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G2B-002

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GATE2BRAIN TOWARDS SME DESIGNATION AND PAEDIATRIC INVESTIGATIONAL PLAN

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 p... ver más

31/07/2024

GATE2BRAIN SL

75K€

Presupuesto del proyecto: 75K€

Líder del proyecto

GATE2BRAIN SL La investigacion, desarrollo tecnologico, produccion y comercializacion de sustancias, procedimientos y tratamientos con finalidad terapeuti...

TRL 4-5 | 163K€

Fecha límite participación Sin fecha límite de participación.

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2024-07-31

HORIZON-EIE-2022-SCALEUP-02-02: Women TechEU ExpectedOutcome:Project results are expected to contribute to the following expected outcomes:

Innovación

Cerrada hace 2 años

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

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1 Participantes

GATE2BRAIN SL

75.00K€ | Lider

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Duración del proyecto: 12 meses Fecha Inicio: 2023-07-20
Fecha Fin: 2024-07-31

Líder del proyecto

GATE2BRAIN SL La investigacion, desarrollo tecnologico, produccion y comercializacion de sustancias, procedimientos y tratamientos con finalidad terapeuti...

TRL 4-5 | 163K€

Presupuesto del proyecto 75K€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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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