HORIZON EUROPE
Europeo
Specific Challenge:To improve therapy, the understanding of the tumour microenvironment needs to evolve. Firstly, the understanding of tumour/host interaction on the cellular and molecular level in the absence of therapeutic intervention needs to improve. Both individual tumours and individual hosts are heterogeneous with respect to the quality and degree of immunity. Understanding the cellular and molecular nature of the tumour microenvironment will (i) help us characterise the ability of a patient’s immune system to mount an anti-tumour attack and (ii) provide ideas which pharmacological interventions may support or activate the immune cells to attack the tumour cells.
Secondly and in close alignment with the previous paragraph, one needs to understand how current therapeutic approaches affect the host/tumour interaction to have a baseline from which to improve the current therapeutic paradigm. Such data could be used to further improve currently available treatments or to develop new potential therapeutic strategies.
The proposed topic, for the first time, will assemble a consortium to generate a data set sufficient to gain a meaningful view of the tum...
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Specific Challenge:To improve therapy, the understanding of the tumour microenvironment needs to evolve. Firstly, the understanding of tumour/host interaction on the cellular and molecular level in the absence of therapeutic intervention needs to improve. Both individual tumours and individual hosts are heterogeneous with respect to the quality and degree of immunity. Understanding the cellular and molecular nature of the tumour microenvironment will (i) help us characterise the ability of a patient’s immune system to mount an anti-tumour attack and (ii) provide ideas which pharmacological interventions may support or activate the immune cells to attack the tumour cells.
Secondly and in close alignment with the previous paragraph, one needs to understand how current therapeutic approaches affect the host/tumour interaction to have a baseline from which to improve the current therapeutic paradigm. Such data could be used to further improve currently available treatments or to develop new potential therapeutic strategies.
The proposed topic, for the first time, will assemble a consortium to generate a data set sufficient to gain a meaningful view of the tumour micro-environment. The generation of such a data set is the core activity of this IMI2 JU topic while the future purposes (improvement of the currently available treatments and development of potential therapeutic strategies) go beyond the frame of this topic.
Scope:The ultimate aim and core activity is to create a database containing integrated cellular and molecular data from the tumour microenvironment of patients treated with both targeted and non-targeted therapy, in particular immunotherapy, as well as key information from patient history and clinical progression.
Core activity (broad profiling):
development of a fully integrated data set of defined immune cell subsets (deliverables (1) and (2)) in samples from patients from specific cancer indications treated with radiotherapy, chemotherapy, targeted therapy and, in particular, targeted immune checkpoint therapy and correlation to the oncogenomic profile of the tumour.
Supplemental activities:
in-depth profiling of a subset of samples from patients undergoing immunotherapy using selected advanced technologies;development of a sustainable open-access, royalty-free and precompetitive database that houses such a data set, including the required privacy settings;generation of a biomarker validation platform to identify and start to characterise potential predictive biomarkers for single-agent and combinatorial immunotherapy trials.
Expected Impact:A comprehensive database, profiling immune cells in the tumour microenvironment (TME) of patients that are responsive to immune checkpoint blockade versus those that are not, is generally lacking at the present time and therefore the creation of such a database is the ultimate aim of this IMI2 JU topic. A searchable database, with integrated tumour genomic information along with matched immune profiles and (immune) therapy outcome, will enable users to identify biological networks involved in, and develop biomarkers to predict response to, immunotherapy. Maximum impact would be achieved by continued integration of clinical outcome data received after the end of the consortium. This IMI2 JU topic is expected to be the basis for future significant impacts but these will go beyond the scope and timeframe of the IMI2 JU topic:
identification of novel predictive biomarkers and patient selection strategies and thereby improving clinical response rate to current cancer immunotherapy and other therapeutic regimens in oncology; such discoveries and improvements should enhance clinical and healthcare practice; understanding mechanism(s) of resistance to current immunotherapy, but also other therapy regimens, to enable identification of new therapeutic targets;establishing rational combination immunotherapy strategy (this should strengthen competitiveness and help to address the specific societal challenge of low response rates in cancer patients to current therapies);deriving therapy solutions for patients that are insensitive to immune checkpoint blockade (thus generating a positive impact on European cancer patients’ health and wellbeing in the long-term);understanding molecular effects and potential safety liability of immunotherapy.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
The IMI2 13th Call for proposals topic text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Condtions section, as well as the following information:
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full p... Please read carefully all provisions below before the preparation of your application.
The IMI2 13th Call for proposals topic text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Condtions section, as well as the following information:
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA), clinical trials template:
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Proposal templates are available after entering the submission tool.
Standard evaluation form RIA
IMI2 Model Grant Agreement:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !
IMI2 Coordination and Support Action (IMI2-CSA):
Proposal templates are available after entering the submission tool.
Standard evaluation form CSA
IMI2 Model Grant Agreement:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 - 2nd Amendment to the Annual Work Plan 2017
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
Información adicional de la convocatoria
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