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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
- medical and health sciences health sciences inflammatory diseases
- medical and health sciences clinical medicine allergology
- medical and health sciences basic medicine immunology immunotherapy
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
FP7-HEALTH-2013-INNOVATION-1
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Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
1105AZ Amsterdam
Netherlands
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.