Advancing cell secretome-based therapies

The grant opportunity titled "Advancing cell secretome-based therapies" is part of the Horizon Europe program under the Health Cluster. This grant focuses on developing innovative therapies based on components from cell secretomes, targeting the areas of health-related biotechnology and regenerative medicine. Eligible applicant types include universities, research institutes, small and medium-sized enterprises (SMEs), biopharmaceutical developers, and healthcare providers. Collaborative partnerships are encouraged, and the presence of public-private partnerships is noted.

The funding type is a grant classified under HORIZON Research and Innovation Action (RIA), which typically covers 100% of eligible costs. A consortium is required for submission, generally needing partners from multiple EU or associated countries. Geographic eligibility extends to EU member states, EEA countries, and associated nations, including the United States.

The projects are anticipated to be in the development and validation stages, addressing the bottlenecks in secretome-based therapies, including mechanism of action, reproducibility, and quality assurance. The funding amount ranges from €8 million to €10 million per project, with a total budget of €50 million anticipated for five projects. The application process is single-stage, with a deadline set for September 16, 2025.

The grants aim to foster collaboration among researchers and clinicians, enhance manufacturing processes for innovative health technologies, and ensure that patients have access to new therapies. Funding specifics allow for extensive studies addressing regulatory compliance, ethical standards, and the establishment of standardized manufacturing protocols.

The call emphasizes the importance of addressing health issues with significant public impact and encourages the consideration of sex differences in applications. There is no explicit co-funding requirement. The success rates for applications are estimated between 10% and 39%, reflecting typical competition levels for Horizon Europe funding.

In conclusion, this grant seeks to advance the field of cell secretome-based therapies, promoting cross-border collaborations and innovative solutions for healthcare challenges while aligning with the European Union’s strategic health priorities. The opportunity is a strategic move aimed at bridging research with practical healthcare applications, ultimately aiming to improve health outcomes for patients across European regions.

This is a Horizon Europe grant opportunity focused on advancing cell secretome-based therapies, specifically under the HORIZON-HLTH-2025-01-TOOL-02 topic. The call falls under Cluster 1 Health and is a single-stage process with a deadline of September 16, 2025. The opening date is May 22, 2025. It is a HORIZON Research and Innovation Action (RIA) with a HORIZON Action Grant Budget-Based [HORIZON-AG] model grant agreement. The budget is 40,000,000 EUR, with contributions ranging from 9,000,000 to 13,000,000 EUR and an indicative number of 3 grants.

The primary aim is to support activities that contribute to the destination of "Developing and using new tools, technologies and digital solutions for a healthy society." The expected outcomes include fostering collaboration between researchers, biopharmaceutical developers, and clinicians, promoting standardized manufacturing processes for innovative health technologies, and providing healthcare providers and patients with access to new therapies that offer demonstrated health benefits. Ultimately, the goal is to improve patient outcomes and enhance health systems.

The scope of the projects should address the bottlenecks in secretome-based therapies, such as incomplete understanding of their mode of action, lack of reproducibility due to non-standardized manufacturing, and insufficient potency and quality assurance assays. Projects should cover secretomes or their parts derived from human cells, including:

Selection of a secretome-based therapy with a well-understood mechanism of action in in-vitro and/or in-vivo models.
Characterization of the selected secretome or its bioactive components (extracellular vesicles, trophic factors, organelles, RNA, proteins, peptides, etc.), including potentially harmful ones, with demonstrated therapeutic activity in relevant pre-clinical models.
Activities to ensure regulatory and ethical approvals for clinical studies, including full characterization, standardized analytical methods, further pre-clinical studies, and quality assurance assays (computational approaches, organoids, organ-on-chips/microfluidic systems).
Establishment of a manufacturing protocol for the secretome or its components, covering parent cell selection, pre-conditioning, bio-processing (isolation, expansion, cultivation in bioreactors), processing of conditioned media, extraction of secretome components (isolation, purification, storage, distribution), and delivery to the target site (mode of administration, final formulation).
Definition of relevant quality criteria and establishment of a fully GMP-conform production process for clinical trials.
Interaction with competent authorities to comply with requirements for clinical trials.
Conduct of an interventional randomised controlled clinical trial comprising phase 1 and phase 2 to generate scientific evidence demonstrating safety and efficacy.
Delivery of documentation for GMP-conform production (e.g., SOPs) by month 12 and documentation for clinical trial conduct (e.g., IMDP) by month 24.
Performance and finalization of phase 1 and phase 2 clinical trials during the project's lifetime, aiming for authorization of the proposed secretome-based therapy.
Optional engineering of the secretome to improve safety and therapeutic effect, modifying it pre- or post-biogenesis using classical methods on parent cells (excluding genetic modification) or physico-chemical modification of bioactive components, while maintaining the therapy within the boundaries of substances of human origin.

