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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-SC1-2016-2017

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Sub call

H2020-SC1-2016-RTD

Coordinator

KATHOLIEKE UNIVERSITEIT LEUVEN
Net EU contribution
€ 496 875,00
Address
Oude Markt 13
3000 Leuven
Belgium

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Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00

Participants (5)

GRANZER HEINZ ULRICH
Germany
Net EU contribution
€ 267 187,50
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
ISA THERAPEUTICS BV
Netherlands
Net EU contribution
€ 1 653 009,61
Address
J.h. Oortweg 19
2333 CH Leiden

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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)
Other funding
€ 0,00
EUROPEAN CANCER PATIENT COALITION
Belgium
Net EU contribution
€ 30 250,00
Address
Avenue Des Arts 6
1210 Bruxelles

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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
Other funding
€ 0,00
TTOPSTART BV
Netherlands
Net EU contribution
€ 183 875,00
Address
Laan Van Zuid Hoorn 15
2289 DC Rijswijk

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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)
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

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Region
South East (England) Hampshire and Isle of Wight North Hampshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00