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GATE2BRAIN TOWARDS SME DESIGNATION AND PAEDIATRIC INVESTIGATIONAL PLAN

Project description

Breaking barriers to treat paediatric brain tumours

Paediatric brain tumours, particularly diffuse intrinsic pontine glioma (DIPG) and glioblastoma, stand as formidable adversaries with no current cure and dismal prognoses. The blood-brain barrier adds an extra layer of complexity, hindering effective therapeutic interventions in the brain. In response, the EU-funded G2B-002 project is supporting Spain-based Gate2Brain in spearheading a transformative initiative; it will leverage a pioneering peptide-based technology to breach biological barriers and revolutionise treatments for these devastating paediatric diseases and other central nervous system diseases in the future. The project aims to catalyse breakthroughs, offering newfound hope in the fight against these rare yet lethal afflictions.

Objective

Gate2Brain (G2B) is a biotech company focused on the development of therapeutics that efficiently cross biological barriers such as the blood-brain barrier (BBB). Using this radically innovative peptide-based patented technology platform, G2B has developed a novel therapy, G2B-002, for pediatric brain tumors such as Diffuse Intrinsic Pontine Glioma (DIPG) and Glioblastoma, currently without a cure or poor prognosis.
Small and medium-size enterprises (SMEs) represent 99% of all business in the EU. G2B will apply to obtain SME designation to have access to finance and EU support programs which include research, competitiveness, and innovation funding. Another potential benefit that G2B could obtain is the fewer requirements or reduced fees for EU administrative compliance. G2B is mainly focused on pediatric brain cancer, a rare but mostly lethal Central Nervous System disease. After obtaining SME designation, G2B will develop the Paediatric Investigational Plan (PIP) included in the EU Paediatric Regulation. Thus, G2B expects also to benefit from: (i) reduction of registration taxes; (ii) tax deductions; (iii) access to financial support; (iv) assistance in the drafting of clinical trial protocols; (v) ease of access to procedures to accelerate marketing in Europe; (vi) right to marketing exclusivity for 10 years in Europe; and (vii) 6-month extension patent protection initiative of medicines for children.
The Health Economics & Market Access Outcomes Strategy that G2B will also perform will include a willingness-to-pay and product-market fit analysis, between others. The final report will help to estimate the economic value of the company considering relevant alternatives for both the healthcare system and pharmaceutical industry.
The R&D strategy of G2B is focused on the therapeutic validation of its Platform to demonstrate its safety and efficacy. With SME designation and PIP, G2B will be able to successfully initiate first in human clinical trials in pediatric population.

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-CSA - HORIZON Coordination and Support Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-EIE-2022-SCALEUP-02

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Coordinator

GATE2BRAIN SL
Net EU contribution

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.

€ 75 000,00
Address
CALLE BALDIRI I REIXAC 4-8
08028 Barcelona
Spain

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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
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

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.

No data
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