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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 BM4, 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 bring BM4 and vitamin D3 to the start of Phase III clinical trials via the stages of GMP production, toxicity studies, and Phase I and II clinical trials. Addition of vitamin D3 will first be evaluated against placebo and a current product, followed by a safety and dose-range-finding study using BM4 and vitamin D3. BM4SIT will pave the way towards a better more attractive therapy that will improve the cost-benefit ratio compared to symptomatic drugs.

Field of science

  • /medical and health sciences/basic medicine/immunology/immunotherapy
  • /medical and health sciences/clinical medicine/allergology

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Address
Meibergdreef 15
1105AZ Amsterdam
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 643 065,87
Administrative Contact
Frank Groen (Mr.)

Participants (9)

PARIS-LODRON-UNIVERSITAT SALZBURG
Austria
EU contribution
€ 505 410
Address
Kapitelgasse 4-6
5020 Salzburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Doris Stampfer (Ms.)
HAL ALLERGY BV

Participation ended

Netherlands
EU contribution
€ 42 079,28
Address
J H Oortweg 15
2333 CH Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Coos Bos (Mr.)
BIOMAY AG
Austria
EU contribution
€ 1 205 414,25
Address
Lazarettgasse 19
1090 Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Karl Fister (Mr.)
REGION SYDDANMARK
Denmark
EU contribution
€ 404 550
Address
Damhaven 12
7100 Vejle
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Weber Strate Lars (Mr.)
RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG
Germany
EU contribution
€ 353 375,25
Address
Seminarstrasse 2
69117 Heidelberg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dieter Manthey (Dr.)
ALL-MED SPECJALISTYCZNA OPIEKA MEDYCZNA
Poland
EU contribution
€ 307 851,75
Address
Sepia 38
53 143 Wroclaw
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marek Jutel (Prof.)
TURUN YLIOPISTO
Finland
EU contribution
€ 116 205
Address
Yliopistonmaki
20014 Turku
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Mari Riipinen (Dr.)
CLINICAL TRIAL CENTER MAASTRICHT
Netherlands
EU contribution
€ 298 455,60
Address
Oxfordlaan 70
6229 EV Maastricht
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
€ 120 001
Address
113 The Murrays
EH17 8UD Edinburgh
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sangeeta Dhami (Dr.)