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A Next Generation Immunotherapy for Human Papilloma Virus induced Cervical Cancer

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.

Call for proposal

H2020-SC1-2016-RTD
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Funding Scheme

RIA - Research and Innovation action

Coordinator

KATHOLIEKE UNIVERSITEIT LEUVEN
Address
Oude Markt 13
3000 Leuven
Belgium
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 496 875

Participants (5)

GRANZER HEINZ ULRICH
Germany
EU contribution
€ 267 187,50
Address
Zielstattstrasse 44
81379 Munchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ISA THERAPEUTICS BV
Netherlands
EU contribution
€ 1 653 009,61
Address
J.h. Oortweg 19
2333 CH Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUROPEAN CANCER PATIENT COALITION
Belgium
EU contribution
€ 30 250
Address
Rue Montoyer 40
1000 Bruxelles
Activity type
Other
TTOPSTART BV
Netherlands
EU contribution
€ 183 875
Address
Euclideslaan 1
3584 BL Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INC RESEARCH UK LTD
United Kingdom
EU contribution
€ 3 368 802,39
Address
Riverview The Meadows Business Park Station Approa Blackwater Surrey
GU17 9AB Camberley
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)