2 trial; a careful assessment of the efficacy of the proprietary ISA101b therapeutic vaccine in combination with chemotherapy for the treatment of CxCa, measured by a prolonged progression free survival. A multidisciplinary collaboration between leading clinical EU sites specialised in CxCa, a partner providing strategic and operational regulatory service and a cutting-edge biotech SME will enable the optimal implementation of the CervISA-2 trial, exploitation activities and overall project dissemination. This is pivotal to catapult further development of ISA101b as a commercial vaccine and push it towards clinical implementation as fast as possible.For ISA101b, IMMUNISA will provide, 1) clinical data on the efficacy, 2) a solid exploitation strategy and 3) the regulatory framework for efficient translation to clinical use. Fields of science medical and health sciencesclinical medicinesurgerymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccinesmedical and health sciencesbasic medicineimmunologyimmunotherapymedical and health sciencesclinical medicineoncologycervical cancermedical and health scienceshealth sciencesinfectious diseasesDNA viruses Keywords Human Papillomavirus Type16 Cervical Cancer Immunotherapy Synthetic Long Peptides Phase-2 clinical trial 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-PM-09-2016 - New therapies for chronic diseases Call for proposal H2020-SC1-2016-2017 See other projects for this call Sub call H2020-SC1-2016-RTD Funding Scheme RIA - Research and Innovation action Coordinator KATHOLIEKE UNIVERSITEIT LEUVEN Net EU contribution € 496 875,00 Address Oude markt 13 3000 Leuven Belgium See on map Region Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven Activity type 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 Participants (5) Sort alphabetically Sort by Net EU contribution Expand all Collapse all GRANZER HEINZ ULRICH Germany Net EU contribution € 267 187,50 Address See on map 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 ISA THERAPEUTICS BV Netherlands Net EU contribution € 1 653 009,61 Address J.h. oortweg 19 2333 CH Leiden 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 Zuid-Holland Agglomeratie Leiden en Bollenstreek 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 EUROPEAN CANCER PATIENT COALITION Belgium Net EU contribution € 30 250,00 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 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 TTOPSTART BV Netherlands Net EU contribution € 183 875,00 Address Laan van zuid hoorn 15 2289 DC Rijswijk 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 Zuid-Holland Agglomeratie ’s-Gravenhage 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 INC RESEARCH UK LTD United Kingdom Net EU contribution € 3 368 802,39 Address Riverview the meadows business park station approa blackwater surrey GU17 9AB Camberley See on map Region South East (England) Hampshire and Isle of Wight North Hampshire 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
