Objective
This project will develop and validate IN-3012, a novel tolerogenic vaccine that utilizes a person’s own cells to treat neutralizing antibodies (NA) in Haemophilia A patients who have failed immune tolerance induction (ITI). Haemophilia A patients are given the blood clotting protein, factor VIII as standard of care. However, a serious consequence is the development of NA towards factor VIII leading to therapy resistance. This leads to crippling arthropathy, other morbidities and high mortality. ITI is the most used treatment of this condition but 35% of patients do not respond and are in a vulnerable situation.
Haematologists and KOLs emphasise the pressing need for safe and effective technologies to overcome NA in Haemophilia A, which is not possible today. The estimated mean annual cost of a Haemophilia patient in Europe is over EUR 117,000 EUR with the mean lifetime cost reaching EUR 7.8 million. This is substantially higher in patients who have failed ITI. Therefore, while this condition has low prevalence, it exerts heavy burden on healthcare budgets and is thus a top EU health policy priority.
Idogen’s technology platform allows cells from the patient’s blood to be reprogrammed outside the body to dendritic cells with the capacity to specifically counteract adverse immune reactions. The reprogrammed cells are transferred back to the patient. IN-3012 uses this mechanism to create tolerance to factor VIII.
The research performed to date strongly supports the vaccine’s potential to eradicate NA. The proposed project will bring IN-3012 through a Phase I/II clinical trial in humans. The safety and preliminary efficacy data will constitute the basis for further clinical development and commercialisation of the product. Idogen’s strategic focus lies in establishing IN-3012 as a novel treatment in Haemophilia A patients having failed ITI. This will constitute the cornerstone of Idogen’s accelerated growth. This project is the key step to realize the strategy.
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: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- social sciences sociology demography mortality
- natural sciences biological sciences biochemistry biomolecules proteins
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
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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.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.3. - Treating and managing disease
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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.
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.
SME - SME instrument
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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.
(opens in new window) H2020-SMEInst-2016-2017
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
223 81 LUND
Sweden
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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.