Enhancing cell therapies with genomic techniques

The main goal of this opportunity is to support the development and use of innovative tools, technologies, and digital solutions to improve health outcomes. It aims to advance biomedical research, enhance therapeutic options for diseases with limited treatments, and promote the integration of advanced health technologies into healthcare systems. The focus is on engineering cells with specific therapeutic features, developing generative AI models for research, and bridging the gap between early and clinical development, with an emphasis on personalized medicine and ethical collaboration. This grant encourages partnerships across sectors and is open to entities in the United States and other eligible countries.

• Must focus on engineering human allogeneic stem or somatic cells using gene-editing and/or synthetic biology tools to enhance therapeutic functionality

• Must target only one specific therapeutic area from the provided list and clearly identify it in the proposal

• Must integrate synthetic genetic circuits (e.g. on/off switches, sense-and-respond systems) to control cell function and phenotype

• Must employ digital tools (e.g. CAD) to support design-build-test cycles for engineered cells

• Must include in-vitro and ex-vivo testing, and demonstrate function, safety, and efficacy in pre-clinical in-vivo models

• Must include interaction with regulatory authorities; feasibility for future clinical trials and qualification of the approach must be addressed

• Must account for sex-based differences in cell biology and therapeutic response

• Must include a business case and may optionally include a first-in-human study (asset, not mandatory)

• Should involve SMEs and consider synergies with relevant EU research infrastructures and prior EU-funded work

• If clinical studies are included, they must follow the required annex template in the submission system

Example Projects:

• Developing a gene-edited cell therapy for a specific form of leukemia, with pre-clinical safety studies and regulatory collaboration.
• Creating a digital health platform using generative AI to improve diagnosis and treatment planning for rare cardiovascular diseases.
• Engineering synthetic genetic circuits to enhance immune cell therapies for infectious diseases, with validation in laboratory models.

• Personnel costs
• Subcontracting
• Travel and subsistence
• Equipment (depreciation or rental)
• Consumables and materials
• Dissemination and communication
• Access to research infrastructure
• IPR and certification
• Audit costs
• Indirect costs (25% flat rate)
• Internally invoiced services

• Budget for this Call: 50,000,000€
• Number of Grants attributed: 5
• Maximum value per project: 10,000,000€
• Minimum value per project: 8,000,000€

• Applicants must be based in an eligible country as described in the official guidelines.
• Legal entities established in the United States are eligible for funding.
• Entities identified as high-risk suppliers of mobile network equipment, or those they own or control, are not eligible for certain topics.
• Applicants must meet any additional specific conditions outlined in the topic description of the Work Programme.
• Eligibility may depend on compliance with detailed requirements in the Programme Guide and topic-specific annexes.