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AN INNOVATIVE CAUSAL THERAPY FOR ALLERGY: SAFE AND RAPID INDUCTION OF AN ANTI-INFLAMMATORY IMMUNE RESPONSE USING A MUTANT HYPOALLERGEN AND VITAMIN D3

Objective

Allergy is the most prevalent chronic inflammatory disease, having great socio-economic impact. Chronic lifelong dependency on symptomatic drugs is an expensive reality for the vast majority of allergy sufferers. Allergen-specific immunotherapy is the only causal and effective treatment targeting the underlying immune mechanism in a more cost-effective way. Yet, long treatment duration and risk of anaphylactic side-effects have prevented this treatment from becoming the first choice. BM4SIT aims at providing an escape from its current niche position by making the treatment safer, more effective and patient friendlier, i.e. developing a therapy
with negligible side-effects but improved efficacy, achieved by less injections. The concept of BM4SIT is based on two innovations: replacing current natural allergen extracts by mutated recombinant allergens having been designed to be hypo-allergenic but hyper-immunogenic, and adding an adjuvant to support rapid and effective induction of an anti-inflammatory immune response. The allergen derivative chosen to bring this concept from bench to bedside is BM41, a mutant of the culprit allergen of birch pollen allergy, Bet v 1. Pre-clinical data have demonstrated strongly reduced allergenicity, significantly increased immunogenicity and efficacy in a mouse model for birch pollen allergy. The selected adjuvant is vitamin D3, which has been shown to promote active suppression of inflammation, both in vitro and in a mouse model. The product-focused, IP-protected consortium of BM4SIT will test the immunological and clinical added value of vitamin D3in combination with a current product in a randomized DBPC trial. First-in-man safety of BM41 will be evaluated against placebo, using a current product as comparator. Preliminary efficacy data will be obtained using surrogate in vitro serological and cellular tests.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
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Coordinator

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Address
Meibergdreef 15
1105AZ Amsterdam
Netherlands

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank Groen (Mr.)
EU contribution
€ 3 065 458

Participants (9)

PARIS-LODRON-UNIVERSITAT SALZBURG
Austria
EU contribution
€ 515 800
Address
Kapitelgasse 4-6
5020 Salzburg

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Doris Stampfer (Ms.)
HAL ALLERGY BV

Participation ended

Netherlands
EU contribution
€ 46 500
Address
J H Oortweg 15
2333 CH Leiden

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Coos Bos (Mr.)
BIOMAY AG
Austria
EU contribution
€ 1 302 750
Address
Lazarettgasse 19
1090 Wien

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Karl Fister (Mr.)
ODENSE UNIVERSITETSHOSPITAL
Denmark
EU contribution
€ 452 400
Address
Sdr. Boulevard 29
5000 Odense

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Activity type
Research Organisations
Administrative Contact
Weber Strate Lars (Mr.)
RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG
Germany
EU contribution
€ 118 500
Address
Seminarstrasse 2
69117 Heidelberg

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dieter Manthey (Dr.)
ALL-MED SPECJALISTYCZNA OPIEKA MEDYCZNA
Poland
EU contribution
€ 55 500
Address
Sepia 38
53 143 Wroclaw

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marek Jutel (Prof.)
TURUN YLIOPISTO
Finland
EU contribution
€ 287 700
Address
Yliopistonmaki
20014 Turku

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Mari Riipinen (Dr.)
CLINICAL TRIAL CENTER MAASTRICHT

Participation ended

Netherlands
EU contribution
€ 30 600
Address
Oxfordlaan 70
6229 EV Maastricht

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Carl De Bont (Mr.)
EVIDENCE-BASED HEALTH CARE LTD
United Kingdom
EU contribution
€ 121 200
Address
113 The Murrays
EH17 8UD Edinburgh

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sangeeta Dhami (Dr.)