The call encourages targeting diseases affecting larger patient populations or those posing a high burden on public health systems. Sex differences should be considered in both parent cells and therapeutic applications. Strong encouragement is given to the participation of SMEs, with a commitment to first deployment in the EU if an exploitation strategy is developed. Involvement of the European Commission's Joint Research Centre (JRC) is encouraged for potential collaboration in pre-normative regulatory science and validation of test methods. Applicants are required to provide details of their clinical studies in a dedicated annex.

The admissibility conditions, proposal page limits, eligible countries, financial and operational capacity, evaluation and award criteria, submission and evaluation processes, indicative timeline, and legal and financial setup are detailed in the Horizon Europe Work Programme General Annexes.

Application and evaluation form templates, guidance documents, model grant agreements, call-specific instructions, and additional documents are available in the Submission System and through provided links. Partner search announcements can be viewed and edited on the Funding & Tenders Portal.

In summary, this Horizon Europe call aims to foster the development and clinical translation of safe and effective secretome-based therapies. It encourages collaborative projects that address key challenges in manufacturing, characterization, and clinical validation, ultimately leading to improved healthcare solutions and patient outcomes. The call emphasizes regulatory compliance, involvement of SMEs, and consideration of sex differences in therapeutic applications. This opportunity seeks to bridge the gap between promising research and tangible benefits for patients and healthcare systems in Europe.

Eligible Applicant Types: The eligible applicant types include researchers, biopharmaceutical developers, clinicians, producers of innovative health technologies, healthcare providers, SMEs (Small and Medium-sized Enterprises), and legal entities established in the United States of America. The Joint Research Centre (JRC) may also participate as a member of the consortium.

Funding Type: The funding type is primarily a grant, specifically a HORIZON Research and Innovation Action (RIA) and HORIZON Innovation Action (IA) under the Horizon Europe program. There are also Coordination and Support Actions (CSA). The MGA (Model Grant Agreement) type is HORIZON Action Grant Budget-Based [HORIZON-AG].

Consortium Requirement: The opportunity appears to favor a consortium approach, as it involves researchers, biopharmaceutical developers, clinicians, producers of innovative health technologies, and SMEs. The Joint Research Centre (JRC) may participate as a member of the consortium.

Beneficiary Scope (Geographic Eligibility): Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. Any legal entity established in the United States of America is eligible to receive Union funding.

Target Sector: The target sector is health, specifically focusing on the development and advancement of cell secretome-based therapies. This includes regenerative medicine, biopharmaceutical development, and innovative health technologies. The program targets all types of diseases, dysfunctions, or health impairments, with a preference for conditions affecting larger patient populations or representing a high burden on public health systems.

Mentioned Countries: United States of America, EU member states and associated countries.

Project Stage: The project stage is focused on development, validation, and demonstration, with an emphasis on translating innovative therapeutic approaches into healthcare solutions. The projects should cover activities necessary to ensure regulatory and ethical approvals, establishment of manufacturing protocols, and conduct of phase 1 and phase 2 clinical trials.

Funding Amount: The funding amounts vary depending on the specific topic within the call. For example, HORIZON-HLTH-2025-01-TOOL-02 has a budget of EUR 40,000,000 with contributions ranging from EUR 9,000,000 to EUR 13,000,000 and an indicative number of 3 grants. Other topics have different budget allocations and contribution ranges.

Application Type: The application type is a single-stage open call.

Nature of Support: Beneficiaries will receive money in the form of grants to support their research and innovation activities.

Application Stages: The application process is a single-stage process.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight into the potential success rate. For example, HORIZON-HLTH-2025-01-TOOL-02 indicates 3 grants will be awarded.

Co-funding Requirement: The information does not explicitly state a co-funding requirement.

Summary: This Horizon Europe call focuses on advancing cell secretome-based therapies to address challenges in regenerative medicine. The goal is to support activities that translate innovative therapeutic approaches into healthcare solutions, improve manufacturing processes, and provide patients with access to new therapies. The call encourages participation from researchers, biopharmaceutical developers, clinicians, SMEs, and other relevant stakeholders. Projects should address the bottlenecks in secretome-based therapies, including understanding their mode of action, reproducibility, and quality assurance. The call requires applicants to conduct clinical trials and establish GMP-conform production processes. The geographic scope includes EU member states, associated countries, and legal entities established in the United States of America. The funding amounts vary depending on the specific topic, with a single-stage application process.