Fast Track Validation Programme – eight Projects selected

Call Announcement

The call documents of the EP PerMed Fast Track Validation Programme were published on 10 December 2024. The call is closed, but if you are interested in the original documents, you can read them here.

Personalised medicine represents a fundamental shift away from the traditional “one size fits all” approach. As defined in the European Council Conclusion on personalised medicine for patients (2015/C 421/03), it refers to a medical model using characterisation of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention. This approach has the potential to transform healthcare systems and deliver better outcomes for patients.

Launched in December 2024, the Fast Track Validation Programme provides up to €80,000 per project to support six-month validation studies. The primary goal is to enable promising innovations to advance by at least one Technology Readiness Level (TRL), bringing them closer to real-world implementation and adoption.

The call for proposals received an impressive 81 eligible pre-proposals, reflecting the breadth of innovation and interest in personalised medicine across Europe and beyond. Following a rigorous review and evaluation process:

  • 15 projects were invited to develop and submit a detailed project plan.
  • From these, 8 high-quality projects were selected for funding, representing a total investment of €640,000.

The selected projects cover diverse areas of personalised medicine innovation where each project will carry out structured validation activities in collaboration with top-tier validation centers, generating critical evidence and user feedback to strengthen their clinical, scientific, and market positioning.

The validation studies will run from September 2025 to February 2026, with results expected to enhance the maturity and readiness of these innovative solutions.

We are excited to present the selected projects, offering a closer look at the innovative research and solutions that are poised to drive the field of personalised medicine forward.

Funded Projects

Integra Therapeutics SL

Integra Therapeutics has developed FiCAT-CAR19/22, a next-generation cell therapy platform designed to advance CAR-T treatments for B-cell malignancies. By combining the precision of CRISPR with the efficiency of transposase systems, the platform enables site-specific insertion of large genetic constructs, overcoming the limitations of viral vectors. This innovation enhances therapeutic safety, stability, and durability while reducing antigen escape and improving patient outcomes. With a streamlined and cost-efficient manufacturing process, FiCAT-CAR19/22 positions Integra Therapeutics at the forefront of personalised medicine, making advanced cell therapies more effective and accessible.

Vector Bioscience Cambridge

Vector Bioscience has developed an innovative RNAi delivery platform based on metal-organic frameworks (MOFs) designed to overcome critical barriers limiting RNA molecules’ therapeutic potential. Our technology ensures effective protection, precise targeted delivery, and efficient endosomal escape of synthetic RNA molecules, enabling potent and selective gene silencing. In this validation project, we aim to conduct comprehensive in vivo studies using a KRAS knockdown model to rigorously assess our platform’s stability, pharmacokinetic (PK) profile, biodistribution, and toxicology. By validating our platform’s effectiveness in safely and precisely silencing gene expression, this project will significantly advance RNA therapeutics, unlocking new personalized medicine opportunities and attracting strategic industry partnerships.

R-nuucell

R-nuucell is a biotech startup focused on advancing precision oncology through the development of targeted therapies for KRAS-driven cancers. With KRAS mutations present in approximately 30% of all human cancers—particularly in pancreatic ductal adenocarcinoma (90%), colorectal cancer (40%), and non-small cell lung cancer (35%)—there remains a significant unmet medical need, as current treatments only address a small subset of mutations. To address this gap, the company has developed PMC79, a ruthenium-based metallodrug designed to specifically inhibit the most common KRAS mutations in colorectal and pancreatic cancers (G12D, G12V, and G13D). Validated both in vitro and in vivo, PMC79 has the potential to open new therapeutic possibilities in an underserved market segment.

DART Biosciences

DART Biosciences is developing a first-in-class, IP-protected platform that leverages regulatory T-cells (Tregs) for targeted delivery of genetic material to tissues affected by disease. Unlike current gene therapy delivery systems, which are largely limited to the liver, cannot be redosed, and often raise safety concerns, the DART platform uses engineered Tregs to achieve tissue-specific delivery without immune recognition. This novel approach combines the natural anti-inflammatory properties of Tregs with their ability to localize at sites of immune activation, opening new possibilities for treating conditions beyond the reach of existing therapies. The company’s lead indication is autosomal dominant polycystic kidney disease (ADPKD), a severe inherited disorder affecting approximately 300,000 patients in the United States, where progressive renal failure often leads to dialysis. By harnessing Tregs for precise therapeutic delivery, DART Biosciences aims to restore kidney function and expand the potential of gene therapy to a broader range of diseases.

Aptadel Therapeutics SL

Aptadel Therapeutics is developing a novel therapeutic approach to address metastatic cancer, the leading cause of cancer-related deaths. Current treatments for metastasis rely on highly toxic, non-specific chemotherapies that offer limited efficacy and significantly impair patient quality of life. Aptadel’s technology is based on RNA aptamers, or “chemical antibodies,” that bind with high affinity and specificity to the EphA2 receptor, which is overexpressed in a wide range of tumors. This targeted strategy selectively reduces the metastatic potential of cancer cells while sparing healthy tissue. The platform has demonstrated strong preclinical validation, showing inhibition of cell migration, invasion, and colony formation in multiple cancer cell lines, as well as reduced metastasis formation in mouse models. Aptadel Therapeutics now aims to advance the validation of its RNA aptamers as a pan-cancer anti-metastatic agent in CDX and PDX models of aggressive and hard-to-treat cancers.

Pre-Cure

Pre-Cure is redefining precision oncology with its Tumor-on-a-Chip platform, a multi-functional biomimetic device that replicates human physiology and the tumor microenvironment using patient-derived tissues. Designed to overcome the limitations of traditional in vitro models, which contribute to the 95% failure rate of oncology drugs in clinical trials, the platform enables precise treatment predictions to support personalised therapy and accelerate drug development. Currently under clinical validation in ovarian, head and neck, pancreatic, and advanced gastrointestinal cancers, the technology has the potential to impact more than one million patients annually across the United States and Europe. By improving treatment selection and drug development efficiency, Pre-Cure is working to transform cancer care and advance the field of personalised medicine.

Solid-IO

Solid IO is developing organ-on-chip technology that replicates patient-specific tumor biology ex vivo to provide real-time, personalised guidance for cancer therapy. By accurately mimicking the tumor microenvironment and preserving immune interactions, the platform delivers actionable data on individual responses to immunotherapies—addressing the limitations of conventional models and the trial-and-error approach that dominates current treatment decisions. With a focus on solid cancers, where immunotherapies are widely used but lack reliable predictors of response, Solid IO’s technology has the potential to significantly improve therapy selection and patient outcomes. Supported by EIT EP PerMed, the company is advancing clinical validation and co-development partnerships to accelerate integration of its platform into routine clinical decision-making worldwide.

Motion Informatics Ltd

Motion Informatics is pioneering next-generation neuromuscular rehabilitation by integrating AI-driven neuroinformatics, augmented reality (AR), and digital health into an adaptive therapeutic platform. Our Spatial StimelMD (SSMD) leverages patient-specific real-time electrophysiological data, biofeedback-driven neuromodulation, and AI-optimized assessment protocols to dynamically personalize electrical stimulation therapy, enhancing neuroplasticity, motor re-education, and functional recovery in conditions such as stroke, spinal cord injuries, and neuromuscular disorders. By fusing biomechanical modeling, predictive analytics, and remote neurorehabilitation, we are redefining precision rehabilitation, creating a highly scalable, intelligent, and data-driven ecosystem that bridges clinical and home-based care. This paradigm shift will establish fully autonomous, and continuously adaptive neuromuscular therapy, fundamentally transforming the future of digital healthcare.