OFFICIAL INFORMATION

Horizon Health Call: Development of Next Generation Advanced Therapies

On this page we share all available information on the Horizon Europe Health ‘HLTH-2021-Tool-06-02’ (Call that has been announced from the Health cluster. This cluster falls under Pillar 2 of Horizon Europe: Global Challenges and European Industrial Competitiveness. 

What is the HLTH-2021-Tool-06-02 Call?

This call is for ‘Next generation advanced therapies to treat highly prevalent and high burden diseases with unmet needs’.

General information:

  • Project type: Research & Innovation Actions (RIA)
  • Subsidy:         €6M
  • Funding rate: 100%
  • Deadline:       21 September 2021
  • Duration:        No limit, up to 4 years is recommended
  • Total budget: €60M
  • Consortium: At least 3 legal entities in 3 different Member States or Associated Countries.

Scope of the Horizon Europe Health call:

The recent development of advanced therapies has been hampered by the lack of robust research on certain key parameters e.g. safety, upscaling, immunity, potency assays, cost-effectiveness, and early on in development. This topic aims to ensure that the next wave of advanced therapies, based on either pluripotent stem cells, gene editing or RNA, are established in a timely fashion and in accordance with the appropriate regulatory standards for further clinical testing.

It will support preclinical research platforms for disorders with high prevalence and burden1 that tackle the following bottlenecks currently encountered in the field, ensuring that promising advanced therapies can reach the market within the next decade. Applicants should justify the disorder chosen to be targeted with its level of prevalence, the related burden and unmet needs. Applicants should propose activities in one or several of the following areas, taking into consideration the Oviedo Convention, eligible actions and ethical principles as defined by the regulation:

  • Method development for the production and differentiation of pluripotent stem cells2 (defined as cells that can give rise to cells from all three embryonic germ layers), to include defining appropriate potency assays. Complementary activities to assess mode of action, safety, in vivo validation or upscaling procedures could be considered.
  • Development and validation of biological assays and methods that can demonstrate efficacy, delivery, specificity, and safety (including off-target effects) of genome editing products in targeted cells and tissues (e.g. base editing, prime editing, transcription activator-like effector nucleases, zinc-finger nucleases, clustered regularly interspaced short palindromic repeats). Complementary activities to assess in vivo validation or upscaling procedures could be considered.
  • Development and validation of novel RNA-based therapeutics targeting noncommunicable diseases. Complementary activities to assess mode of action, delivery, safety in vivo validation and/or upscaling procedures could be considered.
  • Study, analysis and tackling of different immune responses, taking into account factors like sex and age, generated by any of the above-mentioned advanced therapies in vivo, facilitating regulatory approval for next phase of research and development.

Expected outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of EU Health Cluster’s destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored and contributing to all of the following expected outcomes:

  • Competent authorities, researchers and developers have at their disposal assays for the valorisation and/or assessment of efficiency, delivery, safety, potency or mode of action of novel advanced therapeutic interventions based on either pluripotent stem cells, genome editing or RNA, that are aligned with regulatory standards.
  • Clinicians, researchers and developers test several new advanced therapies based on pluripotent stem cells, gene editing or RNA ready through clinical trials meeting the regulatory requirements.

 

[1] As defined by www.who.int/medicines/areas/priority_medicines/en/
[2] Definition: Embryonic stem cells and induced pluripotent stem cells are pluripotent stem cells.
www.nature.com/subjects/pluripotent-stem-cells


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